Efemoral Medical has today announced the closing of its US$4.9 million preferred Series A1 round. Supported by existing investors as well as an experienced cohort of new investors, the proceeds will further Efemoral's device development and expand enrolment in...
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Ulf Teichgräber (Jena, Germany) talks to Vascular News at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain), about some of...
Boston Scientific has announced that it will make a partial offer to acquire a majority stake, up to a maximum of 65%, of shares of Acotec Scientific, a Chinese medical technology company that offers solutions designed for a variety...
Europe’s health commissioner, Stella Kyriakides, has announced that proposals to extend the transition period for the implementation of the European Union’s (EU) Medical Device Regulation (MDR) will be put forward in early 2023.
Kyriakides informed health ministers from the EU’s...
Endologix recently announced that it has received US Food and Drug Administration (FDA) approval for a premarket approval (PMA) supplement relating to the AFX2 system.
According to a company press release, Endologix received approval to include an updated warning and...
November's top 10 includes the first results from BEST-CLI, as well as new data presented at this year's Vascular Interventional Advances (VIVA; 31 October–3 November, Las Vegas, USA) and VEITHsymposium (15–19 November, New York, USA) meetings.
1. First data from...
Data have been presented for the first time at the Paris Vascular Insights (PVI) conference (23–25 November, Paris, France) from the ABISS trial, which compared drug-coated balloon (DCB) with plain-balloon angioplasty for arteriovenous fistula (AVF) stenosis.
ABISS was a physician-designed...
A prospective study has demonstrated the potential feasibility, applicability and accuracy held by artificial intelligence (AI) in the detection of carotid artery disease on greyscale static duplex ultrasound imaging. This is the conclusion reached by Ali Kordzadeh (Faculty of...
The President’s Symposium at the Vascular Society of Great Britain and Ireland (VSGBI) annual scientific meeting (23–25 November, Brighton, UK) featured Rob Sayers’ (University of Leicester, UK) presentation titled ‘CLTI CQUIN has raised the profile of PAD and will...
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“Patients who are on chronic dialysis really depend on arteriovenous (AV) access for their treatment,” Michael Lichtenberg (Arnsberg, Germany) tells Vascular News at the Cardiovascular and Interventional Radiological...
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion for ‘more freedom of action in the procurement of medical products for supply of the...
Otsuka Medical Devices and ReCor Medical, a subsidiary of Otsuka, announce the filing of the premarket approval (PMA) application to the US Food and Drug Administration (FDA) for the Paradise ultrasound renal denervation system (uRDN) system in the treatment of...
During a late-breaking clinical trials session at the 2022 Vascular Interventional Advances (VIVA) conference (31 October–3 November, Las Vegas, USA), Mehdi Shishehbor (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA) presented a patient-level, propensity-adjusted comparison of drug-coated balloons...
Thomas Maldonado (New York University Medical Center, New York, USA) speaks to Vascular News at the 2022 Vascular Interventional Advances (VIVA) conference (31 October–3 November, Las Vegas, USA) about how new interim data from the STRIDE study will impact...
Viz.ai recently announced new data from a large aortic dissection artificial intelligence (AI) real-world study that supports the use of its AI technology for the detection of suspected aortic dissection. Data from the new study, which were presented this...
The Sundance (Surmodics) sirolimus drug-coated balloon (DCB) has an “excellent” safety profile in a “challenging, real-world, predominantly CLTI population,” and has a primary patency rate of 80% at 12 months in a per-protocol analysis population. Ramon Varcoe (Prince...
Viz.ai has announced a partnership with Illuminate, a developer of proprietary natural language processing (NLP) and artificial intelligence (AI) software that discovers at-risk patients from electronic medical records (EMR), assesses disease severity, and facilitates follow-up surveillance for a variety...
Soundbite Medical Solutions announced that it has entered into an exclusive license agreement with VFLO Medical (VFLO).
Pursuant to the agreement, Soundbite has granted VFLO an exclusive license for certain proprietary products including its SoundBite crossing system and the Active...
Contego Medical has announced that enrolment of the PERFORMANCE II clinical trial has been completed.
PERFORMANCE II is intended to evaluate the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) three-in-one carotid stent and post-dilation balloon system with...
VentureMed Group has announced new data presentations on the treatment of peripheral arterial disease (PAD) with drug-coated balloon (DCBs) in addition to 12-month AV Registry Data. These presentations will be given as part of the VEITH Symposium Annual Scientific...
Genesis MedTech Group announced that the US Food and Drug Administration (FDA) has approved the Chocolate Touch drug-coated balloon (DCB) percutaneous transluminal angioplasty (PTA) catheter, developed by TriReme Medical, for the treatment of patients with peripheral arterial disease (PAD)...
Xeltis announced today the initiation of a pivotal trial with the “first-ever” restorative synthetic haemodialysis access graft, dubbed ‘Axess’.
The first two patients have been successfully implanted as part of the AXESS European pivotal trial at AZ Sint-Jan Brugge-Oostende AV...
ReCor Medical and its parent company, Otsuka Medical Devices, announced consistent and significant blood pressure-lowering results across a range of patients with uncontrolled hypertension, including across differences in age, sex, baseline blood pressure, medication level and ethnicity. The results...
Medtronic has announced the six-month results from the full cohort of the SPYRAL HTN-ON MED clinical trial. The late-breaking data were presented at the American Heart Association (AHA) Scientific Sessions 2022 (5–7 November, Chicago, USA). With this news, Medtronic has...
Five-year outcomes from the randomised SPACE-2 trial on carotid artery stenosis, an interview with Joseph S Coselli, and a report on the "significant" increase in atherectomy use in the USA caught readers' attention in October.
1. Randomised trial finds carotid...
The first results from the BEST-CLI randomised controlled trial (RCT) of 1,830 patients show that surgical bypass with adequate single-segment great saphenous vein (GSV) is a more effective revascularisation strategy for patients with chronic limb-threatening ischaemia (CLTI) who are...
Researchers led by a vascular team in Indianapolis found that carotid endarterectomy (CEA) remains the most-used strategy in carotid revascularisation, with CEA and transcarotid artery revascularisation (TCAR) showing decreased odds of stroke or death compared to transfemoral carotid artery...
Christopher Kwolek (Massachusetts General Hospital and Harvard Medical School, Boston, USA) presented five-year results from the LEOPARD randomised controlled trial (RCT) during a late-breaking clinical trial session at the 2022 Vascular Interventional Advances (VIVA) conference (31 October–3 November, Las...
The final 1,373-patient cohort analysis from the Disrupt PAD III observational study (OS) demonstrates consistent intravascular lithotripsy (IVL; Shockwave Medical) outcomes in complex and challenging lesions across multiple peripheral vessel beds.
Ehrin Armstrong (Adventist Heart and Vascular Institute, St...
Six-month results from the PROMISE II trial of the LimFlow deep vein arterialisation system (LimFlow) showed an overall amputation-free survival of 66%—“well above” the primary endpoint target of 54%, chief investigator Daniel Clair (Vanderbilt University School of Medicine, Nashville,...
The Novo Nordisk Foundation has made a US$3.3 million contribution toward the BEST-CLI (Best endovascular versus best surgical therapy in patients with critical limb ischaemia) clinical trial, the Denmark-based entity has announced. The grant is set to be used...
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Matteo Tozzi (Varese, Italy) speaks to Vascular News at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain) about new analysis...
The American College of Cardiology (ACC) and American Heart Association (AHA) have jointly published new guidelines on the diagnosis and management of aortic disease.
The document, which has been published in both the Journal of the American College of Cardiology...
In the TRANSCEND clinical trial, the SurVeil drug-coated balloon (DCB; Surmodics) demonstrated "excellent efficacy and safety" out to 24-month follow-up. This is according to Kenneth Rosenfield (Massachusetts General Hospital, Boston, USA), who presented the new data at Vascular Interventional...
A patient-level, propensity-adjusted comparison of three-year results from a quartet of prospective, multicentre trials support the primary use of drug-coated balloons (DCBs) versus bare metal stents (BMS) in moderately complex femoropopliteal lesions, new data show.
Lead researcher Mehdi Shishehbor (Harrington...
At the 2022 Vascular Interventional Advances (VIVA) meeting (31 October–3 November, Las Vegas, USA), Michael Lichtenberg (Arnsberg Clinic, Arnsberg, Germany) reported a subgroup analysis of the MIMICS-3D EU registry, revealing a headline finding of “excellent” three-year outcomes for the...
Baylis Medical Technologies has announce it is assuming responsibility for the sales and distribution of the steerable and guiding sheaths currently sold direct-to-hospital by Oscor in the USA.
The addition of Oscor’s sheath portfolio will allow Baylis Medical Technologies to...
Concept Medical has announced the successful completion of enrolment for the SIRONA randomised controlled trial (RCT) investigating the use of its Magic Touch PTA sirolimus drug-coated balloon (DCB) versus paclitaxel DCB angioplasty for the treatment of peripheral artery disease...
Gerd Grözinger (Tübingen, Germany) chats with Bernhard Gebauer (Berlin, Germany) at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain) about some of the difficulties associated with treating patients with pulmonary embolism...
W L Gore & Associates (Gore) today announced the first implants of its investigational Gore Viafort vascular stent as part of the recently initiated Gore Viafort device pivotal clinical study for the treatment of inferior vena cava (IVC) occlusive...
Transit Scientific has announced that the XO RX 2.2Fr and XO RX 3.8Fr platform has received US Food and Drug Administration (FDA) clearance to crack, break and dilate stenoses in peripheral arteries and arteriovenous dialysis fistula-associated lesions.
"We have demonstrated...
W L Gore & Associates (Gore) has announced the completion of target enrolment in the EXPAND postmarket Registry of the Gore Viabahn VBX balloon-expandable endoprosthesis (VBX stent graft).
A press release details that 280 patients at 15 European sites...
This advertorial is sponsored by Cardionovum®.
The Aperto drug-coated balloon (DCB) technology (Cardionovum) is “one of the very promising new technologies” for treating central vein stenosis and restenosis in dialysis access patients, Michael Lichtenberg (Arnsberg Vascular Center, Arnsberg, Germany) tells Vascular...
Day three of CX Aortic Vienna Digital Edition (24–26 October) gave airtime to risk prediction and management for thoracoabdominal aortic aneurysm (TAAA) procedures. Presentations focused specifically on the “shaggy” aorta and spinal cord ischaemia post-thoracic endovascular aortic repair (TEVAR),...
Presentations and discussions at the CX Aortic Vienna 2022 Digital Edition (24–26 October) highlighted the fact that population screening for abdominal aortic aneurysm (AAA) is not reaching certain patient groups that might benefit from it, including women and racial...
This session really reminds clinicians that the answer is not always an intervention in 100% of patients.
There was general agreement between physicians from across the globe that there is “work to do” in the way abdominal aortic aneurysm (AAA) sac stability is measured and assessed, and in understanding the underlying, biological factors that influence sac...
This advertorial, sponsored by Inari Medical, is only available in selected countries and geographies.
Mechanical thrombectomy with the ClotTriever and FlowTriever systems (Inari Medical) opens up new possibilities for the management of deep vein thrombosis (DVT) and pulmonary embolism (PE),...
Heinz Jakob (Essen, Germany) and Tilo Kölbel (Hamburg, Germany) offer their respective cardiac and vascular surgery perspectives on the potential of some new techniques and technologies at the cutting edge of aortic advances. They detail how novel approaches such...
The need for vascular companies to home in on developing longer-lasting devices—perhaps even ones that adapt over time to match patients’ changing anatomies—was underscored as part of the Juxtarenal session on day two of the CX Aortic Vienna 2022...
The second day of the CX Aortic Vienna 2022 Digital Edition (24–26 October) saw presentations on dynamic computed tomography angiography (CTA), a device with the potential to bring hologram guidance to vascular procedures and an edited case highlighting the...
From parallel grafting to the role of hybrid operating rooms, the importance of vascular surgeons having a wide range of devices and options at their disposal was highlighted throughout yesterday’s CX Aortic Vienna juxtarenal sessions. As Roger Greenhalgh (London,...
The application of new technologies and techniques to treat challenging and high-risk thoracic aortic pathologies were highlighted by aortic specialists on day one of the third annual CX Aortic Vienna meeting (24–26 October, Digital).
Experience in endovascular arch repair in...
State-of-the-art open and endovascular techniques for the treatment of pararenal and juxtarenal aortic aneurysms were put under the microscope of the specialist aortic team from San Raffaele Hospital (Milan, Italy), led by Roberto Chiesa, on day one at CX...
There was consensus on day one of the CX Aortic Vienna 2022 Digital Edition (24–26 October) that aortic sac regression is a positive sign and that, following endovascular aneurysm repair (EVAR), it is important to monitor any sac increase...
Concept Medical has announced the completion of patient enrolment in the SIRONA trial. According to the company, this is the world's first and the largest head-to-head randomised controlled trial (RCT) investigating the use of a sirolimus drug-coated balloon (DCB;...
In the USA, atherectomy use in peripheral vascular interventions (PVIs) “more than doubled” from 2010 to 2019, with office-based procedures a “major driver” of this increase. This is according to published US data from the Vascular Quality Initiative (VQI),...
“We have to work together to pool data that demonstrate equivalence or superiority to open surgical repair,” Gustavo Oderich (University of Texas Health Science Center at Houston, Houston, USA) said of endovascular thoracoabdominal aortic aneurysm (TAAA) repair at this...
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A list of 10 key research priorities intended to help standardise vascular access research were delivered to attendees at this year’s Vascular Access Society of Britain and Ireland (VASBI) annual scientific meeting (29–30 September, Glasgow, UK). Presenter Jonathan de...
In this issue:
ESVS publishes "pioneering" clinical practice guidelines on radiation safety
What to expect from CX Aortic Vienna 2022
In profile: Markus Steinbauer (Regensburg, Germany)
Interview: Janet Powell (London, UK) speaks to Vascular News about the WARRIORS trial on...
In this issue:
ESVS publishes "pioneering" clinical practice guidelines on radiation safety
What to expect from CX Aortic Vienna 2022
In profile: Markus Steinbauer (Regensburg, Germany)
Interview: Janet Powell (London, UK) speaks to Vascular News about the WARRIORS trial on...
Cordis today announced its acquisition, subject to customary closing conditions including regulatory approvals, of MedAlliance.
A press release notes that the agreement includes an initial investment of US$35 million and US$200 million payment upon closing in 2023, regulatory achievement...
Cardiovascular Systems Inc (CSI) has announced the full market release of the 2.00 Max Crown for peripheral orbital atherectomy systems (2.00 Max Crown).
CSI notes in a press release that the 2.00 Max Crown is uniquely designed to enable simultaneous modification...
Medtronic has announced the 36-month final results from the ABRE clinical study. The purpose of the ABRE clinical study was to evaluate the safety and effectiveness of the company's Abre venous self-expanding stent system, intended for the treatment of...
In a recently published study, the introduction of endovascular aneurysm repair (EVAR) into the management of ruptured abdominal aortic aneurysm (AAA) decreased the 30-day mortality in unstable patients. Authors Melissa Jones (Peter Lougheed Centre, Calgary, Canada) and colleagues write...
A software named PRAEVAorta (Nurea), using artificial intelligence (AI), has the potential to enable a fast, reproducible, and fully automated analysis of abdominal aortic aneurysm (AAA) sac pre- and post-endovascular aneurysm repair (EVAR). This is according to Caroline Caradu...
Five-year outcomes of a multicentre, randomised controlled trial (RCT) indicate that carotid endarterectomy (CEA) or carotid artery stenting (CAS) are not superior to best medical therapy (BMT) alone for moderate-to-severe asymptomatic carotid artery stenosis.
Tilman Reiff (University Hospital of...
Joseph S Coselli (Baylor College of Medicine, Houston, USA) speaks to Vascular News about his career to date. Despite initially planning to follow in his family’s footsteps and attend law school, a summer internship at the Texas Heart Institute...
New findings, recently published in the Journal of Vascular Access (JVA), provide insight into the haemodialysis access profile of failed kidney transplant patients treated in the Catalonia region of Spain over an 18-year period.
Researchers Ramon Roca-Tey (Hospital Universitari Mollet, Barcelona,...
Six-month data from the Surmodics SWING first-in-human (FIH) study of the company’s Sundance sirolimus drug-coated balloon (DCB) were shared at the 2022 Amputation Prevention Symposium (AMP; 9–11 October, Lugano, Switzerland).
The SWING study is a prospective, multicentre, single-arm feasibility study...
Endologix has announced the submission of a premarket approval (PMA) application requesting approval for the Detour system to the US Food and Drug Administration (FDA).
The Detour system, which earned FDA Breakthrough Device Designation, is a unique therapy that allows...
Cydar Medical today announced that Alastair Harvey has been appointed in the newly created position of chief commercial officer, reporting to chief executive officer Paul Mussenden.
The new role reflects the company’s customer-centric focus during a stage of growth and...
Thomas Rand (Klinik Florisdorf, Vienna, Austria) recently presented on the preliminary results to 12 months of the Motiv bioresorbable scaffold (Reva Medical) postmarket trial at the recent Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14...
The chance of a patient surviving after an acute type A aortic dissection has improved significantly, but mortality remains high if not recognised early and repaired surgically. This is according to new research from a team at Michigan Medicine...
September's top 10 highlights a randomised trial that aims to examine early endovascular aneurysm repair (EVAR) in women, new radiation safety guidelines from the European Society for Vascular Surgery (ESVS), and the latest data from renal denervation trials, among...
Xeltis today announced what it describes as “very promising” preliminary efficacy and safety results from one of the centres participating in the AXESS study—a first-in-human (FIH) clinical trial of its restorative haemodialysis access graft, Axess.
The company has also reported...
Terumo Aortic today announced that the US Centers for Medicare and Medicaid Services (CMS) has granted approval of a new technology add-on payment (NTAP) for Terumo Aortic’s Thoraflex Hybrid device under the inpatient prospective payment system (IPPS).
Thoraflex Hybrid is...
Truveta announced a strategic collaborative agreement with Boston Scientific to improve long-term patient care and gain insights into healthcare disparities. Through this collaboration, Boston Scientific researchers will be able to access data from Truveta, which contains de-identified medical records...
Humacyte recently announced the presentation of a clinical update on the Human Acellular Vessel (HAV) for the treatment of vascular trauma. The update was presented by Ukrainian surgeon collaborators, Oleksandr Sokolov (Dnipro State Medical University, Dnipro, Ukraine) and Vasyl...
Ulf Teichgräber (Jena, Germany) and Edward Choke (Singapore) discuss—at the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK)—some of the key benefits of sirolimus-coated balloons and the key differences between these devices and ones coated with paclitaxel.
One...
Penumbra and Asahi Intecc, a Japanese medical device manufacturer, announced that they will collaborate to introduce Penumbra’s Indigo Aspiration System into the Japanese market upon regulatory approval.
“By bringing together our newest innovations with Asahi’s leadership and expertise in the...
The European Society for Vascular Surgery (ESVS) has released clinical practice guidelines on radiation safety, which the writing committee notes are the first guidelines on the topic to be published under the auspices of a vascular surgical society. The...
Day one of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2022 annual meeting (10–14 September, Barcelona, Spain) put a strong focus on peripheral arterial disease (PAD). At a FIRST@CIRSE session, Hans van Overhagen (Haga Teaching Hospital, Den...
The Annals of Vascular Surgery peer-review journal has announced an upcoming special issue dedicated to original work by women that is set to be guest edited by Caitlin W Hicks (Johns Hopkins Medicine, Baltimore, USA).
The issue, which will be...
Medtronic announced that it has recently received CE mark for its Radiant balloon-expandable covered stent, the first and currently, only, covered stent indicated for use in chimney endovascular aneurysm repair (ChEVAR) with the Endurant II/IIs stent graft system.
Used together,...
Terumo Medical Corporation has announced late-breaking data showing the safety and efficacy of radial to peripheral (R2P) interventions with the R2P Misago self-expanding peripheral stent in lower extremity endovascular interventions via a radial approach. The results were presented at...
Findings from the RADIANCE II randomised pivotal trial, presented at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT, 16–19 September, Boston, USA), “confirm that ultrasound renal denervation lowers blood pressure across the spectrum of hypertension”.
RADIANCE II—results of which were described...
The Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) clinical registry announced this week it has now collected more than one million procedures in its database.
The SVS VQI is a not for profit clinical registry dedicated to improving...
This month a multinational collaboration of researchers received endorsement from the Global Cardiovascular Research Funders Forum (GCRFF) Multinational Clinical Trials Initiative for the WARRIORS (Women’s abdominal aortic aneurysm research: repair immediately or routine surveillance) trial.
The trial aims to answer...
In an observational cohort study of Medicare beneficiaries receiving haemodialysis, the use of an arteriovenous graft (AVG) compared with an arteriovenous fistula (AVF) was associated with an increased risk of deep vein thrombosis (DVT) and/or pulmonary embolism (PE). Conversely,...
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Said Abisi (London, UK) discusses inner branched endovascular aneurysm repair (iBEVAR) technology, which he describes as a good alternative to fenestrated EVAR (FEVAR) and side branches...
Haemonetics Corporation has received CE mark certification for its Vascade vascular closure and Vascade MVP venous vascular closure systems.
The CE marking will allow Haemonetics to engage in the next steps of country-specific entrance of both products into the...
Bentley today announced that it has acquired the rights of the GoBack catheter from Upstream Peripheral Technologies.
“The acquisition of the GoBack catheter marks the start of inorganic growth for Bentley,” said Sebastian Büchert, Bentley's CEO. “We launched our first...
Merit Medical Systems has announced the US commercial release of the Prelude Roadster guide sheath. The Prelude Roadster is the newest addition to the Merit Vascular-Peripheral Access portfolio, which includes introducers and other products, including access kits, vessel dilators,...
This advertorial is sponsored by Cardionovum®. DCB
Matteo Tozzi, associate professor of Vascular Surgery at the University of Insubria (Varese, Italy), speaks to Vascular News about a new analysis related to the residual presence of paclitaxel in the bloodstream after...
Silk Road Medical has announced enrolment of the first patient in ROADSTER 3, which the company claims is the the first prospective, multicentre, single-arm study to assess real-world treatment of standard surgical risk patients with carotid artery disease using...
This advertorial, sponsored by Inari Medical, is only available in selected countries and geographies.
“I am finally very confident I have a device that takes out all the thrombus,” stated Rick de Graaf (Clinical Centre of Friedrichshafen, Friedrichshafen, Germany)...
In this issue:
The centre volume-outcome relationship in aortic surgery: Time for international discussion
Study is first to elucidate lower limb amputation epidemiology in a Latin American low- and middle-income country
In profile: Joseph S Coselli (Houston, USA)
Top stories...
In this issue:
The centre volume-outcome relationship in aortic surgery: Time for international discussion
Study is first to elucidate lower limb amputation epidemiology in a Latin American low- and middle-income country
In profile: Joseph S Coselli (Houston, USA)
Top...
This advertorial is sponsored by Bentley.
The range and complexity of vascular pathologies that interventionalists face necessitates a complete and comprehensive solution. Bentley, with its coronary, peripheral and aortic iterations (ranging from 2.5 to 30mm) of the BeGraft balloon-expandable covered stent,...
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Thomas Zeller (Bad Krozingen, Germany) talks to Vascular News about the iliCo study, of which he is co-principal investigator, and which is designed to evaluate the...
The establishment of the first-ever global consensus for the appropriate use of intravascular ultrasound (IVUS) in lower extremity and arterial and venous interventions, results of a randomised controlled trial on community-based exercise in patients with an abdominal aortic aneurysm...
Andrew Wigham (Oxford, UK) and Rick De Graaf (Friedrichshafen, Germany) discuss the current state of deep vein thrombosis (DVT) treatment at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany), with both noting that “a massive problem” in...
Vascular Therapies has announced that the first patient in the ACCESS 2 clinical trial was enrolled by Nikhil Kansal at Harbor-UCLA Medical Center in Torrance, USA.
The Phase 3 prospective randomised ACCESS 2 study will enrol 120 patients from centres in the...
Shape Memory Medical has announced the completion of patient enrolment in AAA-SHAPE, the company’s prospective, multicentre early feasibility safety study of the Impede-FX RapidFill device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair...
A study recently published in the World Journal of Surgery claims to be the first to provide comprehensive population-level data on the epidemiology of lower extremity amputation (LEA) in a Latin American low- and middle-income country (LMIC). The investigators...
The first US patient has been enrolled in the US Food and Drug Administration (FDA) SELUTION4BTK (below-the-knee) clinical trial evaluating Selution SLR, MedAlliance's novel sirolimus-eluting balloon. This follows investigational device exemption (IDE) approval in the USA in May 2022,...
BD has announced the start of enrolment in a first-in-human trial of a peripheral sirolimus drug-coated balloon (DCB).
The PREVISION trial is a prospective, multicentre, single arm, non-randomised study designed to evaluate the safety of the BD sirolimus DCB in...
Results of a randomised controlled trial (RCT) point to the beneficial effects of a community-based exercise programme on outcomes in patients with an abdominal aortic aneurysm (AAA).
Researchers Adam Haque (Manchester University NHS Foundation Trust, Manchester, UK) and colleagues found...
A new imaging device at University of Texas (UT) Southwestern (Dallas, USA) is making complex aortic repairs safer for patients and operating room staff by dramatically reducing their exposure to radiation. The device, known as Fiber Optic RealShape (FORS;...
Motion analysis of video recorded on a smartphone accurately detected narrowed carotid arteries, according to new research published in the Journal of the American Heart Association.
"Between 2% and 5% of strokes each year occur in people with no symptoms, so...
CX Aortic Vienna returns in October for its third edition (24–26 October, Digital), bringing together world-leading specialists from the cardiac and vascular fields to discuss all facets of aortic care from selection to investigation, diagnosis, techniques and technologies. The...
Gore has announced the acquisition of InnAVasc Medical, a privately held medical technology company focused on advancing care for patients with end-stage renal disease who utilise graft circuits for dialysis treatment.
Jeffrey Lawson and Shawn Gage from Duke University School...
Royal Philips today announced an important milestone in the evolving standard of care for treating patients with peripheral vascular disease: the establishment of the first-ever global consensus for the appropriate use of intravascular ultrasound (IVUS) in lower extremity arterial...
This advertorial is sponsored by Bentley.
Launched in July 2020, the BeYond Venous self-expanding stent system (Bentley InnoMed GmbH) now has early clinical data and expert experience to support its use in venous interventions. In what Michael Lichtenberg (Arnsberg Vascular...
July's top 10 most popular items include more from this year's Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2022; 15–18 June, Boston, USA), new research on vascular health disparities between men and women, and an interview with...
AngioDynamics recently announced that it has received US Food and Drug Administration (FDA) 510(k) clearance of an expanded indication for the Auryon atherectomy system to include arterial thrombectomy.
The FDA recently cleared the expanded indication for the Auryon system’s 2mm...
Research from Ochsner Health (New Orleans, USA) published in the Journal of the American College of Cardiology (JACC) is likely to influence expanded insurance coverage for carotid artery stenting.
The paper, "Carotid artery stenting: JACC state-of-the art review", details significant advances...
Selution SLR, MedAlliance's sirolimus-eluting balloon, has received conditional US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA).
This comes only...
Endologix recently announced that is has received CE mark certification under the new EU Medical Devices Regulation (EU-MDR) for its AFX2 endovascular abdominal aortic aneurysm (AAA) system.
“CE mark certification under the new requirements is a high bar and we...
Andrew Holden (Auckland, New Zealand) and Michel Reijnen (Arnhem, The Netherlands) discuss Shape Memory Polymer (Shape Memory Medical)—a porous scaffold that, according to Holden, due to a high volume of surface area, provides “a high level of stasis and...
Shape Memory Medical announced today that its 1,500th patient has been treated, marking a significant milestone for the company’s portfolio of shape memory polymer embolotherapy devices—the Impede embolisation plug family and the TrelliX embolic coil. The patient was treated...
Concept Medical has announced the initiation of the LIMES trial, which has enrolled 15 patients to evaluate the safety and efficacy of the company's Magic Touch sirolimus-coated percutaneous transluminal angioplasty (PTA) balloon for the treatment of peripheral arterial disease...
Transit Scientific has reported multiple successful peripheral vascular procedures with the XO Cross catheter platform utilising pedal retrograde access.
The non-tapered 2Fr XO Cross 14 microcatheter in 90cm, 135cm, and 175cm lengths is designed to facilitate guidewire support, guidewire...
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Endologix president and CEO, Matt Thompson (Irvine, USA), discusses how the firm has “been transformed from a company purely focusing on the infrarenal aorta to a...
iVascular recently announced the first patient enrolment in the BARISTA study, a Belgian physician-initiated study to assess the efficacy and safety of the company's Restorer balloon-expanding stent for the treatment of aortoiliac lesions.
BARISTA is a prospective, single-arm, multicentre, physician-initiated...
Artivion announced today that it has initiated enrolment in the PERSEVERE clinical trial to determine if patients with an acute DeBakey Type I aortic dissection can be treated safely and effectively using the AMDS hybrid prosthesis. The trial is...
Walking for exercise at a pace that induced pain or discomfort improved walking ability among people with peripheral arterial disease (PAD), according to new research published today in the Journal of the American Heart Association (JAHA).
This study examined the effects of...
Biotronik recently announced that it has received US Food and Drug Administration (FDA) approval of its Pulsar-18 T3 peripheral self-expanding stent system. Full US commercial launch of the device, which will begin in early August, according to the company.
Biotronik...
Northeast Scientific, a company that reprocesses single-use peripheral vascular catheters, announced recently in a press release that it has received US Food and Drug Administration (FDA) clearance for reprocessing the Philips Spectranetics 0.9mm over-the-wire Turbo-Elite laser atherectomy catheter.
This...
ReCor Medical and Otsuka Medical Devices have announced that the RADIANCE II US Food and Drug Administration (FDA) investigational device exemption (IDE) pivotal trial evaluating the Paradise ultrasound renal denervation (uRDN) system as a treatment for hypertension met its...
Intraoperative ultrasonographic venous mapping is a useful tool to evaluate vessel suitability for arteriovenous fistula (AVF) creation, Yana Etkin (Zucker School of Medicine at Hofstra/Northwell, Lake Success, USA) concluded at this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting...
In a study recently published in Circulation, researchers found that Black adults underwent significantly more endovascular peripheral vascular interventions (PVI), were treated for more advanced disease and were also more likely to experience adverse outcomes following PVI procedures, including amputation...
Bentley has announced that recruitment is now complete in the fenestrated endovascular aortic aneurysm repair (FEVAR) study that uses the company's BeGraft peripheral balloon-expandable covered stent as a bridging stent in complex aortic aneurysms.
Led by Eric Verhoeven (General Hospital...
Women are more likely to die within five years of having elective surgery to repair an abdominal aortic aneurysm (AAA) or need repeat surgery, according to a recent study.
Writing in the Journal of Vascular Surgery, Taylor Corsi (Rutgers University, Piscataway, USA)...
Thrombolex has announced that its board of directors has named Michael Cerminaro chief executive officer (CEO) effective 13 July 2022, the date of the company’s most recent quarterly board meeting.
The company advises Cerminaro will also retain his current title...
Cordis has announced the start of the RADIANCY premarket clinical study in Europe.
A press release details that RADIANCY is a prospective, multicentre, single-arm study to assess the safety and efficacy of the S.M.A.R.T. Radianz vascular stent system intended...
SoniVie today announced that on 30 May this year the first patient was treated with its renal artery denervation Tivus therapeutic intravascular ultrasound technology, as part of the recently US Food and Drug Administration (FDA) investigational device exemption (IDE)-approved REDUCED1...
Coverage of this year's Leipzig Interventional Course (LINC; 6–9 June, Leipzig, Germany) and Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM; 15–18 June, Boston, USA) proved popular amongst Vascular News readers in June, as did some new research...
Alexander Zimmermann (University Hospital Zurich, Zurich, Switzerland) tells Vascular News about his career to date, beginning with a rotation in vascular surgery that opened up “a whole new world of medicine” to his directorship of the Department of Vascular...
Artificial intelligence (AI) models can be developed to predict the risk of postoperative complications after endovascular aneurysm repair (EVAR) with “high accuracy,” research presented at this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2022; 15–18 June, Boston,...
A new US study has found that female sex is associated with more reinterventions after surgical treatment for intermittent claudication. Additionally, guideline-directed medical therapy, including aspirin and statin use, was used less frequently among female compared with male patients...
“Vascular surgery is my DNA”, Alan Lumsden (Houston, USA) tells Vascular News, as he discusses the role of vascular surgeons in the cardiac surgery world. He highlights that on his programme, “three out of five of our last finishing trainees...
A prospective, multicentre study involving the Covera vascular covered stent (BD) has confirmed the benefits of immediate, post-percutaneous transluminal angioplasty (PTA) placement of the device in treating arteriovenous graft (AVG) venous anastomotic stenosis when anatomically and clinically suitable. Writing...
Biotronik recently announced the presentation of two studies on the performance of its drug-coated balloon (DCB) catheter Passeo-18 Lux at the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig, Germany).
The BIO REACT study was designed to better understand when and...
Access Vascular has shared initial findings from a retrospective review of patient records that demonstrate an increase in dwell times compared to other commercially available devices and no complications when using the company’s consistently hydrophilic materials for midline catheters.
As...
Ra Medical Systems has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for the company’s Dabra 2.0 catheter as part of the Dabra excimer laser system. A company press release details that the catheter features enhancements...
Merit Medical has announced the successful enrolment of the first patient in its WRAP registry study in a press release. This study will evaluate the clinical benefits associated with the use of the Wrapsody cell-impermeable endoprosthesis in patients receiving...
Following the recent approval by the US Food and Drug Administration (FDA) of the Thoraflex Hybrid frozen elephant trunk (FET) device for the treatment of patients with complex aortic arch disease, Terumo Aortic has now announced the first commercial...
Cydar Medical, in partnership with King’s College London, has initiated the ARIA study—a randomised controlled trial to assess the clinical, technical and cost-effectiveness of a cloud-based, artificially intelligent image fusion system in comparison to standard treatment to guide endovascular...
Transit Scientific had shared via press release successful outcomes on multiple fistula and graft cases using its XO Score sheath platform, a first-of-its-kind metal-alloy scoring, cutting, and constraining structure (CS) device, along with off-the-shelf percutaneous transluminal angioplasty (PTA) balloons.
XO...
A University of Texas at Arlington (UTA; Arlington, USA) bioengineer is leading a project that will develop biodegradable nanomaterials that will take pictures and deliver medicine to combat peripheral arterial disease (PAD), the university announced in a press release.
Kytai...
Bluegrass Vascular Technologies recently announced the publication of a paper featured on the cover of the June 2022 issue of the Journal of Vascular Surgery (JVS). The paper reports the use of the company’s Surfacer system to perform an ‘Inside-Out’ procedure and obtain...
The use of systemic heparin during thoracic endovascular aneurysm repair (TEVAR) for blunt thoracic aortic injuries (BTAI) appears to be safe in selected patients with traumatic brain injury (TBI), a new study presented at this year’s Society for Vascular Surgery...
A mobile phone-administered, home-based exercise therapy programme for patients with intermittent claudication (IC) incorporating cognitive behaviour therapy (CBT) was found to be feasible, with 78% of participants completing the whole course, this year’s Society for Vascular Surgery (SVS) Vascular Annual...
Intravascular Lithotripsy (IVL; Shockwave Medical) gives physicians “the option to treat a patient efficiently without implanting something like a stent, which would limit further treatment,” Enrique Alejandre Lafont (St Gallen, Switzerland) tells Vascular News at the 2022 Charing Cross (CX)...
A Laminate Medical Technologies press release reports that the US VasQ external support comparative study results were presented this month for the first time globally at the Vascular Access Society of the Americas (VASA) 2022 Vascular Access for Hemodialysis...
Humacyte today announced that the first Ukrainian patients have received implants of the Human Acellular Vessel (HAV) for the treatment of vascular trauma injuries. The implants are part of Humacyte’s humanitarian relief initiative to provide investigational HAVs to multiple...
SoniVie recently announced that on 5 May 2022 the US Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval for its REDUCED1 pilot study to treat resistant hypertension patients with renal artery denervation using the company's therapeutic...
Pooled patient-level data from more than 2,500 asymptomatic, non-octogenarian subjects have shown that carotid artery stenting (CAS) achieved comparable short- and long-term results to carotid endarterectomy (CEA). The findings of this analysis have been published by Jon Matsumura (University...
Fenestrated/branched endovascular aneurysm repair (F/BEVAR) is associated with high technical success and low mortality in patients with chronic post-dissection thoracoabdominal aortic aneurysm (PD-TAAA). This conclusion was presented by Mohamed A Abdelhalim (St Thomas’ Hospital, London, UK), who detailed a...
In a study of over 7,000 chronic limb-threatening ischaemia (CLTI) patients, researchers found that Black and Hispanic patients had higher three-year amputation and reintervention rates; survival, however, was higher among Black patients and similar between Hispanic and White patients....
Cordis recently announced the first-in-human use of the Radianz radial peripheral system by Jihad Mustapha at Advanced Cardiac & Vascular Centers (ACV) in Grand Rapids, USA.
The Radianz radial peripheral system solution includes Brite Tip Radianz guiding sheath used to...
Artio Medical today announced the closing of US$28 million in oversubscribed Series A2 and Series A3 financing, bringing the total amount raised by the company to date to US$74 million.
Funds will be used to support US commercialisation efforts for the recently cleared...
Raphaël Coscas (Paris, France) talks to Vascular News about his introduction to Intravascular Lithotripsy (IVL; Shockwave Medical) and his initial experiences with the technology in treating patients with heavily calcified lesions. Speaking at the 2022 Charing Cross (CX) International Symposium...
Silk Road Medical today announced a post-market study to evaluate the transcarotid artery revascularisation (TCAR) system in the treatment of standard surgical risk patients with carotid artery disease.
The ROADSTER 3 study will fulfil the US Food and Drug...
M.I.Tech is the creator of the HANAROSTENT technology, a family of conformable, non-vascular, self-expanding metal stents, which have been distributed by Boston Scientific in Japan since 2015. The agreement consists of a purchase price of KRW 14,500 per share, which represents a...
Royal Philips today announced the latest results from the Tack optimised balloon angioplasty (TOBA) II below-the-knee (BTK) clinical trial, demonstrating that the Philips endovascular system—Tack (4F)—provides a sustained treatment effect and positive impact on quality of life for patients...
Two-year data on the use of intravascular lithotripsy (IVL) in calcified peripheral disease treatment, an advertorial sponsored by Bentley exploring the role of bridging stents in complex aortic procedures, and new guidelines on the management of atherosclerotic carotid and...
One-year outcomes from the BELSTREAM trial add to a growing pool of data that covered stents are safe and effective in the treatment of complex aortoiliac occlusive disease (AIOD).
At the Leipzig Interventional Course (LINC) 2022 (6–9 June, Leipzig,...
Based on over four years of experience in a single centre, Robert Shahverdyan (Asklepios Klinik Barmbek, Hamburg, Germany) claims that endovascular arteriovenous fistula (endoAVF) creation “keeps future options open,” but is not a replacement for surgical fistula creation.
Speaking at...
New data provide “another argument” for the use of intravascular ultrasound (IVUS) in below-the-knee (BTK) interventions. This is according to Michael Lichtenberg (Arnsberg Vascular Center, Arnsberg, Germany), who presented one-year outcomes from the PRESTIGE pilot study at the Leipzig...
The first patient has been enrolled in the US Food and Drug Administration (FDA) investigational device exemption (IDE) below-the-knee (BTK) SELUTION4BTK clinical trial involving SELUTION SLR, MedAlliance’s sirolimus-eluting balloon.
Michael Lichtenberg, chief of the angiology department at the Klinikum Hochsauerland...
Arjo has announced the development of a new intraoperative Doppler system that includes a single-use, sterile intraoperative probe and Dopplex DMX Vascular Doppler.
This latest system provides immediate evidence of a successful vascular reconstructive procedure by capturing the bloodflow waveforms...
Cydar Medical has announced a collaboration with Brainlab, enabling its Cydar EV Maps augmented intelligence software to integrate with Brainlab’s Buzz digital information hub.
According to a company press release, this allows endovascular surgeons to use advanced surgical visualisation and...
The risk of having a future stroke caused by asymptomatic carotid stenosis is “so low” that most patients with this condition could potentially be treated with the newest medications and may not require surgery. That is according to new...
Cagent Vascular has announced the expansion of its product offering to include larger balloons to treat superficial femoral and popliteal arteries in the above-the-knee (ATK) segment.
The company launched its Serranator below-the-knee (BTK) product in January 2021. Since then,...
Silk Road Medical recently announced that the Centers for Medicare and Medicaid Services (CMS), through collaboration with the Society of Vascular Surgery’s Patient Safety Organization (SVS PSO) and their Vascular Quality Initiative (VQI), has expanded coverage for transcarotid artery...
Cardio Flow has announced it recently received US Food and Drug Administration (FDA) clearance for the company’s FreedomFlow peripheral guidewire.
According to a company press release, the FreedomFlow guidewire features a stainless steel core-to-tip design with a fixed distal-spring coil...
Medtronic has announced approval from the US Food and Drug Administration (FDA) for the IN.PACT 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon (DCB), indicated for the interventional treatment of peripheral arterial disease (PAD) in the...
MedAlliance’s Selution SLR drug-eluting balloon (DEB) has received investigational device exemption (IDE) approval from the US Food and Drug Administration, making it the first limus DEB to be available to US patients, the company announced in a press release.
The...
VentureMed Group recently announced that it has completed enrolment of a randomised controlled trial (RCT) titled 'Flex Vessel Prep prior to PTA for the treatment of obstructive lesions in the native AVF'. This RCT was conducted to assess primary...
Shockwave Medical and Genesis MedTech Group announced today that they have successfully obtained approval from China’s National Medical Products Administration (NMPA) to market and sell the Shockwave intravascular lithotripsy (IVL) system with the Shockwave C2 coronary IVL catheters and...
The European Society for Vascular Surgery (ESVS) has just released 2023 clinical practice guidelines on the management of atherosclerotic carotid and vertebral artery disease. The guideline document, authored by chairperson Ross Naylor (Leicester Vascular Institute, Leicester, UK), co-chairperson Barbara...
New long-term data from the SAFE-PAD (Safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices) study were presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2022 Scientific Sessions (19–22 May, Atlanta, USA)....
Vesalio recently announced that it has oversubscribed its Class A financing round. Solas BioVentures led the investment with participation by new and existing investors, including the recent addition of Orlando Health Ventures.
With an expanding customer base established in Europe,...
Shockwave Medical announced today that long-term data from the Disrupt PAD III trial found that superior vessel preparation with intravascular lithotripsy (IVL) led to excellent long-term outcomes out to two years with preservation of future treatment options compared to...
Late-breaking trial data presented at EuroPCR 2022 (17–20 May, Paris, France) underscore the potential of renal denervation as an adjunctive therapy to treat hypertension, complementing existing first-line treatments including lifestyle modifications and medication, attendees of the conference heard.
Day one...
This advertorial, sponsored by BD, is only available in selected countries and geographies.
“Percutaneous mechanical thrombectomy debulks thrombus load, leading to rapid revascularisation for an occluded dialysis arteriovenous graft (AVG) on an ambulatory basis,” Samuel Heller (Charles University, Prague,...
At the time of carotid endarterectomy (CEA), surgeons should consider single antiplatelet therapy (SAPT) rather than dual antiplatelet therapy (DAPT). This is the conclusion of a new meta-analysis—reportedly the largest conducted on the topic to date—published in the European...
Vivasure Medical has announced the closing of the first tranche of €22 million (US$23 million) as part of its Series D financing round that could reach up to €52 million (US$54 million) in total.
The company states that the...
Andriy Nykonenko and Pirkka Vikatmaa outline how the European Society for Vascular Surgery (ESVS) is helping vascular surgeons in Ukraine continue to provide medical care amidst the ongoing crisis.
The world has been deeply affected by the violent and needless...
This advertorial is sponsored by Shape Memory Medical.
Smart Polymer is a new shape memory polymer technology, available to endovascular specialists, that is incorporated into the Impede embolisation plug family (Shape Memory Medical). Andrew Holden, an interventional radiologist at Auckland...
In this issue:
Community-focused approach required to tackle global issue of unnecessary amputations
Perioperative outcomes of carotid endarterectomy not improved on dual versus single antiplatelet therapy
CX 2022 Podium 1st coverage: IN.PACT AV Access 36-month results, artificial intelligence in aortic...
In this issue:
Community-focused approach required to tackle global issue of unnecessary amputations
Perioperative outcomes of carotid endarterectomy not improved on dual versus single antiplatelet therapy
CX 2022 Podium 1st coverage: IN.PACT AV Access 36-month results, artificial intelligence in...
Gore recently announced that the US Food and Drug Administration (FDA) has approved the Gore Tag thoracic branch endoprosthesis (TBE) for the endovascular repair of lesions of the descending thoracic aorta, while maintaining flow into the left subclavian artery...
This advertorial is sponsored by Bentley.
Bridging stents have been used in fenestrated and branched endovascular aneurysm repair (F/BEVAR) for many years. However, their use has always been off-label. In cooperation with Bentley, two investigator-initiated studies are set to create...
A real-world claims data analysis of nearly 200,000 patients with chronic limb-threatening ischaemia (CLTI) showed that female patients were older, underwent vascular procedures less often, and received guideline-recommended drugs less frequently. However, it also highlighted that female sex was...
Germany-based endovascular simulator supplier Cathi has joined forces with UK-based Vascular Simulation Solutions (VSS) to offer the world’s first online training masterclass using endovascular simulation coupled to a structured curriculum, the company said in a press release.
At its...
The results of a small-scale pilot study from Asia have indicated “potentially disappointing” results with a novel drug-eluting balloon in treating dysfunctional arteriovenous access for dialysis. These findings were delivered by Tjun Tang (Singapore General Hospital, Singapore)—who also highlighted...
NOTE: This video is ONLY available to watch in selected countries and geographies
In a late-breaking Podium 1st presentation at the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK), Andrew Holden (Auckland, New Zealand) revealed that patients...
The existing evidence on whether women with carotid stenosis experience inferior treatment outcomes compared to men is mixed—and this uncertainty is reflected in the current clinical guidelines. Seemant Chaturvedi (Baltimore, USA) assesses this evidence and outlines how it may...
Clark Zeebregts (University Medical Centre Groningen, Groningen, The Netherlands) and Kosmas Paraskevas (Central Clinic of Athens, Athens, Greece) answer some key questions about the 2023 European Society for Vascular Surgery (ESVS) clinical practice guidelines on the management of atherosclerotic...
Results from the multicentre, retrospective ODYSSEUS study carried out in The Netherlands suggest that less frequent surveillance after endovascular aneurysm repair (EVAR) may be warranted. However, authors Anna C M Geraedts (Amsterdam University Medical Centres, Amsterdam, The Netherlands) and...
April's top 10 most popular stories include US Food and Drug Administration (FDA) approval of a frozen elephant trunk (FET) device, as well as new data presented at the American College of Cardiology’s annual scientific sessions (ACC.22, 2–4 April,...
The Society for Cardiovascular Angiography & Interventions (SCAI) has released a position statement outlining competencies for endovascular specialists who provide care for chronic limb-threatening ischemia (CLTI).
The first-of-its-kind document, “SCAI/ACR/APMA/SCVS/SIR/SVM/SVS/VESS position statement on competencies for endovascular specialists providing CLTI...
This advertorial is sponsored by Shape Memory Medical.
Smart Polymer is a new shape memory polymer technology, available to endovascular specialists, that is incorporated into the Impede embolisation plug family (Shape Memory Medical). Michel Reijnen, a vascular surgeon at Rijnstate...
At the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK), Tom Carrell (Cydar Medical, Barrington, UK) delivered a Podium 1st presentation titled "Making endovascular aortic repair outcomes more predictable: Artificial intelligence takes on a 20-year-old challenge".
“Given...
Elective abdominal aortic aneurysm (AAA) repair in patients with a cancer diagnosis is associated with several poor postoperative outcomes according to a newly published study from researchers at the University of Missouri School of Medicine.
“Due to the strong association...
iVascular has announced the initiation of its first trial with the new generation covered stent iCover—the iliCo study. The study has the objective of evaluating the safety and effectiveness of iCover for the treatment of de novo aorto-iliac atherosclerotic...
Silk Road Medical recently announced that the US Food and Drug Administration (FDA) approved expanded indications for the company's Enroute stent to include patients at standard risk for adverse events from carotid endarterectomy (CEA). Previously, the stent was approved...
The 36-month results from the IN.PACT AV Access study (Medtronic)—which were presented for the first time during at the 2022 Charing Cross (CX) International Symposium (26–28 April, London, UK)—indicate that end-stage kidney disease (ESKD) patients treated with the IN.PACT...
Surmodics has announced that its Pounce thrombectomy system achieved 100% technical success in 20 first-in-human (FIH) procedures. The FIH data were presented by Gary Ansel (Columbus, USA) at the 2022 Charing Cross (CX) Symposium (26–28 April, London, UK).
Technical success...
New long-term data presented at the 2022 Charing Cross (CX) Symposium (26–28 April, London, UK) demonstrate the safety of Biotronik’s Passeo-18 Lux paclitaxel drug-coated balloon (DCB) for the treatment of peripheral arterial disease (PAD) in infrainguinal arteries.
The independent analysis...
The preliminary results from a clinical trial assessing a restorative haemodialysis access graft have shown promising early puncturing, patency and safety data. These findings from an ongoing first-in-human study of the Axess graft (Xeltis) are being presented for the...
Medtronic has announced that Laura Mauri has been appointed as the company’s chief scientific, medical and regulatory officer. This appointment adds to Mauri's prior responsibilities as chief clinical and regulatory officer, aligning and integrating the company's scientific, medical, clinical research...
Terumo Aortic has announced that the US Food and Drug Administration (FDA) has granted approval of the Thoraflex Hybrid frozen elephant trunk (FET) device for commercial sale in the USA for the treatment of patients with complex aortic arch...
Cydar Medical recently announced it has entered a strategic collaboration with Medtronic. Under the pilot arrangement, Cydar’s EV Maps software will be introduced to up to 40 new global sites, combining Cydar’s augmented intelligence technology with Medtronic’s services and...
Penumbra has announced that its Indigo aspiration system with Lightning 7 and Lightning 12 have secured CE mark and are now commercially available in Europe. Both technologies are part of Penumbra’s Indigo aspiration system—now with Intelligent Aspiration for mechanical...
Corindus, a Siemens Healthineers company, announced today the opening of its new headquarters at 275 Grove Street in Newton, USA. Siemens Healthineers relocated the Corindus headquarters from its previous location in Waltham, USA to accommodate company growth, doubling the...
NOTE: This video is ONLY available to watch in selected countries and geographies
Marianne Brodmann (Medical University of Graz, Division of Angiology, Austria) talks about the clinical results of the EMINENT randomised controlled trial, arguing that drug-eluting stents (DES)...
Alucent Biomedical announced in a press release that it has enrolled the first patient in ACTIVATE II, an Australia-based first-in-human clinical trial to evaluate the safety and efficacy of its natural vascular scaffolding (AlucentNVS) technology. The therapy is designed...
Truvic Medical, a wholly owned subsidiary of Imperative Care, announced in a press release that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Prodigy thrombectomy system, designed for the treatment of peripheral...
This educational supplement is only available in selected countries and geographies.
In this supplement, sponsored by Shockwave Medical:
Marianne Brodmann (Medical University of Graz, Graz, Austria) gives an overview of recent data on Intravascular Lithotripsy (IVL), outlines early...
Long-term data from the first 80 patients in the SPYRAL HTN-ON MED trial have been presented during a featured clinical research session at the American College of Cardiology’s annual scientific sessions (ACC.22, 2–4 April, Washington DC, USA).
The data, which...
A review of intraoperative adverse events in patients treated with fenestrated and branched endovascular aneurysm repair, meta-analysis findings on peripheral arterial disease symptoms in men vs. women, and an interview with Palma Shaw (Syracuse, USA) caught readers' attention in...
LimFlow recently announced it has closed a US$40 million (€36 million) oversubscribed Series D financing round.
A press release reports that new investors Longitude Capital, Soleus Capital Management, and an undisclosed strategic investor joined the round along with current...
Cordis has announced a strategic investment venture that will expand the scope of the global cardiovascular technology company into the venous thromboembolism (VTE) market with a strategic investment in Endovascular Engineering (E2), a developer of next-generation thrombectomy devices to...
In this issue:
What to expect from CX 2022
A year in profiles: Ali AbuRahma, Michael Jenkins, Joseph Bavaria, and Palma Shaw
Vascular News debuts a brand new column for vascular trainees: Launch Pad
Highlights from the American Venous Forum (AVF)...
In this issue:
What to expect from CX 2022
A year in profiles: Ali AbuRahma, Michael Jenkins, Joseph Bavaria, and Palma Shaw
Vascular News debuts a brand new column for vascular trainees: Launch Pad
Highlights from the American Venous...
Shockwave Medical has announced the global commercial availability of the Shockwave M5+ peripheral intravascular lithotripsy (IVL) catheter after receiving both CE mark and US Food and Drug Administration (FDA) clearance.
A company press release details that the Shockwave M5+...
Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received Breakthrough Device designation from the US Food and Drug Administration (FDA), a press release reports. The Thoraco+ is the second product from Cook Medical to receive a Breakthrough Device designation...
The Janssen Pharmaceutical Companies of Johnson & Johnson recently announced data from new analyses from the Phase 3 VOYAGER PAD clinical trial reinforcing the benefit of the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus aspirin 100mg once daily)...
Nipro Medical Corporation is set to introduce its second-generation Cronus high-pressure (HP) percutaneous transluminal angioplasty (PTA) balloon catheter to the US market.
Cronus HP is indicated for use in popliteal, femoral, iliac, and renal arteries, and in the treatment of...
Janssen has announced the launch of 'Save Legs. Change Lives. Spot Peripheral Artery Disease Now', a multi-year initiative aimed at creating urgency and action to address the hidden threat of peripheral arterial disease (PAD)-related amputation, with an initial focus...
Robert Hinchliffe (University of Bristol, Bristol, UK) shares his excitement to attend the upcoming CX Symposium in April. “CX has always represented an unprecedented opportunity to share new techniques and to analyse the latest and best clinical trials across...
Medtronic recently voluntarily recalled a subset of its IN.PACT Admiral and IN.PACT AV paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential for pouch damage resulting in a loss of sterility. This is according to a news...
NOTE: This video is ONLY available to watch in selected countries and geographies
Gunnar Tepe (interventional radiologist, Germany) discusses the results and subsequent impact of the EMINENT randomised controlled trial on his practice, explaining that the Eluvia stent has...
Ra Medical Systems has announced the achievement of a milestone with the enrollment of 100 subjects in the pivotal clinical study, according to a press release. The study is to evaluate the safety and effectiveness of the DABRA excimer...
Carotid endarterectomy (CEA) does not appear to either reduce or increase the risk of dementia, despite it having been shown to reduce stroke risk. This is according to 20-year results from the ACST-1 trial, published online ahead of print...
Shanghai MicroPort Endovascular MedTech (Endovastec) recently announced that it has received registration approval from Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the Hyperflex Balloon Catheter (Hyperflex) as the company's first product approved for marketing in Japan, according to...
Tractus Vascular recently announced the first-in-man use of the Tractus Crossing Support Catheter (Tractus CSC). The Tractus CSC represents a highly novel approach to treating vascular disease.
Chronic total occlusion (CTO) remains one of the most challenging pathologies encountered by...
In future peripheral arterial disease (PAD) research, clinicians should not consider men and women as a single population and should instead report their data separately. This is the main conclusion of a systematic review and meta-analysis recently published in...
“As vascular surgeons, we never stop learning,” Palma Shaw tells Vascular News. This is one of the key attractions of the specialty for Shaw, who recalls various aspects of her career to date—from her early days learning endovascular surgery...
A retrospective evaluation of 600 fenestrated or branched endovascular aneurysm repairs (F/BEVARs) for the treatment of complex aneurysms revealed that fewer than one in five patients experienced an intraoperative adverse event, according to a press release announcing study results...
NOTE: This video is ONLY available to watch in selected countries and geographies
Koen Deloose (vascular surgeon, Belgium) looks at the evidence needed in order to make the best decision for his patients when treating the superficial femoral artery (SFA)....
Fist Assist Devices has announced a three-year affiliation with Regional Health Care Group to commercialise and launch sales of the Fist Assist Model FA-1 device in Australia and New Zealand.
The FA-1 device is a wearable, patent-protected, intermittent compression...
Enrolment has been completed in the PROMISE II pivotal trial of the LimFlow deep vein arterialisation system (LimFlow SA) designed to prevent amputations in so-called "no-option" chronic limb-threatening ischemia (CLTI) patients, the eponymous device maker announced today.
“The PROMISE II...
Cordis recently announced that the US Food and Drug Administration (FDA) has approved the S.M.A.R.T. Radianz vascular stent system, a self-expanding stent purposefully engineered for radial peripheral procedures.
The newly approved vascular stent system joins the Brite Tip Radianz guiding sheath...
Recently published research indicates that stent grafting with the Viabahn endoprosthesis (W L Gore & Associates) of long and complex superficial femoral artery (SFA) lesions in patients with claudication is a safe and effective long-term treatment option.
Writing in...
The VasQ external support device (Laminate Medical) has demonstrated long-term benefits for radiocephalic (forearm) arteriovenous fistula (AVF) creation in a retrospective analysis of 150 consecutive procedures. Robert Shahverdyan (Asklepios Klinik Barmbek, Hamburg, Germany) and Dirk Hentschel (Brigham and Women’s...
Medtronic has announced that it has entered into a contract with Vizient to add Touch Surgery Enterprise, an AI-powered surgical video management and analytics platform for the operating room (OR), to Vizient's offerings.
In a press release, Medtronic said that...
Cardiovascular Systems Inc (CSI) has announced the start of enrolment in a first in-human trial of the peripheral everolimus drug-coated balloon (DCB) being developed by Chansu Vascular Technologies (CVT).
DCBs are a widely accepted percutaneous interventional treatment option for femoropopliteal...
February's top 10 includes a consensus statement from the Society for Vascular Surgery (SVS) and the Enhanced Recovery after Surgery (ERAS) Society on perioperative care in open aortic surgery, an enrolment update on Concept Medical's SIRONA head-to-head trial of...
InspireMD has announced that its CGuard embolic prevention stent system (EPS) will be included as a device option for stenting in CREST-2 (Carotid revascularisation endarterectomy or stenting trial). Following the recent approval of the CREST-2 investigational device exemption (IDE)...
The US Food and Drug Administration (FDA) recently announced it has issued a letter to healthcare providers emphasising the importance of lifelong surveillance, including imaging, for patients with abdominal aortic aneurysm (AAA) endovascular aneurysm repair (EVAR).
"Regular imaging surveillance, within...
NOTE: This video is ONLY available to watch in selected countries and geographies
Antonio Micari (interventional cardiologist, Italy) gives his thoughts on the EMINENT RCT and whether it may have influenced his decision to use drug-eluting stents and drug...
Johns Hopkins Medicine researchers have developed and tested a new imaging approach they say will accelerate imaging-based research in the lab by allowing investigators to capture images of blood vessels at different spatial scales.
Tested in mouse tissues, the method,...
In this issue:
Population-based data project unmasks “frightening” trends in worldwide vascular disease burden
CX 2022 returns to in-person format, faces challenges and opportunities in the vascular world
Societies take action to address disparities in vascular care
Profile: Palma...
In this issue:
Population-based data project unmasks "frightening" trends in worldwide vascular disease burden
CX 2022 returns to in-person format, faces challenges and opportunities in the vascular world
Societies take action to address disparities in vascular care
Profile: Palma...
Humacyte today announced that five-year data from a phase 2 clinical trial of patients receiving the investigational Human Acellular Vessel (HAV) for arteriovenous (AV) access in haemodialysis have been published in the European Journal of Vascular and Endovascular Surgery companion...
Charing Cross (CX) chair Roger Greenhalgh welcomes the vascular community to this year's symposium, due to be held 26–28 April in London, UK, and virtually. To read the preliminary programme and register visit cxsymposium.com.
Anticipation is building for the Charing Cross International Symposium 2022 (26–28 April, London, UK, in person and virtual), which this year will address some of the key challenges currently facing the vascular field—from the ongoing impact of COVID-19 on...
Cardiovascular Systems Inc (CSI) recently announced it has partnered with Innova Vascular (Innova) to develop a full line of novel thrombectomy devices.
According to a press release, CSI intends to acquire and commercialise novel thrombectomy devices from Innova targeting peripheral vascular...
The Society for Vascular Surgery (SVS) and the Enhanced Recovery after Surgery (ERAS) Society have released a consensus statement intended to help address perioperative challenges faced by vascular surgery patients.
The ERAS pathways have proven beneficial for a number of...
Ra Medical Systems recently announced that enrolment has reached 95 patients in its pivotal clinical trial to evaluate the safety and effectiveness of the Dabra excimer laser system as an atherectomy device for the treatment of peripheral arterial disease...
Front Line Medical Technologies has announced the expanded availability and distribution of COBRA-OS (Control of bleeding, resuscitation, arterial occlusion system), as US and Canadian hospitals continue to implement the aortic occlusion device during various surgical and emergency cases.
The COBRA-OS,...
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Yann Goueffic (vascular surgeon, France) discusses the evidence that is needed for the best treatment strategy of the femoropopliteal segment. He examines a range of stents,...
Researchers have developed a novel method of measuring growth of thoracic aortic aneurysm, which they claim could significantly improve the accuracy and reliability of aortic measurements compared to standard-of-care measurement techniques.
The technique, which is known as vascular deformation mapping,...
Inari Medical has announced that the first patient has been enrolled in PEERLESS prospective, randomised controlled trial (RCT) comparing the outcomes of patients with intermediate-high risk pulmonary embolism (PE) treated with the FlowTriever system versus catheter-directed thrombolysis (CDT).
The first...
An analysis of the worldwide experience of transcarotid artery revascularisation (TCAR) has produced key objective proficiency metrics and an analytic framework to assess adequate training for the procedure. “Training on cadavers or synthetic models achieved clinical outcomes, technical outcomes...
A multicentre, retrospective database analysis suggests improved open abdominal aortic aneurysm (AAA) outcomes when surgeon volume is greater than seven cases yearly and performed in hospitals with a 30-day mortality rate less than 5%.
“Open AAA repair has decreased in...
Concept Medical recently announced that the SIRONA randomised controlled trial (RCT)—a head-to-head comparison of sirolimus versus paclitaxel drug-eluting balloon angioplasty in the femoropopliteal artery—has completed half the targeted enrolment.
According to a company press release, SIRONA is the world’s first...
Royal Philips has announced an update to its handheld ultrasound platform—Lumify—adding Pulse Wave Doppler technology to expand the haemodynamic assessment and measurement capabilities of the system.
In a press release, Philips said that the new functionality would enable clinicians to...
Breakthrough designation for a new drug-eluting stent from Cook Medical, a meta-analysis on the safety of expedited carotid artery surgery vs. expedited stenting after index event, and new aortic and venous guidelines piqued readers' interest in January.
1. Cook Medical...
A new research letter in Stroke outlines use of the novel National Institutes of Health (NIH) ‘All of Us’ research programme dataset of diverse participant data to identify factors that increase the risk of carotid artery stenosis and those...
Regio Biosciences, a Hibiscus BioVentures company, recently announced it has entered into an exclusive license agreement with AstraZeneca to further develop REG-101, a novel therapeutic acting on reverse cholesterol transport. Regio expects to initiate a Phase 2a clinical programme evaluating REG-101...
Black adults born in the USA had a higher rate of death from cardiovascular diseases and all causes compared to Black adults who were born in other countries, according to preliminary research to be presented at the American Stroke Association’s International...
The Vascular Society Amputation Special Interest Group (SIG) recently held a remote UK multi-stakeholder meeting, including surgeons, physiotherapists, prosthetists, orthotists, occupational therapists and rehabilitation consultants, to discuss the place of through-knee amputation (TKA) surgery in today's vascular practice. Robert...
MedAlliance has acquired its partner MDK Medical, a Japanese vascular specialist company. MDK Medical has previously worked closely with MedAlliance in developing Japanese clinical studies for its novel sirolimus drug-eluting balloon (DEB) Selution SLR in the treatment of peripheral...
RapidAI has announced Karim Karti, former president and CEO of GE Healthcare Imaging, as the company’s chief executive officer (CEO).
“Karim’s tremendous global experience in healthcare technology and digital health makes him an ideal fit for RapidAI. He has a...
Humacyte today announced results from the first series of compassionate use cases of the company’s investigational Human Acellular Vessel (HAV) for the treatment of chronic limb-threatening ischaemia (CLTI) and vascular trauma.
The HAVs were observed to remain patent and infection...
This advertorial is sponsored by NovaSignal.
Liverpool Heart and Chest Hospital (LHCH) has become the first European heart centre to purchase NovaSignal’s NovaGuide—a new, autonomous robotic transcranial Doppler (TCD) system for perioperative monitoring. The device was purchased by the Liverpool...
The US Food and Drug Administration (FDA) has issued two final guidances providing recommendations for including patient perspectives in medical device clinical studies.
As per an FDA press release, the finalised version of the first of these two guidance...
A systematic review and meta-analysis of 71 studies suggests that, at present, carotid endarterectomy (CEA) is safer than carotid artery stenting (CAS) when performed within two or seven days of the index event. “The findings of this analysis will...
A review evaluating the results of thoracic endovascular aortic repair (TEVAR) following acute type B aortic dissection suggests most patients with acute type B aortic dissection have less than 2cm of proximal healthy descending thoracic aorta. In patients treated...
New clinical practice guidelines have been published today, and are intended to act as “guard rails” to determine the treatment options and best practices for managing patients with type B aortic dissection. An important update in the document is...
CytoSorbents has called attention to a new publication which reports on the use of intraoperative haemoadsorption using the company's technology to reduce perioperative bleeding complications in patients with acute type A aortic dissection who were either on the direct...
Concept Medical has shared the latest update from its IMPRESSION (Sirolimus-coated balloon angioplasty versus plain balloon angioplasty in the treatment of dialysis access dysfunction) randomised controlled trial (RCT), as it crosses the 50% enrolment mark.
The IMPRESSION trial enrolled its...
Veryan Medical has confirmed the release of MIMICS-3D EU three-year results by the study principal investigator Michael Lichtenberg (Vascular Center Arnsberg, Klinikum Hochsauerland, Arnsberg, Germany) at this year’s International Symposium on Endovascular Therapy (ISET 2022; 16–19 January, Hollywood, USA)....
Cook Medical has received Breakthrough Device designation from the US Food and Drug Administration (FDA) on a new drug-eluting stent for below the knee (BTK). This new stent is designed to treat patients suffering from chronic limb-threatening ischaemia (CLTI).
“CLTI...
According to the US Food and Drug Administration (FDA), Medtronic is recalling its HawkOne directional atherectomy system.
The FDA has identified the recall as a Class I—the most serious type in that “use of these devices may cause serious injuries...
Pathfinder Medical, which has developed a proprietary technology to guide and accurately align catheters in endovascular procedures allowing clinicians to make connections across blood vessels in the body without the need for open surgery, has announced securing £8.5 million.
The...
BD has announced the launch and US Food and Drug Administration (FDA) 510(k) clearance for the Crosser iQ chronic total occlusion (CTO) recanalisation system, which is designed to cross peripheral artery CTOs intraluminally.
The Crosser iQ ultrasonic CTO device was...
A new study reports that watching TV for four hours a day or more is associated with a 35% higher risk of venous thromboembolism (VTE) compared with less than 2.5 hours. The research is published today in the European...
The European Society for Vascular Surgery (ESVS) has released 2022 clinical practice guidelines on the management of chronic venous disease (CVD) of the lower limbs to update its 2015 recommendations. The document, authored by Marianne G De Maeseneer (Erasmus...
Said Abisi (London, UK) talks to Vascular News about the various treatment options for peripheral arterial disease (PAD) patients with severely calcified lesions, including plain percutaneous transluminal angioplasty (PTA), stenting or atherectomy. “None of these come without risk” notes...
CryoLife announced that it was renaming and rebranding itself to Artivion, effective immediately. Derived from the words "aorta", "innovation", and "vision", the company's new name and brand reflect its evolution to focus on providing innovative technologies to surgeons who...
Findings from a first-of-its-kind study conducted at University Hospitals (UH) Harrington Heart & Vascular Institute (Cleveland, USA) showed a novel system-wide interdisciplinary team assembled to evaluate alternative treatments to major amputation improved outcomes for patients with chronic limb-threatening ischaemia...
Ajax Health has announced the appointments of two cardiovascular professionals to Cordis-X, an independent accelerator created to drive innovation and growth to Cordis.
"Since the acquisition of Cordis almost a year ago, we have made substantial investments in R&D, M&A,...
Royal Philips today announced physicians will now have access to advanced new 3D image guidance capabilities through its image-guided therapy mobile C-arm system—Zenition. The system will deliver enhanced clinical accuracy and efficiency, according to Philips, and aims to improve...
Cardiovascular Systems recently announced that it has made significant progress towards the commercialisation of intravascular lithotripsy (IVL) systems for the treatment of calcific coronary and peripheral arterial disease.
A press release notes that feasibility testing of a proprietary console and...
The US investigational device exemption (IDE) Aortic Research Consortium has produced the strongest data so far on the use of fenestrated/branched endovascular aneurysm repair (F/BEVAR), Andres Schanzer (University of Massachusetts, Worcester, USA) claimed at Critical Issues in Aortic Endografting...
Today, the US Food and Drug Administration (FDA) issued an updated safety communication on the use of Endologix AFX endovascular grafts. This update includes a summary of information from a November 2021 meeting of the FDA's Circulatory System Devices...
The European Society for Vascular Surgery (ESVS) has released 2022 clinical practice guidelines on the management of chronic venous disease (CVD) of the lower limb to update its 2015 recommendations. The document, authored by Marianne G De Maeseneer (Erasmus...
Transit Scientific recently announced that its XO Cross platform has been successfully used in challenging peripheral vascular procedures.
A press release details that Jihad Mustapha, interventional cardiologist at Advanced Cardiac & Vascular Center in Grand Rapids, USA, has performed several...
Highlights from the UK Vascular Societies’ Annual Scientific Meeting (VSASM 2021; 1–3 December, Manchester, UK), a VOYAGER PAD subanalysis, and Cordis' appointment of a new CEO caught readers' attention in December.
1. VOYAGER PAD subanalysis highlights risks for claudicants undergoing...
In response to a rapid augmentation of social media use in medicine over the past five years, the Society for Vascular Surgery (SVS) has published a set of recommendations on appropriate practice. The document aims to provide guidance on...
A cost-effectiveness model based on peer-reviewed sources suggests that although five-year costs for transcarotid artery revascularisation (TCAR; Silk Road Medical) were higher than those for carotid endarterectomy (CEA), TCAR afforded greater quality-adjusted life years (QALY).
The study is published in the...
MolecuLight announced today that SWK Holdings has provided US$10 million structured debt to support MolecuLight’s global commercial expansion.
SWK Holdings Corporation is a life science focused specialty finance company catering to small- and mid-sized commercial-stage companies through the creation of...
Upstream Peripheral Technologies announced today that its GoBack catheter for crossing and re-entry was proven very effective for patients undergoing complex revascularisations in lower limb arteries. The findings are based on a peer-reviewed study published in the Journal of...
Fist Assist Devices has announced that it recently received Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Fist Assist Model FA-1 device.
According to the company, the FA-1 is the world’s first wearable device for...
Research indicates that healthcare professionals perform better than risk prediction tools at predicting 30-day mortality, morbidity, and revision risk in patients following major lower limb amputation. The PERCEIVE study is led by chief investigator David Bosanquet (Royal Gwent Hospital,...
Emma Hardy, UK Member of Parliament (MP) for Hull West and Hessle and chair of the All-Party Parliamentary Group on Vascular and Venous Disease, outlines pilot efforts steered by National Health Service (NHS) England and the National Wound Care...
The Society of Thoracic Surgeons (STS) has appointed Joanna Chikwe (chair of the Department of Cardiac Surgery in the Smidt Heart Institute at Cedars-Sinai, Los Angeles, USA) as the new editor-in-chief of The Annals of Thoracic Surgery and its...
Alexandros Mallios (Paris, France) and Robert Shahverdyan (Hamburg, Germany) talk to Vascular News about some of the benefits of the Ellipsys™ Vascular Access System (Medtronic), how it compares to more traditional fistula creation techniques, and the key steps for...
Principal investigator of the VOYAGER PAD trial, Marc Bonaca (University of Colorado Anschutz Medical Campus, Aurora, USA) speaks to Vascular News about the latest data from the study, which indicate that patients with claudication are at high risk for adverse...
The new Vascular Society of Great Britain and Ireland (VSGBI) president Jonathan Boyle (Cambridge, UK) speaks to Vascular News about his plans for the coming year. The promotion of key messages in the newly published Provision of Services for People with...
Cleaning and low-level disinfection (LLD) effective against bloodborne pathogens are safe and sufficient procedures for disinfecting ultrasound transducers used in percutaneous procedures—this is according to an intersocietal position statement recently issued by the American Institute of Ultrasound in Medicine...
Terumo Aortic has announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval of the RelayPro thoracic stent graft system for sale in Japan for the treatment of patients with thoracic aortic aneurysms (TAAs).
RelayPro is a...
Cordis has announced George Adams as chief medical officer.
"We are delighted to have Dr Adams join our team as we continue to build the new Cordis," said CEO Shar Matin. "His depth of expertise in the treatment of both complex...
November's top 10 features a large-scale analysis of Philips' intravascular ultrasound (IVUS) in lower extremity peripheral vascular interventions, five-year data on Avenu Medical/Medtronic's Ellipsys vascular access system, and highlights from the 2021 VEITHsymposium (16–20 November, Orlando, USA).
1. Philips IVUS...
Research indicates that plasma desmosine has the potential to act as a biomarker of acute aortic syndrome and could, in the future, be used as a diagnostic tool for the condition in the acute setting. Presenting the findings of...
Terumo Aortic has announced the launch and first commercial case of the Aortic Balloon in the USA. The device assists physicians in the expansion of the aorta when using Treo and Relay stent grafts in endovascular aortic repair, a...
A team led by investigators at Massachusetts General Hospital (MGH) in Boston, USA, recently used deep learning to uncover insights into the genetic basis for variation in the size of the aorta. In addition to identifying at-risk individuals, the...
A large-scale analysis of the use of Philips' intravascular ultrasound (IVUS) in lower extremity peripheral vascular interventions adds “meaningful data” to a growing pool of evidence advocating the continued use of the imaging methodology, Eric A Secemsky (Beth Israel...
Alio has announced a partnership with Lifeline Vascular Care in support of patients living with end-stage renal disease (ESRD). Alio leverages artificial intelligence (AI) and the company’s SmartPatch sensor technology to non-invasively monitor vascular access health and other chronic...
The Amplifi Vein Dilation System (Artio Medical) is is an innovative device designed to dilate arm veins in preparation for AVF surgery using rapid, non-pulsatile venous blood flow. Surendra Shenoy, M.D. (a vascular surgeon with specialist interest in vascular...
Artio Medical has announced that full results from its first-in-human clinical study of the Amplifi vein dilation system were presented at the 2021 VEITHSymposium (16–20 November, Orlando, USA and virtual) by Surendra Shenoy, associate professor of surgery in the Washington University School...
Soundbite Medical Solutions has announced that the US Patent and Trademark Office has issued a patent to a device for delivering high amplitude broadband mechanical pulses to treat a lesion present in a blood vessel.
The device includes a catheter...
Aopeng Medical’s Allvas endovascular intervention surgical robot has successfully completed a first-in-human clinical evaluation of robot-assisted peripheral artery intervention of an iliac artery in the Department of Vascular Surgery at Shanghai Changhai Hospital.
The procedure was performed by Qing-Sheng Lu and colleagues in the Department of Vascular Surgery at Shanghai Changhai Hospital in Shanghai, China. The endovascular intervention surgical robot, combined with...
Canon Medical Systems is introducing an all-new size for its high-definition flat panel detector for vascular and interventional radiology (IR) procedures, a press release from the company reports. Canon Medical claims that the 12”×16” high-definition detector provides more than twice the spatial resolution of conventional flat panel detectors, helping clinicians...
“Go for it!” Michael Jenkins urges anyone looking to start a career in medicine, highlighting that the COVID-19 pandemic has put into sharp focus its “vocational and worthwhile nature”. Over the course of his own career to date, Jenkins...
Endologix has completed enrolment in the TORUS 2 investigational device exemption (IDE) clinical study in the USA, a press release reports.
The TORUS 2 study is a prospective, single-arm trial of 188 patients to evaluate safety and effectiveness of...
Shockwave Medical has announced the start of the Disrupt BTK II postmarket study to assess the safety, effectiveness and optimal clinical use of the Shockwave peripheral intravascular lithotripsy (IVL) system for the treatment of calcified peripheral lesions below the...
“I think this represents the beginning of the end of an era where we have to use lead to perform these procedures.” Those were the words delivered by Gustavo Oderich, professor and chief of vascular and endovascular surgery at...
The Minneapolis Heart Institute Foundation (MHIF; Minneapolis, USA) has announced the publication of research showing improved patient outcomes and significantly decreased 30-day mortality in aortic dissection patients managed through a unique comprehensive care strategy designed by a team with...
Isabelle Van Herzeele (Ghent, Belgium) and Adrien Hertault (Valenciennes, France) speak about the importance of face to face training sessions for trainee physicians and physicians in practice. The pair tells Vascular News at the Paris Vascular Insights meeting (21–23 October...
Artificial intelligence (AI) will transform the accuracy of patient selection and endograft selection for aortic procedures. Its use will shore up computed tomography (CT) scan analysis and comparison, not just when tracking maximum aortic diameters at the various segments...
A recent study has pointed to an increased risk of stroke in both asymptomatic and symptomatic female patients, as well as readmission in asymptomatic female patients following carotid endarterectomy (CEA) or carotid artery stenting (CAS). These findings were published...
Avinger recently announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for a new clinical indication for the Pantheris image-guided atherectomy system. This clearance allows the company to directly market Pantheris for the...
The confirmatory EVAS2 clinical study to evaluate the safety and effectiveness of the Nellix endovascular aneurysm sealing system (EVAS; Endologix) for the treatment of infrarenal abdominal aortic aneurysms (AAAs) contains positive two-year follow-up data, the leading investigator has revealed.
A...
Viz.ai has announced the US commercial launch of its AI-powered modules for pulmonary embolism and aortic disease. Debuting at VEITHsymposium 2021 (16–20 November, Orlando, USA), the new modules allow for faster clinical decision making and improved care coordination for patients suffering...
Bentley has announced that on-label use of the company's BeGraft peripheral balloon-expandable covered stent in complex aortic aneurysms is a step closer with more than 50 patients now enrolled in the fenestrated endovascular aneurysm repair (FEVAR) study, which is...
In a pooled analysis of the predictors of drug-coated balloon (DCB) effectiveness, the IN.PACT Admiral DCB (Medtronic) performed well across a broad range of clinical, anatomical, and procedural scenarios. This is according to Prakash Krishnan (Mount Sinai Hospital, New...
Endologix has announced the appointment of Matthew Thompson as president and chief executive officer. Thompson will also join Endologix’s board of directors. Richard Mott, who previously held the CEO position on an interim basis, will return to his role...
New data from a head-to-head, randomised trial comparing vascular closure devices, highlights from CX Aortic Vienna 2021 (5–7 October, broadcast) and an interview with past Society of Thoracic Surgeons (STS) president Joseph E Bavaria (Philadelphia, USA) caught readers’ attention in October.
1....
The Ellipsys vascular access system (Avenu Medical/Medtronic) can be used to easily and safely create durable percutaneous arteriovenous fistulas (pAVFs) for haemodialysis—with new, long-term data suggesting it offers an “excellent alternative” to AVF creation via surgical procedures in end-stage...
Royal Philips today announced the results of a new large-scale, real-world analysis of Centers for Medicare & Medicaid Services (CMS) data on the health outcomes of peripheral vascular interventions guided by intravascular ultrasound (IVUS).
The study was conducted independently by...
Hispanic adults hospitalised for treatment of symptoms of peripheral arterial disease (PAD) were more likely to access this care by going to the emergency room (ER), and they experienced longer and more expensive hospitalisations than non-Hispanic white patients with...
Medtronic has announced its ambition to achieve net zero carbon emissions by fiscal year 2045 across its operations and value chain to accelerate efforts to combat climate change. The announcement comes amidst the 2021 United Nations Climate Change Conference...
A trio of specialists in vascular surgery and interventional radiology recently launched a new podcast—‘Masters of Circulation’—with the aim of interviewing pioneers and leaders in the field of vascular intervention.
The podcast team consists of Ramon Varcoe, vascular surgeon...
Medtronic today announced findings from a new study of patient preferences for the treatment of hypertension. The findings are set to be presented during the “What's Novel in Interventional Hypertension” session at the 33rd Transcatheter Cardiovascular Therapeutics annual meeting (TCT...
Shockwave Medical has announced that, as part of the calendar year 2022 Medicare Hospital Outpatient Prospective Payment System (OPPS) final rule, the Centers for Medicare and Medicaid Services (CMS) has reassigned the payment for peripheral intravascular lithotripsy (IVL) procedures...
A research team led by Lim Chwee Teck from the National University of Singapore’s (NUS; Singapore) Department of Biomedical Engineering and Institute for Health Innovation & Technology (iHealthtech), in collaboration with clinical partners from Singapore General Hospital (Singapore), has...
The SARS-CoV-2 virus does not infect blood vessels, despite the high risk of blood clots to COVID-19 patients, University of Queensland (UQ) researchers have found.
Emma Gordon and Larisa Labzin from UQ’s Institute for Molecular Bioscience and Kirsty Short from UQ’s School of Chemistry and Molecular...
Argon Medical Devices has announced the launch of two portal vein access sets intended for transjugular liver access in diagnostic and interventional procedures.
The Scorpion portal vein access series addresses the common challenges physicians encounter when placing a transjugular intrahepatic...
Transit Scientific has announced US Food and Drug Administration (FDA) clearance of new hydrophilic-coated XO Cross microcatheters for guidewire support, exchange, and contrast media injection in the peripheral vasculature.
“The XO Cross devices deliver unique performance and control that make...
Marie Lannelongue Hospital of Paris Saint-Joseph Hospital Group (Paris, France) and Incepto, a European specialist in artificial intelligence (AI) applied to the medical field, recently announced the creation of ARVA (Augmented radiology for vascular aneurysm), a novel solution for...
Twelve-month results from a first-in-human study of the Wrapsody cell-impermeable endoprosthesis (Merit Medical Systems) for the treatment of access circuit stenosis in haemodialysis patients are “very encouraging”. This is according to James Gilbert, a consultant transplant and vascular access...
This educational supplement is only available in selected countries and geographies.
In this supplement:
Said Abisi (Guy’s and St Thomas’ NHS Foundation Trust, London, UK) outlines the reasons why inner branched endovascular aneurysm repair (iBEVAR) “serves as a valuable...
Newly-installed American College of Surgeons (ACS) president Julie A Freischlag (Wake Forest Baptist Health, Wake Forest School of Medicine, Winston-Salem and Atrium Health Enterprise, USA) called for her fellow surgeons to apply the principles that underpin enhanced recovery as...
At Paris Vascular Insights (PVI) 2021 (21–23 October, Paris, France), Peter Schneider (University of California San Francisco, San Francisco, USA) emphasised the need for trainees to learn both open and endovascular techniques in a talk on how to remain...
In this issue:
Next generation of vascular surgeons need open and endovascular skills
Head-to-head trial shows superiority of FemoSeal over ProGlide for peripheral interventions
Conference coverage: Data and insights from CX Aortic Vienna, Vascular Interventional Advances (VIVA), Paris Vascular...
In this issue:
Next generation of vascular surgeons need open and endovascular skills
Head-to-head trial shows superiority of FemoSeal over ProGlide for peripheral interventions
Conference coverage: Data and insights from CX Aortic Vienna, Vascular Interventional Advances (VIVA), Paris Vascular...
Researchers have observed an increased frequency of chromosomal aberrations in endovascular operators that is likely to be related to occupational radiation.
Speaking in the Prize Session at this year’s European Society for Vascular Surgery (ESVS) annual meeting (28–29 September, Rotterdam,...
Patients who survive an aortic dissection often fail to receive comprehensive post-surgical follow-up care leaving them vulnerable to a lifetime of sustained risk. This is according to research published in the Journal of the American College of Cardiology (JACC), authored by Jennifer Chung (Peter Munk Cardiac Centre,...
One of the biggest challenges for education in the wake of COVID-19, writes Celia Riga (Head of London School of Surgery, HEE), is integrating service and training priorities whilst managing a “significant” care backlog. In order for this to...
Results of the randomised, prospective, multicentre STEP trial show that the FemoSeal vascular closure system (Terumo) is superior to the Perclose ProGlide suture-mediated closure system (Abbott) in peripheral arterial disease (PAD) patients in terms of technical success using a...
An investigational device invented at Sanford Health (Sioux Falls, USA) that helps high-risk vascular disease patients has been granted a Breakthrough Device designation by the US Food and Drug Administration (FDA).
Patrick Kelly, a Sanford Health vascular surgeon, invented the...
A retrospective study supports the use of the Wound, ischaemia, and foot infection (WIfI) classification system to predict the revascularisation benefit for diabetic patients with chronic limb-threatening ischaemia (CLTI).
The WIfI classification system was developed to stratify the risk of...
Following the recent approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) of the Treo abdominal aortic stent graft system for sale in Japan for the treatment of patients with abdominal aortic aneurysm (AAA), Terumo Aortic recently announced...
Quanta Dialysis Technologies announced today the results of the UK Dialysis Patient Experience Survey, showing the wide variance in care experienced by UK dialysis patients, as well as challenges faced in assessing self-care and home haemodialysis (HHD).
The survey revealed:
...
“We are at the beginning of a type A dissection revolution,” Joseph E Bavaria (University of Pennsylvania, Philadelphia, USA) told attendees at London Aorta 2021 (16–17 September, London, UK). In a keynote lecture, Bavaria charted the history of type...
In this penultimate episode of a special five-part series on the history of drug-coated balloons (DCBs), Jos van den Berg (Lugano, Switzerland) is joined by Gunnar Tepe (Rosenheim, Germany) and Thomas Zeller (Bad Krozingen, Germany), with the trio discussing...
In support of the Legs Matter Campaign’s awareness week (11–15 October), Sam Everington, a GP at the Bromley by Bow Centre in London, UK, and former British Medical Association (BMA) chair, is calling on GPs, pharmacists and other primary...
MolecuLight has announced the launch of the MolecuLightDX, a new point-of-care device model targeted at the needs of new expanding wound care market segments in the USA. The DX is an expansion of MolecuLight’s product line and compliments the...
“I would say that the future is incredibly bright for cardiovascular surgeons,” Joseph E Bavaria tells Vascular News. The 52nd president of the Society of Thoracic Surgeons (STS), Bavaria first studied engineering before pursuing a career in cardiovascular surgery,...
LimFlow SA has announced 24-month results from the PROMISE I study of the LimFlow percutaneous deep vein arterialisation system, confirming "excellent and sustained outcomes" for both amputation-free survival and wound healing, a press release reports. The late-breaking data were...
Eighteen-month results from the PRESTIGE below-the-knee (BTK) study were presented as a late-breaking clinical trial at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA). The objective of this clinical investigation is to evaluate safety and performance outcomes of Selution SLR...
Boston Scientific announced positive results for the EkoSonic endovascular system (EKOS system) during a late-breaking clinical trial presentation at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA). Data from the KNOCOUT PE registry—established to measure institutional adoption...
Preliminary clinical results from a first-in-human study assessing the Amplifi vein dilation system (Artio Medical) were presented at Vascular Interventional Advances (VIVA) 2021 (5–7 October 2021, Las Vegas, USA). Data were presented by Surendra Shenoy—an associate professor of surgery at...
Real-world data drawn from the IN.PACT Global study looking at five-year freedom from clinically-driven target lesion revascularisation (TLR) among prespecified chronic total occlusion (CTO), long lesion and de novo in-stent restenosis (ISR) cohorts “continues to confirm long-term clinical safety...
Patients treated with the Ranger drug-coated balloon (DCB; Boston Scientific) sustained “improved primary patency” with fewer reinterventions than those treated with uncoated devices, two-year results from the RANGER II SFA randomised controlled trial have demonstrated, investigators revealed during a...
An interim analysis from the DISRUPT PAD III observational study showed that intravascular lithotripsy (IVL; Shockwave Medical) performs “consistently well” across challenging peripheral vessels, lesions and subgroups of patients, Ehrin J Armstrong, medical director at Adventist Heart and Vascular...
Several subgroups of patients treated with the IN.PACT AV drug-coated balloon (DCB; Medtronic) for arteriovenous fistulas (AVFs) demonstrated a “statistically significant” higher rate of target lesion primary patency (TLPP) compared to those who underwent standard percutaneous transluminal angioplasty (PTA)...
One-year results presented at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA) from the EMINENT trial demonstrated the superiority of the Eluvia drug-eluting stent (DES) system (Boston Scientific) compared to self-expanding bare metal stents for the treatment...
BD recently announced it has received 510(k) clearance for expanded indications from the US Food and Drug Administration (FDA) for the Rotarex atherectomy system.
The Rotarex atherectomy system is a rotational excisional device that is built to remove and aspirate...
The ever-changing subject of aortic arch and thoracoabdominal treatment was addressed at CX Aortic Vienna 2021 (5–7 October, broadcast), with input from speakers and audience participation from across the globe. Edited cases and presentations from The Netherlands, France, Australia,...
Building and maintaining expertise in both open and endovascular surgical techniques will play an important role in training the next generation of surgeons in order to optimise outcomes in patients with aortic disease. This is among the messages to...
ReCor Medical has announced that its Paradise ultrasound renal denervation system is now available for the treatment of uncontrolled hypertension in Germany. The first hospitals performing the procedure commercially are Heart Center Leipzig, Leipzig and Saarland University Hospital, Homburg/Saar.
“Despite...
The specialist aortic team from San Raffaele Hospital (Milan, Italy), led by Roberto Chiesa, gave global CX Aortic Vienna 2021 (5–7 October, broadcast) attendees expert insights into their patient-centric approach to thoraco-adbominal aortic aneurysm (TAAA) reconstruction, encompassing both open...
In a session on “Reduction of radiation challenges” at CX Aortic Vienna 2021 (5–7 October, broadcast), experts highlighted new technologies with the potential to make aortic surgical procedures simpler and shorter, thereby reducing radiation exposure to patients and care...
A poll conducted at CX Aortic Vienna 2021 (5–7 October, broadcast) saw an overwhelming majority of attendees vote in favour of staging endovascular thoracoabdominal aortic aneurysm (TAAA) repair procedures to reduce the rate of spinal cord ischaemia (SCI), a...
Following an edited case demonstrating use of the candy plug technique for false lumen occlusion, presented by Fiona Rohlffs (Hamburg, Germany), an 80% majority of CX Aortic Vienna 2021 (5–7 October, broadcast) attendees stated that they too would deploy...
As evidence builds on the importance of reducing the risk of stroke by removing residual air prior to thoracic endovascular aortic repair (TEVAR) procedures, the onus will be on surgeons and device manufacturers to minimise this risk—as per a...
A worldwide committee of 40 cross-speciality medical experts achieved the first-ever consensus for the appropriate use of intravascular ultrasound (IVUS) in peripheral vascular disease (PVD) interventions.
Global experts conducted a systematic and comprehensive review of key clinical IVUS scenarios and...
Thought-provoking presentations, debate and polling during the first day of CX Aortic Vienna 2021 (5–7 October, broadcast) have shed light on important considerations for the treatment of juxtarenal aortic neck challenges.
During the session, participants unanimously backed use of the...
A decisive vote at CX Aortic Vienna 2021 (5–7 October, broadcast) revealed that 90% of the audience was in favour of offering patients a choice between open and endovascular surgery for aortic arch procedures. Edited cases from Thomas Gandet...
Results of a poll conducted at CX Aortic Vienna 2021 (5–7 October, broadcast) indicated that open procedures have their place in treating the hostile anatomy of the aortic arch, with 100% of voters expressing the opinion that the open...
September's top 10 features five-year ACST-2 results, a new tool to assess amputation risk following popliteal vascular injury, and an interview highlighting the questions still to be answered regarding renal denervation in the treatment of hypertension.
1. Five-year ACST-2 results:...
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In this case report, Panagiotis M Kitrou (Patras University Hospital, Patras, Greece) proposes vessel preparation...
Cardiovascular Systems recently announced that the first patient has been successfully treated with its ViperCross peripheral support catheter.
Billy J Kim (The Surgical Clinic, Nashville, USA), treated the first patient with ViperCross.
Kim remarked: “ViperCross offers the right balance of support...
Siemens Healthineers has launched the Luminos Impulse fluoroscopy system, including features such as a seamless imaging chain, comprehensive dose optimisation, cybersecurity features, and detector-sharing capabilities for radiography.
In a press release, Siemens Healthineers said that the fully digital Luminos...
The Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI), a non-profit organisation dedicated to improving vascular quality within hospitals and outpatient facilities, has announced its partnership with Symmetric Health Solutions, for the purpose of elevating the consistency and integrity...
Surmodics today announced the successful first clinical uses of the Sublime radial access 0.018 RX percutaneous transluminal angioplasty (PTA) dilatation catheter.
Ankur Lodha, perfomed the first procedures with the device at Cardiovascular Institute of the South’s office-based catheterisation lab in...
Endologix today announced that the first patient has been enrolled in the company’s JAGUAR study to compare outcomes for the Alto abdominal stent graft system to other commercially available endovascular aneurysm repair (EVAR) devices for the treatment of abdominal...
Medtronic today announced it has received CE mark approval for its radial artery access portfolio, which includes the Rist radial access selective catheter and the Rist 079 radial access guide catheter—the first catheter specifically designed for the unique demands of accessing...
Biotronik has announced the first patient enrolment in the BIONETIC-I study of the safety and efficacy of the Dynetic-35 cobalt chromium balloon-expandable stent system for the treatment of atherosclerotic peripheral arterial disease (PAD) lesions in the iliac arteries. The...
Capturing the latest developments in the comprehensive treatment of aortic disease—from the aortic valve to the iliac arteries—CX Aortic Vienna returns for three days of CME-accredited discussion and debate, bringing together the cardiac, vascular and endovascular worlds. With a...
In this issue:
Five-year ACST-2 results: Carotid artery surgery and stenting have similar long-term effects on stroke (p. 1)
Coverage of the Society for Vascular Surgery’s Vascular Annual meeting (SVS VAM 2021; 18–21 August, San Diego and online), including...
In this issue:
Five-year ACST-2 results: Carotid artery surgery and stenting have similar long-term effects on stroke (p. 1)
Coverage of the Society for Vascular Surgery's Vascular Annual meeting (SVS VAM 2021; 18–21 August, San Diego and online), including...
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This advertorial, sponsored by BD, is intended for readers in the EMEA region only.
Rethink fistula creation and maintenance with Tobias Steinke, Ounali Jaffer, Panagiotis Kitrou and...
Gore has announced the EMEA launch of the lower profile, large diameter Viabahn endoprosthesis with Propaten bioactive surface.
The device enhancements build on a market-leading stent graft device, which has become an important tool for treating complex vascular disease, Gore...
Despite an older dialysis population, the proportion and survival of arteriovenous fistulas (AVFs) in Danish dialysis patients has not changed over a 39-year period. This is the main conclusion of a national cohort study published online in The Journal...
Biotronik is proud to announce the completion of enrolment of the investigator-initiated BIOPACT randomised controlled trial (RCT). This non-inferiority study evaluates the safety and efficacy of paclitaxel drug-coated balloons (DCBs), comparing the Biotronik Passeo-18 Lux paclitaxel-releasing percutaneous transluminal angioplasty...
A collaborative effort is needed to establish and adhere to best practice guidelines for radiation safety and exposure, Jasmine Bhinder (University at Buffalo, Buffalo, USA) told attendees of the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021;...
A large, multicentre cohort study provides a simple, practical method to effectively stratify patients preoperatively into low- and high-risk major amputation categories.
According to lead author Leigh Ann O’Banion (University of California, San Francisco, San Francisco, USA), “traumatic popliteal artery...
Terumo Aortic has announced the launch of the company’s global surgical graft study known as PANTHER. This study is a prospective and retrospective, multicentre, multi-arm, postmarket study of the company’s range of knitted and woven surgical grafts and cardiovascular...
Terumo Aortic has announced the successful implantation of the company’s first custom-made thoracoabdominal hybrid device to treat thoracoabdominal aortic disease.
The world’s first thoracoabdominal repair procedure using a hybrid open stent graft was carried out by Sebastian Debus and supported...
Today, Boston Scientific announced an agreement to acquire Devoro Medical, developer of the Wolf thrombectomy platform. The non-console and lytic-free Wolf technology targets and captures blood clots using finger-like prongs that retrieve and remove thrombi in the arterial and...
MedAlliance, with its Japanese partner MDK Medical, has completed enrolment in the clinical study of its novel sirolimus drug-eluting balloon (DEB), Selution SLR, for the treatment of peripheral arterial disease (PAD). This follows the acceptance of a Clinical Trial...
Merit Medical Systems has announced positive results from a prospective, observational, first-in-human study to evaluate the safety and effectiveness of Wrapsody—a self-expanding, cell-impermeable endoprosthesis designed for the treatment of arteriovenous (AV) fistula access circuit stenosis and AV graft access...
Bluegrass Vascular Technologies (Bluegrass Vascular) announced today that the Centers for Medicare & Medicaid Services (CMS) has finalised a new Healthcare Common Procedure Coding System (HCPCS) code and New Technology Ambulatory Payment Classification (APC) assignment for use of the...
Following the release of the European Society of Hypertension’s (ESH’s) updated position paper on renal denervation Konstantinos Tsioufis, professor of Cardiology at the University of Athens, Athens, Greece and immediate past president of ESH, discusses the use of renal...
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Bruno Migliara (Peschiera del Garda, Italy) talks to Vascular News about the reasons why bypass failure, which he notes is “really dangerous for life and limb”, is so...
Following the recent approval by the US Food and Drug Administration (FDA) of the RelayPro thoracic stent graft system for the treatment of patients with fusiform and saccular aneurysms, and penetrating atherosclerotic ulcers (PAUs) in the descending thoracic aorta,...
Transcarotid artery revascularisation (TCAR; Silk Road Medical) may be associated with favourable in-hospital outcomes for the treatment of restenotic carotid lesions after carotid endarterectomy (CEA)—following a study that also evaluated in-hospital outcomes of transfemoral carotid artery stenting (TFCAS) and...
Biotronik has announced the expansion of the Fortress reinforced introducer sheath line, which is now available in 7- and 8Fr-compatible sizes in the USA and countries that recognise European CE mark approval.
The Fortress introducer sheaths are intended to provide access...
European Society of Hypertension (ESH), the leading hypertension (HTN) society in Europe, presented an updated position paper on renal denervation (RDN) during the eighth pre-ESH congress satellite symposium (10–11 September; Athens, Greece). The paper was recently published in the...
Luca Bertoglio (Milan, Italy) moderates a Vascular News roundtable on the new E-nside TAAA stent graft system (CryoLife) which has been designed for the treatment of thoracoabdominal aneurysms and uses inner branch technology. Bertoglio is joined by Vladimir Makaloski...
Four-dimensional (4D) flow magnetic resonance imaging (MRI) has the potential to identify patients with a higher risk of severe complications from aortic degeneration according to research published in JACC: Cardiovascular Imaging. The study employed a 4D flow MRI heatmap...
A recent study revealed that endovascular repair of complex aortic aneurysms using fenestrated and branched endografts provides a safe and effective alternative to open surgical repair, with the lowest ever reported mortality rate in this patient population. This is...
Nectero Medical Inc has announced the closing of its US$19.5 million Series C financing round, led by new investor Boston Scientific Corporation. Proceeds will support the company's in vivo and clinical trials to develop a potentially disruptive treatment platform that...
Research presented at the Society for Vascular Surgery’s Vascular Annual Meeting (SVS VAM 2021; 18–21 August, San Diego, USA and online)—including new VOYAGER PAD data, five-year STABLE II results, and the first ever analysis of transcarotid artery revascularisation (TCAR)...
Medtronic has announced CE mark approval and the European launch of the 200mm and 250mm IN.PACT Admiral drug-coated balloons (DCBs). The product is intended to treat long complex femoropopliteal lesions efficiently in patients with peripheral arterial disease (PAD). The...
A Singapore team of scientists and clinicians from Nanyang Technological University, Singapore (NTU Singapore) and Tan Tock Seng Hospital (TTSH), have developed a three-dimensional (3D) model of the human artery blood vessel wall. Called an “arterial wall-on-a-chip”, it will...
R3 Vascular has reported the successful initiation of its first-in-human clinical study evaluating the technical and clinical performance of the R3 Vascular Magnitude bioresorbable sirolimus-eluting scaffold (BRS) in patients suffering of chronic limb-threatening ischaemia (CLTI) due to occlusive below-the-knee...
Results of a database review of more than 500,000 abdominal aortic aneurysm (AAA) repairs revealed the majority of patients treated for rupture did not meet the criteria for aneurysm screening. These findings were reported in the August 2021 issue...
Abbott announced today that it has acquired Walk Vascular, a commercial-stage medical device company with a minimally invasive mechanical aspiration thrombectomy system designed to remove peripheral blood clots. Walk Vascular’s peripheral thrombectomy systems will be incorporated into Abbott’s existing...
The CardioVascular Coalition (CVC), a group of physicians, care providers, advocates, and manufacturers working to improve awareness and prevention of peripheral arterial disease (PAD), has called on Congress and the Centers for Medicare & Medicaid Services (CMS) to address...
In October this year, a team of vascular surgeons, nurses, and healthcare scientists will take on a 185-mile cycle challenge through the Outer Hebrides Islands off the coast of Scotland, UK, in a bid to raise awareness and funding...
Carotid artery surgery and stenting have comparable long-term effects on fatal or disabling stroke in asymptomatic patients with severe carotid artery stenosis. That is the finding of late-breaking ACST-2 data presented in a Hot Line session at the European...
Medical management of type B aortic intramural haematomas is associated with low early mortality but a 19% risk of aortic-related intervention—primarily for proximal descending thoracic aneurysms, researchers from the Mayo Clinic in Rochester, USA, have found.
The investigators report that...
From a cost-effectiveness standpoint, primary stenting of the superficial femoral artery (SFA) for the treatment of intermittent claudication can, in many countries, be used as an adjunct to exercise training advice. This is the main conclusion of Henrik Djerf...
Poverty and Black race were associated with higher rates of lower leg amputation among people with peripheral arterial disease (PAD) who live in metropolitan areas, according to new research published today in a special issue of the Journal of the American Heart...
Shape Memory Medical has announced the initiation of AAA-SHAPE Netherlands, the company’s prospective, multicentre early feasibility study of the Impede-FX RapidFill device when used for abdominal aortic aneurysm (AAA) sac management during elective endovascular aneurysm repair (EVAR). The Dutch...
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the US Food and Drug Administration (FDA) has approved an expanded peripheral arterial disease (PAD) indication for the Xarelto (rivaroxaban) vascular dose (2.5mg twice daily plus aspirin 100mg once...
Following an online-only conference in 2020, this year's iteration of the European Society for Vascular Surgery (ESVS) Annual Meeting will take a hybrid format, with sessions held in Rotterdam, The Netherlands and online from 28–29 September. In this letter,...
W L Gore & Associates (Gore) has announced that five-year results from the US prospective, multicentre study (n=63) evaluating endovascular repair of iliac aneurysms using the Gore Excluder iliac branch endoprosthesis (IBE) were presented at the Society for Vascular...
Joseph V Lombardi (Cooper University Hospital, Camden, USA) reported long-term outcomes favouring the continued safety and effectiveness of a composite device (proximal covered stent graft plus distal bare stent) deployed for the endovascular repair of acute, type B aortic...
Silk Road Medical has announced positive results from an independent analysis of standard surgical risk patients undergoing carotid endarterectomy (CEA) and transcarotid artery revascularisation (TCAR) for atherosclerotic carotid disease. The analysis was presented at the Society for Vascular Surgery’s...
“A strategy of adding rivaroxaban 2.5mg twice daily to aspirin should be considered after lower extremity bypass regardless of conduit type,” concluded Nicholas Govsyeyev (University of Colorado, Aurora, USA) during the William J von Liebig Forum at the Society...
Fist Assist Devices has announced that data associated with the p-FACT cohort, a subset of the recently completed, non-significant risk Fist Assist clinical trial (FACT trial) that focused on vein dilation in stage four patients with chronic renal failure,...
A patient-level meta-analysis of randomised controlled trials (RCTs) has shown that drug-coated balloons (DCBs) were “consistently favoured” over percutaneous transluminal angioplasty (PTA) to prolong target lesion primary patency and access circuit primary patency in the treatment of dysfunctional haemodialysis...
A research letter published in Circulation: Cardiovascular Quality and Outcomes highlights a “very low” utilisation of supervised exercise therapy (SET) in symptomatic peripheral arterial disease (PAD) patients during the first 19 months after approval by the Centers for Medicare...
MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of patients with below-the-knee (BTK) disease. Selution SLR is the first DEB to be awarded Breakthrough...
MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of patients with below-the-knee (BTK) disease. According to a MedAlliance press release, Selution SLR is the...
Terumo Aortic has announced that the US Food and Drug Administration (FDA) has granted approval of its RelayPro thoracic stent-graft system for sale in the USA for the treatment of patients with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic...
The American Heart Association (AHA) has released a new scientific statement on lower extremity peripheral arterial disease (PAD), focusing on contemporary epidemiology, management gaps, and future directions.
The statement, authored by Michael H Criqui (University of California, San Diego,...
Updated Society for Vascular Surgery (SVS) clinical practice guidelines on extracranial cerebrovascular disease management and a new meta-analysis on paclitaxel in peripheral arterial disease caught readers' attention in July.
1. SVS releases updated clinical practice guidelines on extracranial cerebrovascular disease
The...
Fist Assist Devices has just announced completion of the FACT trial, which evaluated the use of an intermittent pneumatic compression device, model FA-1, to promote vein dilation in patients with kidney disease. The trial’s results suggest the device could...
Boston Scientific has commenced enrolment in the HI-PEITHO clinical trial, a collaborative research study with the Pulmonary Embolism Response Team (PERT) Consortium and the University Medical Center of the Johannes Gutenberg University of Mainz (Mainz, Germany) comparing use of...
With a firm eye on healing disparities in healthcare and within the vascular surgery specialty itself, the Society for Vascular Surgery (SVS) has published a 2021 Diversity Supplement as an addition to the August issue of the Journal of...
Cardinal Health and Hellman & Friedman (H&F) have revealed the completion of the previously announced sale of Cardinal Health's Cordis business to H&F. The sale price of approximately US$1 billion includes the buyer's assumption of certain liabilities and the...
Surmodics has announced that J. Michael Bacharach, a vascular interventionalist/cardiologist at North Central Heart, a division of Avera Heart Hospital in Sioux Falls, USA, successfully treated the first patient with the company’s Pounce thrombectomy system.
The procedure involved a patient...
Artio Medical announced today it has completed enrolment in its first-in-human study evaluating the Amplifi vein dilation system. In the study, five patients were treated by Adrian Ebner, head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asunción, Paraguay.
"I am very...
Percutaneous Deep Vein Arterialisation (pDVA) with the LimFlow System offers a cost-effective and high-value alternative to traditional therapies or amputation, according to a recent study published in the Journal of Critical Limb Ischemia.
Peter Schneider, professor of surgery at the University of...
Percutaneous Deep Vein Arterialisation (pDVA) with the LimFlow System offers a cost-effective and high-value alternative to traditional therapies or amputation, according to a recent study published in the Journal of Critical Limb Ischemia.
Peter Schneider, professor of surgery at the University...
“There appears to be heightened risk of major amputation after use of paclitaxel-coated balloons in the peripheral arteries,” findings from a systematic review and meta-analysis of randomised controlled trials (RCTs) published in the European Journal of Vascular and...
A large, single-centre retrospective study has revealed the risk of acute kidney injury (AKI) following pharmacomechanical thrombolysis (PMT) for lower extremity deep vein thrombosis (DVT) is as high as 22%.
PMT is an established treatment for selected patients with...
A retrospective analysis published in the Journal of Vascular Access (JVA) has shown that the oversized balloon angioplasty technique to assist arteriovenous (AV) fistula maturation is safe and effective—and allows cannulation of the fistula within hours or days of...
“There is no doubt in my mind that working together rather than competing against each other will not only be in our best interests but also provide better patient care,” Ali AbuRahma tells Vascular News, contemplating his goal of...
As regards in-hospital mortality for abdominal aortic aneurysm (AAA) repair, researchers have found that “not all risk scores are created equal”. Livia E V M de Guerre (Beth Israel Deaconess Medical Center, Boston, USA; University Medical Center, Utrecht, The...
A population-based study from 2013 to 2015 in Germany has found that nearly one fifth of patients with peripheral arterial disease (PAD) did not receive guideline-based vascular diagnostics three months before incidence amputation. Writing online in the European Journal...
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In this case report for Vascular News, experts outline the importance of recognising chronic venous obstruction as a crucial contributor to non-healing wounds in patients firstly...
This advertorial is sponsored by Bentley.
Based on his high-volume experience of branched repairs, Said Abisi, consultant vascular and endovascular surgeon at Guy’s and St Thomas’ NHS Foundation Trust (London, UK) offers his expert opinion on the use of the...
Endologix today announced the company’s ChEVAS (chimney endovascular aneurysm sealing) system has been granted a Breakthrough Device designation from the US Food and Drug Administration (FDA). The ChEVAS system is an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy...
Writing in an article published online in the Journal of Vascular Surgery (JVS), John F Charitable, Neal Cayne (both NYU Langone Health, New York, USA), and colleagues conclude that translumbar embolisation is a safe and effective treatment option for...
A systematic review and meta-analysis has demonstrated that patients undergoing carotid interventions after thrombolysis have a higher risk of periprocedural hazards, compared with those patients who did not have prior thrombolysis. Authors Stavros K Kakkos (University Hospital of Patras,...
Viz.ai has partnered with Avicenna.AI to enable intelligent care coordination and improve patient triage of patients suffering from pulmonary embolism (PE) and aortic disease.
Avicenna.AI’s US Food and Drug Administration (FDA)-approved algorithms for PE and type A and type B aortic...
Terumo Medical Corporation has announced today the introduction of its Azur vascular plug. The addition to Terumo's embolisation portfolio is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature.
"The Azur...
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“The E-nside device is a valuable addition to our current armamentarium for treating complex aortic disease,” Timothy Resch (Copenhagen Aortic Center , Copenhagen University Hospital,...
A German claims-based cohort study has revealed that—in 13,204 patients treated with a paclitaxel-coated device for peripheral arterial disease (PAD)—mortality differences were mostly attributable to a female subgroup treated above the knee, while no statistically-significant differences were observed in...
New data from Philips' TOBA II below-the-knee (BTK) clinical trial, physicians' call for the AMPREDICT decision support tool to be applied in clinical practice, and a study showing that arteriovenous fistulas (AVFs) contribute to higher survival of haemodialysis patients...
Surmodics recently announced that it has acquired privately-held Vetex Medical Limited. The Galway, Ireland-based medical device developer and manufacturer has focused exclusively on venous clot removal solutions. The transaction expands Surmodics’ thrombectomy portfolio with a second US Food and...
Brian DeRubertis (Los Angeles, USA) talks to Vascular News about the benefits and challenges of starting and running an office-based lab (OBL), which he outlined during his presentation at the recent Pacific Northwest Endovascular Conference (PNEC, 27–28 May, Seattle, USA).
There are...
In this issue:
Vascular community rallies to reduce “devastating” lower-extremity amputations (p. 1)
Fiber Optic RealShape used in the USA for first time (p. 14)
Renal Interventions: High-flow fistulas remain divisive, with uncertainty over reduction and outcomes (p. 24)
...
In this issue:
Vascular community rallies to reduce “devastating” lower-extremity amputations (p. 1)
Fiber Optic RealShape used in the USA for first time (p. 14)
Renal Interventions: High-flow fistulas remain divisive, with uncertainty over reduction and outcomes (p. 24)
...
In this third episode of a special five-part series on the history of DCBs, Jos van den Berg (Lugano, Switzerland) moderates a Vascular News roundtable discussion where he is joined by John Laird (St Helena, USA) and Peter Schneider (San Francisco,...
Vasorum Limited has announced the appointment of Bob Smouse as a non-executive director.
Vasorum specialises in devices used to close arterial punctures in vascular, cardiology, radiology, and neuroradiology procedures. In February of this year, the company raised €6 million in...
In a study of over 100,000 intact abdominal aortic aneurysm (AAA) repairs, an increase in the proportion of patients undergoing endovascular aneurysm repair (EVAR) over time has been demonstrated. This recent research, published in the European Journal of Vascular...
The Society for Vascular Surgery (SVS) has released updated clinical practice guidelines accompanied by an implementation document on the management of patients with extracranial carotid artery disease. The documents, both published in the Journal of Vascular Surgery, aim to...
Front Line Medical Technologies has announced that the US Food and Drug Administration (FDA) has cleared its COBRA-OS (Control of bleeding, resuscitation, arterial occlusion system). The COBRA-OS is the first 4 French resuscitative endovascular balloon occlusion of the aorta...
The Roadsaver carotid stent system (Terumo France/Europe and MicroVention Europe) has been reimbursed in France. This follows the positive assessment from the French National Authority for Health (HAS), which highlighted a therapeutic benefit of the device.
“This decision bears...
The Society for Vascular Surgery (SVS) has released new clinical practice guidelines to ensure that patients with popliteal artery aneurysms receive appropriate treatment and care. Aneurysms of the popliteal artery are the most common aneurysms outside of the brain...
The role of artificial intelligence (AI) has the potential to be “transformative” in medicine, including in vascular surgery. This is according to Alan Karthikesalingam, the UK Research Lead at Google Health (London, UK) and a vascular surgery lecturer, who...
Further stratification according to preprocedural symptoms in patients undergoing transfemoral carotid artery stenting (TFCAS) improves the preoperative risk assessment, a review of the Society for Vascular Surgery (SVS)’s Vascular Quality Initiative (VQI) data suggests.
According to principal author Marc L...
Concept Medical has provided an update on the progress of the IMPRESSION (Sirolimus-coated balloon angioplasty versus plain balloon angioplasty in the treatment of dialysis access dysfunction) trial—a prospective, multicentre, two-arm parallel group, randomised clinical study designed to assess the...
The Society for Vascular Surgery (SVS) today announced its officers for 2021–2022. Several officers shifted roles and Joseph L Mills (Baylor College of Medicine, Houston, USA) was elected vice president at the SVS annual business meeting, held virtually on...
Anna Prent (London, UK) chats to Vascular News at London Aortic Symposium (11–12 October 2018, London, UK), about the need to treat type I endoleaks due to the “high risk of secondary sac perfusion and rupture”.
Patients should receive “tailor-made...
Speaking on current trends in amputation rates with critical limb-threatening ischaemia (CLTI) patients, Misty Humphries (Sacramento, USA) tells Vascular News that while Medicare data shows that amputation rates are decreasing across the USA overall, there are “certain geographical areas” that have high rates, with many...
Cagent Vascular recently announced the investment of US$9 million by Sectoral Asset Management. Along with the investment, Marc-Andre Marcotte has joined the board of directors. The proceeds will be used to accelerate the commercialisation and scaling of manufacturing for...
According to a new, population-based analysis, abdominal aortic aneurysm (AAA) mortality has continued to decline and “at a faster rate than ever” in the second decade of the 21st century. Authors C Y Maximilian Png (Massachusetts General Hospital, Boston,...
Femoropopliteal bypass is associated with decreased reinterventions at one year compared to endovascular therapy in patients with advanced premature peripheral arterial disease (PAD). This is the primary conclusion of Tanner I Kim (Yale School of Medicine, New Haven, USA)...
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“Improving vessel compliance with focused force longitudinal plaque fracture seems to be a promising strategy instead of standard percutaneous transluminal angioplasty ,” states interventional angiologist Michael...
Writing in an online Vascular Medicine article, researchers from the Intersocietal Accreditation Commission (IAC) Vascular Testing division report findings from a multicentre study of duplex ultrasound for diagnosis of internal carotid artery (ICA) stenosis.
The study was developed in response to...
A new study, published online in The Journal of Vascular Access (JVA), suggests that arteriovenous fistulas (AVFs) contribute to higher survival of haemodialysis patients with COVID-19. Authors Ahmet Murt (Istanbul University-Cerrahpasa, Istanbul, Turkey) and colleagues urge that end-stage renal...
Researchers have found that the AMPREDICT decision support tool (DST) demonstrates “strong usability characteristics and clinical relevance” in amputation level decision-making for patients with chronic limb-threatening ischaemia (CLTI). Daniel C Norvell (VA Puget Sound Health Care System, Seattle, USA)...
AngioDynamics recently announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for the AlphaVac mechanical thrombectomy system.
According to a company press release, AlphaVac is an off-circuit, multipurpose mechanical aspiration thrombectomy device for the...
TripleMed BV recently announced an enrolment update regarding the pivotal clinical study of the company’s AneuFix product for the treatment of type II endoleaks.
According to a TripleMed press release, 13 patients have been successfully treated with AneuFix without any...
Prytime Medical has announced the closing of a US$6 million inside financing round to support commercialisation of its resuscitative endovascular balloon occlusion of the aorta (REBOA) haemorrhage control products.
"REBOA is different now," said Andrew Holman, chief commercialisation officer at Prytime....
Royal Philips recently announced positive two-year results from the TOBA (Tack optimised balloon angioplasty) II below-the-knee (BTK) clinical trial.
The data show the Philips Tack endovascular system (4F), a first-of-its kind dissection repair device, provides a sustained treatment effect...
Expanding eligibility for endovascular aneurysm repair (EVAR), new tools for chronic limb-threatening ischaemia (CLTI), and promising data for arteriovenous (AV) fistula remote monitoring all feature in our top 10 most read stories of May 2021.
1. Concern for outgrowing EVAR...
Cardiovascular Systems has announced that the full line of OrbusNeich Jade percutaneous transluminal angioplasty (PTA) over-the-wire (OTW) balloon catheters is now available in the USA. Cardiovascular Systems is the exclusive US distributor of OrbusNeich balloon products.
Jade is an OTW...
Rupert Bauersachs (Darmstadt, Germany) talks to Cardiovascular News about the VOYAGER-PAD trial, the results of which he presented at the American College of Cardiology’s 70th Annual Scientific Session (ACC.21, 15–17 May, virtual) and which highlighted a reduced risk of...
SoundBite Medical Solutions recently announced the use of its novel Active Wire 0.014” platform at a first site in the USA in the successful treatment of patients suffering from chronic limb-threatening ischaemia (CLTI) with heavily calcified lower limb chronic...
Simulators have long been used for training surgeons and surgical teams, but traditional simulator platforms typically have a built-in limitation: they often simulate one or a limited number of conditions that require performance of isolated tasks, such as placing...
Many individuals with kidney failure have been unable to self-isolate during the COVID-19 pandemic because they require dialysis treatments in clinics several times a week. New research that will appear in an upcoming issue of the Clinical Journal of...
Medical imaging artificial intelligence (AI) specialist Avicenna.AI recently announced that it has received certification in the USA and European Union (EU) for CINA CHEST, its new AI solution that leverages deep learning algorithms for emergency triage of deadly vascular...
Women who experience acute aortic dissection are older, have more advanced disease than men when they seek medical care, and are also more likely to die, according to research published online in The Annals of Thoracic Surgery.
“Data over the...
Andrew Holden (Auckland, New Zealand) presents the latest results from the IN.PACT™ AV Access trial (Medtronic), which indicate “outstanding” target-lesion primary patency rates of 52.2% through 24 months in dialysis patients with dysfunctional arteriovenous fistulas (AVFs), offering a “highly-significant advantage” over standard...
Boston Scientific and BD have both initiated recalls of venous stents. According to a US Food and Drug Administration (FDA) medical device recall notice posted 21 May, Boston Scientific has recalled its Vici venous stent system (Vici SDS) and...
Koya Medical announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for the treatment of lymphoedema and venous diseases that impact lymphatic flow in the lower extremities....
Koya Medical announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for the treatment of lymphoedema and venous diseases that impact lymphatic flow in the lower extremities....
Fifteen years’ worth of data from a major US trauma centre suggest that the involvement of vascular surgeons in trauma management has increased over time. Based on this finding, authors Jake F Hemingway (University of Washington, Seattle, USA) and...
A systematic review and meta-analysis has found that transcarotid artery revascularisation (TCAR) is associated with “promising early and late outcomes” in patients with internal carotid artery stenosis, although symptomatic patients still carry a higher risk of early cerebrovascular events....
Additional randomised controlled data regarding the effectiveness of drug-coated balloons (DCBs) in maintaining arteriovenous (AV) access offers new evidence, but it is freighted with uncertainty. However, specific modelling suggests fewer reinterventions could reinforce economic benefits when the IN.PACT AV...
Koya Medical announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for the treatment of lymphoedema and venous diseases that impact lymphatic flow in the lower extremities....
This week Medtronic announced that it has sent physicians updated patient management recommendations related to its voluntary recall of the Valiant Navion thoracic stent graft on 17 February.
The original recall notice included the recommendation for physicians to follow best...
The European Union (EU) Medical Devices Regulation (MDR) takes effect from today (26 May 2021).
The Regulation revises quality and safety standards and the range of regulated devices and was first initiated in May 2017, with an initial three-year transition...
The European Union (EU) Medical Devices Regulation (MDR) takes effect from today (26 May 2021).
The Regulation revises quality and safety standards and the range of regulated devices, and was first initiated in May 2017, with an initial three-year transition...
Transit Scientific today announced that its XO Score scoring sheath platform has been named a winner in the 2021 Medical Design Excellence Awards (MDEA). The MDEA is a premier design competition in the medtech industry, recognising significant achievements in...
Concept Medical has released a series of status updates on their head-to-head SIRONA (Sirolimus versus paclitaxel drug-eluting balloon angioplasty in femoropopliteal diseases) randomised controlled trial (RCT).
SIRONA is an investigator-initiated and -driven, prospective, multicentre, corelab-adjudicated trial involving peripheral arterial disease...
LeMaitre today announced that it received CE marks under the European Medical Devices Directive (93/42/EC as amended by 2007/47/EC) for the following five products. Marks for the five products had previously lapsed due to a change in notified bodies.
Product
Notified Body
Expiration...
Prytime Medical Devices recently announced it has received both UK and CE mark approval for its ER-REBOA Plus catheter. Designed for improved ease of use, this catheter replaces the ER-REBOA catheter and, according to a press release, "represents an...
LimFlow SA recently announced the publication of 12-month data from the full patient cohort in its PROMISE I study of the LimFlow percutaneous deep vein arterialisation (pDVA) system in the Journal of Vascular Surgery.
Results showed sustained positive outcomes...
LimFlow SA recently announced the publication of 12-month data from the full patient cohort in its PROMISE I study of the LimFlow percutaneous deep vein arterialisation (pDVA) system in the Journal of Vascular Surgery.
Results showed sustained positive outcomes...
Tilo Kölbel (Hamburg, Germany; moderator) is joined by Geert Willem Schurink (Maastricht, Netherlands) and Joost van Herwaarden (Utrecht, Netherlands) in this Vascular News roundtable, titled Bringing 3D device guidance into the hybrid lab with Fiber Optic RealShape (FORS) technology.
FORS...
Researchers have found no statistically significant difference in mortality between patients treated with drug-coated devices and non-drug-coated devices in the SAFE-PAD study. Eric Secemsky (Beth Israel Deaconess Medical Center , Boston, USA) reported this conclusion at the American College...
Rivaroxaban (Xarelto, Bayer/Janssen), in addition to low-dose aspirin, should be considered as an adjunctive therapy after lower extremity revascularisation to reduce first and subsequent adverse outcomes, analysis from VOYAGER PAD, presented during a late-breaking trial session at the American...
Medtronic today announced new clinical data from the Global SYMPLICITY registry (GSR) indicating that renal denervation with the Medtronic Symplicity renal denervation system was associated with clinically significant and sustained blood pressure reductions in a real-world hypertensive patient population...
The Auryon atherectomy system (AngioDynamics) “represents an exciting new technology”, John Rundback (Advanced Interventional and Vascular Services, LLP, Teaneck, USA) opined at the International Symposium on Endovascular Therapies (ISET; 9–11 May, Miami, USA, and online), speaking on behalf of...
In a recent study, Victor Demaerel (University Hospitals Leuven, Leuven, Belgium) and colleagues found that tunnelled haemodialysis catheter (THC) survival in 352 patients was more than 70% after five years. This finding, they conclude, “supports use for permanent...
“The majority of patients eligible for EVAR when entering a surveillance programme for small AAA remain eligible after two years,” write Annalise M Panthofer (University of Wisconsin, Madison, USA) and colleagues in the Journal of Vascular Surgery...
“I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider (University of California San Francisco, San Francisco, USA) told delegates attending the International Symposium on Endovascular Therapy (ISET; 9–11 May, Miami, USA),...
“I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider (University of California San Francisco, San Francisco, USA) told delegates attending the International Symposium on Endovascular Therapy (ISET; 9–11 May, Miami, USA),...
A recent systematic review and narrative synthesis has found several tools that demonstrate “acceptable-to-outstanding discrimination” for predicting key outcomes following major lower limb amputation. However, authors Ryan A Preece (Royal Gwent Hospital, Cardiff, UK) and colleagues note that “additional...
Transit Scientific recently announced it has received CE mark clearance in the European Union for the XO Score scoring sheath platform to facilitate dilation of stenotic material in the peripheral vasculature including popliteal, infrapopliteal, and native or synthetic arteriovenous...
Endologix today announced the first implant of its Alto abdominal stent graft in Canada following recent approval from Health Canada. Alto was also recently approved for commercial sale in Argentina.
According to a company press release, the Alto abdominal stent...
NOTE: This video is ONLY available to watch in selected countries and geographies
Robert Rhee (New York, USA) moderates a Charing Cross 2021 webinar–A deep dive in the GORE® ACTIVE CONTROL System–where he is joined by Robin Heijmen (Nieuwegein,...
MolecuLight has partnered with Tissue Analytics, a Net Health company that provides software for the woundcare industry. The purpose of the partnership is to integrate the MolecuLight platform with Net Health’s Tissue Analytics application programming interface (API) programme.
For clinical sites...
Highlights from the Charing Cross (CX) 2021 Digital Edition (19–22 April, online)—including the potential of Philips’ Fiber Optic RealShape (FORS) technology to reduce radiation and improve ease of deployment with shorter operation times—caught readers’ attention in April.
1. Endologix announces...
A new wearable device designed to remotely monitor arteriovenous (AV) fistulae function in dialysis access patients uncovered promising data leading one set of researchers to conclude the technology offers hope for improved care and lower costs among a challenging...
Members of the peripheral arterial disease (PAD) Task Force—including the Association of Black Cardiologists (ABC), CardioVascular Coalition, CLI Global Society, Preventative Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology—recently commended introduction of the...
iVascular has received CE mark approval for its balloon-expandable covered stent, iCover, a press release from the company states.
Balloon-expandable covered stents are commonly used for treating arteriosclerotic lesions in renal and iliac arteries, and for the treatment of aneurysms...
Micro Medical Solutions (MMS) recently announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its MicroStent vascular stent. This novel technology is designed to achieve and maintain vessel patency, enhance wound treatment, and...
Micro Medical Solutions (MMS) recently announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its MicroStent vascular stent. This novel technology is designed to achieve and maintain vessel patency, enhance wound treatment, and...
“Not all Drug-Coated Balloons (DCBs) are created equal”, Juan Granada (New York, USA), tells Vascular News in this second episode of a five-part series on the history of DCBs.
Granada discusses why there are differences in these devices, noting that some have a longer term retention of drug,...
Independent Vascular Services (IVS) recently announced the launch of its new Corelab Remote Quality Assurance (QA) service for the UK National Abdominal Aortic Aneurysm Screening Programme (NAAASP). The service targets programmes across the country, offering to support their existing...
Vascular Therapies recently announced results from its phase 3 clinical trial in which Sirogen showed encouraging arteriovenous fistula (AVF) outcomes in elderly end-stage renal disease (ESRD) patients. Sirogen is the company's proprietary sirolimus formulation for intraoperative local drug delivery...
BD announced today that enrolment has begun and the first patients have been treated in the postmarket surveillance study, CONNECT-AV.
CONNECT-AV is a prospective, single-arm, open-label study that will follow patients treated with the WavelinQ endovascular arteriovenous fistula (endoAVF) system...
MolecuLight has appointed 11 specialised global distributors for its i:X fluoresence wound imaging device. The i:X device enables point-of-care fluorescence imaging for the detection of wounds containing elevated bacterial loads.
MolecuLight’s Distributors are Tradis Gat ltd. (Israel), Al Zahrawi...
A multicentre retrospective study of the PROOVIT (Prospective observational vascular injury treatment) registry suggests the use of temporary intravascular shunts (TIVSs) results in lower rates of amputation during the early phase of care and should be part of a...
Addressing representatives from the US Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA) directly, Thomas Zeller (Bad Krozingen, Germany) argued at the Charing Cross (CX) Digital Edition 2021 (19–22 April, online) that “it...
In a Gore-sponsored satellite symposium at the 2021 Charing Cross (CX) Digital Edition (19–22 April, online), Richard Neville (Falls Church, USA) and Walter Dorigo (Florence, Italy) talked through their data and experiences of below-the-knee bypass, citing the benefits of...
There is a global crisis, also playing out in developed Western countries, in which too many people are having unnecessary amputations, so losing their limbs, or at risk of pulmonary embolism and death due to missed superficial or deep...
The results of a recent investigation have revealed no association between infrainguinal bypass tunnelling technique and primary outcomes in patients with limb ischaemia. “Compared to subfascial tunnelling,” write Nallely Saldana-Ruiz (University of Southern California, Los Angeles, USA) and colleagues...
Results of the French ACTA (Aortic concomitant thoracic and abdominal aneurysm) study “confirm that thoracic aortic aneurysms (TAAs) coexisting with abdominal aortic aneurysms (AAAs) are not rare”, write Marine Gaudry (Timone Hospital, Marseille, France) and colleagues in the European...
Soundbite Medical Solutions has announced US Food and Drug Administration (FDA) 510(k) approval for the SoundBite crossing system—Peripheral (SCS-P) with the 0.014” active wire (14P).
The SoundBite crossing system—Peripheral (14P) is a recanalisation tool, designed to help physician’s placement of...
The results of a recent investigation have revealed no association between infrainguinal bypass tunnelling technique and primary outcomes in patients with limb ischaemia. “Compared to subfascial tunnelling,” write Nallely Saldana-Ruiz (University of Southern California, Los Angeles, USA) and colleagues...
Medtronic recently announced the safety and effectiveness results through 24 months for the IN.PACT AV Access clinical study. The data, which were presented virtually as a Podium 1st at the Charing Cross (CX) 2021 Digital Edition (19–22 April, online)...
NOTE: This video is ONLY available to watch in selected countries and geographies
Koen Deloose (Dendermonde, Belgium) moderates a three-part Vascular News series about the Luminor drug-coated balloon (DCB; iVascular) in different indications. He is joined by Tjun Tang (Singapore) and...
NOTE: This video is ONLY available to watch in selected countries and geographies
Koen Deloose (Dendermonde, Belgium) moderates a three-part Vascular News series about the Luminor drug-coated balloon (DCB; iVascular) in different indications. He is joined by Tjun Tang (Singapore) and...
NOTE: This video is ONLY available to watch in selected countries and geographies
Koen Deloose (Dendermonde, Belgium) moderates a three-part Vascular News series about the Luminor drug-coated balloon (DCB; iVascular) in different indications. He is joined by Tjun Tang (Singapore) and...
One-year findings from B Braun’s CONSEQUENT ALL COMERS observational study were recently published by principal investigator Ralf Langhoff (Sankt Gertrauden Hospital, Berlin, Germany) et al online in Angiology. The data were first presented earlier this year at LINC 2021 (The Leipzig...
A series of debates tested expert response to current acute stroke controversies during the final day of the Charing Cross (CX) 2021 Digital Edition (19–22 April, online). A major talking point at the Acute Stroke Controversies session was the...
Vascular surgeons have an integral role to play in major haemorrhage protocol (MHP) trauma calls, polling taken during the Vascular Trauma Controversies session at Charing Cross (CX) 2021 Digital Edition (19–22 April, online) reveals. Attendees of the final session...
There is a global crisis, also playing out in developed Western countries, in which too many people are having unnecessary amputations, so losing their limbs, or at risk of pulmonary embolism and death due to missed superficial or deep...
In a Gore-sponsored satellite symposium at the 2021 Charing Cross (CX) Digital Edition (19–22 April, online), Richard Neville (Falls Church, USA) and Walter Dorigo (Florence, Italy) talked through their data and experiences of below-the-knee bypass, citing the benefits of...
The message that outcomes depend on the underlying pathology was front and centre during the Thoracic Aortic Controversies discussion at the Charing Cross (CX) 2021 Digital Edition (19–22 April, online). The day also featured a decisive vote that patients...
Consensus is split over the need for flow reduction in high-flow fistulas to avoid cardiac complications in dialysis patients, polling taken during the Charing Cross (CX) 2021 Digital Edition (19–22 April, online) has revealed. Attendees to the Vascular Access...
Addressing representatives from the US Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA) directly, Thomas Zeller (Bad Krozingen, Germany) argued at the Charing Cross (CX) Digital Edition 2021 (19–22 April, online) that “it...
In a Gore-sponsored Satellite Symposium at the Charing Cross Symposium (CX; 19–22 April, online), Michele Piazza (Padua, Italy) moderated a discussion on occlusive Iliac artery pathology, covering guidelines, treatment algorithms, and current knowledge gaps.
Manuel Alonso Perez (Oviedo, Spain) first...
Opening the Charing Cross (CX) 2021 Digital Edition (19–22 April, online), experts deliberated crucial controversies in the abdominal aortic space. Discussion emphasised the potential of Philips’ Fiber Optic RealShape (FORS) technology to reduce radiation and ease technical success, with...
“In native or stentgraft aortic infections, when a biological solution is not feasible, the antimicrobial Synergy graft (Getinge) offers an alternative solution with a low rate of reinfections,” Xavier Bérard (Bordeaux University Hospital, Bordeaux, France) told virtual attendees of...
A mid-term assessment of bridging stentgraft integrity and flare geometry following fenestrated endovascular aortic repair (FEVAR) finds that, although there is a substantial reintervention rate post-procedurally, most are not related to the use of balloon-expandable covered stents (BECS). This...
Endovascular aortic repair (EVAR) is safe, durable, and effective, the five-year interim results of the Global Registry for Endovascular Aortic Treatment (the GREAT registry) show. In this analysis of more than 3,000 abdominal aortic aneurysm (AAA) patients treated with...
Gianmarco de Donato (Siena, Italy) discusses the findings from the INDIAN registry, which were presented during CX 2021 (Charing Cross Symposium; 19–22 April, online) and were recently published in the European Journal of Vascular and Endovascular Surgery. The registry sought...
Patrick Kelly (Sioux Falls, USA) and Peter Schneider (San Francisco, USA) discuss a novel technology from BlueDop Medical that uses a patented process to determine ankle blood pressure from a simple Doppler signal “without a blood pressure cuff at...
Bactiguard expands its business in the wound care market by partnering with the Spanish company Farmaban S A. The partnership enables Bactiguard to reach the Spanish market with its full range of products.
"We have found a very good match...
The Altura™ Endograft System (Lombard Medical) is an “outstanding leap forward”, Jörg Teßarek (Lingen, Germany) tells Vascular News, while describing his experience with the both the standard and fenestrated Altura™ devices.
Teßarek draws particular attention to the main features of...
A recent study on iliac vein stenting showed better short- and mid-term patency rates when intravascular ultrasound (IVUS) was utilised prior to stent deployment in addition to multiplanar venography compared to venography alone. The data were presented at VENOUS2021 (17–20...
The results of a two-year study support the continued safety and effectiveness of the Zilver Vena Venous Stent (Cook Medical) in treating symptomatic iliofemoral venous outflow obstruction, according to findings presented at the 2021 meeting of the Society of...
A pooled meta-analysis found that patients with symptomatic carotid stenosis enrolled in recent randomised controlled trials (RCTs) had a lower risk of stroke after randomisation than historical controls. According to authors Urs Fisch (University of Basel, Basel, Switzerland) and...
A multicentre retrospective study of the PROOVIT (Prospective observational vascular injury treatment) registry suggests the use of temporary intravascular shunts (TIVSs) results in lower rates of amputation during the early phase of care and should be part of a...
Endologix recently announced it has completed the acquisition of PQ Bypass, a medical technology company pioneering a first-of-its-kind technology that addresses an unmet need for new treatments for severe peripheral arterial disease (PAD).
PQ Bypass’ proprietary Detour platform for percutaneous...
NOTE: This video is ONLY available to watch in selected countries and geographies
Sabine Steiner (Leipzig, Germany) sits down with Michael Jaff, the CMO & VP of Boston Scientific, USA, to discuss the two-year results from the COMPARE trial,...
Vivasure Medical recently announced that Andrew Glass has assumed the role of chief executive officer. Founder and former CEO Ger Brett will transition to serving as chief operating officer.
Glass has extensive leadership, commercial operations, and product development experience in...
“We are going to be seeing more and more complex procedures in the aortic arch and thoracoabdominal aorta”, Gustavo Oderich (University of Texas Health Science Center, Houston, USA) tells Vascular News ahead of this year’s Charing Cross Symposium (CX; 19–22 April, online)....
Newly-published data on the benefits of a dedicated vascular limb salvage clinic, key product launches in the vascular access space, and evidence to suggest dual screening for lung cancer and abdominal aortic aneurysms (AAA) could save lives all feature...
While there is large variability based on the site of insertion, patient characteristics and previous accesses, fluoroscopically-guided insertion of tunnelled central venous catheters (td-CVC) for dialysis can be considered a “low exposure” procedure, according to a report.
The report, which...
Royal Philips today announced US Food and Drug Administration (FDA) 510(k) clearance for its Philips SmartCT application software. SmartCT is a key component of Philips' image guided therapy system—Azurion—providing interventionalists with computed tomography (CT)-like three-dimensional (3D) images (cone beam...
Surmodics recently announced the successful first uses in patients for two devices within its Sublime radial access platform: the Sublime radial access guide sheath and Sublime radial access .014 RX percutaneous transluminal angioplasty (PTA) dilatation catheter.
Constantino Pena, Andrew Niekamp,...
William Jeffcoate (Nottingham, UK) discusses his upcoming presentation at the Hurting Leg session at CX 2021, titled The impact of socio-economic and clinical variables on the incidence of major amputation in people with diabetic foot ulcers. The session, which...
“The available data suggest that exercise training improves de-oxygenation and re-oxygenation patterns, as measured with near infrared spectroscopy (NIRS), in patients with lower extremity arterial disease (LEAD),” conclude Nils Cornelis, Panagiotis Chatzinikolaou (both KU Leuven, Leuven, Belgium) and colleagues...
“The available data suggest that exercise training improves de-oxygenation and re-oxygenation patterns, as measured with near infrared spectroscopy (NIRS), in patients with lower extremity arterial disease (LEAD),” conclude Nils Cornelis, Panagiotis Chatzinikolaou (both KU Leuven, Leuven, Belgium) and colleagues...
Nicholas Inston (Queen Elizabeth Hospital Birmingham, Birmingham, UK) speaks to Vascular News ahead of this year’s Charing Cross Symposium (CX), which is being held online 19–22 April. In 2021, the conference will focus on controversies within the vascular and endovascular space.
Could you outline...
In a large, multicentre study, women undergoing fenestrated or branched endovascular aneurysm repair (F/BEVAR) for thoracoabdominal aortic aneurysms (TAAA) demonstrated metrics of increased complexity and had a lower level of technical success. However, women had similar 30-day mortality and...
Researchers from The University of Western Australia (UWA; Perth, Australia) have partnered with industry to conduct a world-first study to investigate a new product—a topical cream containing the drug PXS-6302 (Pharmaxis)—that has the potential to prevent or reduce scars...
Zinc ferrite (ZnFe2O4) nanoparticles have the potential to be used as a future antimicrobial and wound-healing drug, a recent study in the Journal of Nanobiotechnology reports. Lead author Reihaneh Haghniaz (University of California Los Angeles , Los Angeles, USA)...
A new review concludes that the implementation of clinical guidelines for the management of patients with deep vein thrombosis (DVT) varies among countries, from strict adherence to no adherence at all. “In this content,” suggest authors Carla Rognoni (SDA...
Today, W L Gore & Associates (Gore) announced the first use of the US Food and Drug Administration (FDA)-approved Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprothesis with Active Control system in cases outside of clinical trials. Cases were...
Researchers suggest that in patients with chronic limb-threatening ischaemia (CLTI), two-dimensional (2D) perfusion angiography is a “reliable tool” when used according to standardised methods. Jetty Ipema (St Antonius Hospital, Nieuwegein, The Netherlands) and colleagues write in the European Journal...
Shape Memory Medical recently announced that it has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to market its Impede-FX embolisation plug in Japan. Cosmotec championed the approval process in Japan and is Shape Memory Medical’s...
LimFlow announced today that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved its Clinical Trial Notification (CTN) for the Japanese cohort of the ongoing PROMISE II pivotal trial of the LimFlow percutaneous deep vein arterialisation (pDVA) system.
PROMISE...
LimFlow SA announced today that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved its Clinical Trial Notification for the Japanese cohort of the ongoing PROMISE II pivotal trial of the LimFlow percutaneous deep vein arterialisation (pDVA) system.
PROMISE...
A single-centre, retrospective study reveals that approximately 11% of patients diagnosed with lung cancer concurrently have an abdominal aortic aneurysm (AAA). Researchers theorise dual screening could save lives.
There is significant overlap in the populations screened for lung cancer and...
Cardiovascular Systems recently announced that it has acquired a line of peripheral support catheters from WavePoint Medical.
Peripheral support catheters are used during peripheral vascular intervention (PVI) procedures for guidewire support to enable lesion crossing, as well as for guidewire...
The MolecuLight i:X platform (from MolecuLight), which uses fluorescence imaging for the point-of-care detection of wounds containing elevated bacterial loads, is now available to 650 long-term healthcare facilities in the USA through the company’s new commercial arrangement with Synergy...
Hyperbaric oxygen therapy (HBOT) can reduce thermal wound complications, length of stay in hospitals due to thermal burns, intercellular adhesion molecule 1 (ICAM-1) mRNA gene expression, and ICAM-1 serum level, a case-control study published in Annals of Medicine and...
On 19 March, the first patient was included in the BeGraft fenestrated endovascular aneurysm repair (FEVAR) study investigating the Bentley BeGraft peripheral balloon expandable covered stent in complex aortic aneurysms.
The patient was referred for FEVAR with a 6cm juxtarenal...
Vetex Medical has announced US Food and Drug Administration (FDA) 510(k) clearance for the ReVene thrombectomy catheter.
ReVene uses dual-action technology designed to de-clot peripheral vessels, such as in deep vein thrombosis (DVT), through wall-to-wall contact in a single...
A new study has found that patients who require recanalisation of a completely occluded venous outflow tract before stenting have a high rate of early reocclusion. Writing in the Journal of Vascular Surgery: Venous and Lymphatic Disorders, William A...
Penumbra today announced US commercial availability of the Indigo system Lightning 7. Lightning 7 expands Penumbra’s offering of the Indigo aspiration system with Intelligent Aspiration for mechanical thrombectomy and is designed for single session arterial thrombus removal.
Offering a new...
“The technique of inserting tunnelled dialysis catheters (TDCs) in the right internal jugular vein without fluoroscopy is a safe and effective method in selected patients”, write Zi Yun Chang (National University Health System, Singapore) and colleagues in The Journal...
Cardiovascular Systems has announced that the first patients in the USA have been treated with the Wirion embolic protection system. Wirion is a distal embolic protection filter used to capture thrombus and debris that can be associated with all...
In an assessment of open aortic surgery by the International Consortium of Vascular Registries (ICVR), 13–16 procedures per year predicted the most significant reduction in mortality after intact open abdominal aortic aneurysm (AAA) repair. However, researchers found that only...
Transit Scientific recently received CE mark approval in the European Union for its non-tapered metal alloy XO Cross microcatheter platform, a press release reports.
Microcatheters are commonly used to provide guidewire support, facilitate guidewire exchanges, access distal anatomy, cross...
MedAlliance recently announced that it has raised over US$50 million in equity funding. The new investor is Trustar Capital (formerly known as CITIC Capital Partners).
Proceeds from the financing will be used to fund commercialisation of the Selution SLR sirolimus-eluting...
Medtronic recently announced the launch of its Chameleon percutaneous transluminal angioplasty (PTA) balloon catheter in the following countries: Germany, Italy, Portugal, South Africa, Spain, and Turkey. The device is indicated for use in native or synthetic arteriovenous dialysis fistulae,...
This advertorial, sponsored by CryoLife, is only available in selected countries and geographies.
Within the scope of the PLIANT II study, the 100th patient was treated with the E-liac Stent Graft System on 4 December 2020. The implantation was...
In this issue:
What to expect from CX 2021 (pages 1–15)
A year in profiles (page 22)
Study suggests patients with depression less likely to go home after critical limb revascularisation (page 30)
New data find strong association between asymptomatic carotid...
In this issue:
What to expect from CX 2021 (pages 1–15)
A year in profiles (page 22)
Study suggests patients with depression less likely to go home after critical limb revascularisation (page 30)
New data find strong association between...
This advertorial is sponsored by Bentley.
There are numerous covered stents on the market that are used as bridging stents in fenestrated endovascular aneurysm repair (FEVAR). However, these stents have always been used off-label for such procedures. Now, a physician-initiated...
This advertorial, sponsored by BD, is only available in selected countries and geographies.
Martin Schroeder—a vascular surgery specialist at the Ruhr University Bochum Marienhospital Herne in Herne, Germany—has extensive clinical experience with the LifeStream™ balloon-expandable vascular covered stent (Bard)....
Cardinal Health recently announced that it has signed a definitive agreement to sell its Cordis business to Hellman & Friedman (H&F) for approximately US$1 billion, which includes buyer's assumption of certain liabilities and seller's retention of certain working capital...
Shape Memory Medical has announced CE mark approval for the Impede-FX RapidFill device, an expansion of the Impede family of biodegradable peripheral vascular embolisation plugs.
Ted Ruppel, president and CEO of Shape Memory Medical said, "We are excited to introduce...
Merit Medical Systems recently announced the enrolment of the first patients in its Wrapsody arteriovenous (AV) access efficacy pivotal (WAVE) study of the Wrapsody endovascular stent graft, an investigational device being studied for the treatment of stenosis or occlusion within...
Andrew Holden (Auckland City Hospital; University of Auckland, Auckland, New Zealand) speaks to Vascular News ahead of this year’s Charing Cross Symposium (CX), which is being held online 19–22 April. In 2021, the conference will focus on controversies within...
Renal artery involvement (RAI) in endovascular aneurysm repair (EVAR) is “highly predictive of the need for postoperative and permanent dialysis,” Anastasia Plotkin (University of Southern California, Los Angeles, USA) and colleagues write in the Journal of Vascular Surgery (JVS)....
Point-of-care duplex ultrasound (PAD-scan) is a cost-effective test for the detection of peripheral arterial disease (PAD) in patients with diabetes. This is the conclusion of a study recently published online in Annals of Surgery.
Authors Pasha Normahani (Imperial College NHS...
Access Vascular recently announced it has closed on a Series B round of financing. TVM Capital Life Science led the round with a US$15 million commitment, with existing investors also participating.
Access Vascular has developed a proprietary biomaterial platform that is both...
Humacyte has announced that the clinical results of five-year outcomes in patients receiving the human acellular vessels (HAV) for arteriovenous (AV) access in haemodialysis have been accepted for oral presentation at the Charing Cross (CX) Symposium (19–22 April, online)....
To mark the 20-year anniversary of drug-coated balloons, Bruno Scheller (Homburg/Saar, Germany) and Gunnar Tepe (Rosenheim, Germany), talk to Vascular News about their contributions to the birth and evolution of these devices.
Scheller discusses his work in the 1990s with...
Cutimed Sorbact (from Essity) has received a 2021 Innovative Technology contract from Vizient, the largest member-driven, healthcare performance improvement company in the USA.
The contract was awarded based on the recommendations of health care experts serving on a Vizient member-led...
Fluorescence imaging using the MolecuLight i:X can rapidly detect Pseudomonas aeruginosa (PA) in common wounds, a new study published in Diagnostics confirms. PA is a common bacterial pathogen in wounds known for its propensity to form biofilms and evade...
In a comparison of two clinical scales that assess quality of life (QoL) in post-thrombotic syndrome, Angela Lee (McGill University, Montreal, Canada) and colleagues conclude that, when a single scale is used for this purpose, the Villalta scale will...
ControlRad has announced US Food and Drug Administration (FDA) 510(k) clearance to market ControlRad Select, a technology that utilises proprietary semi-transparent filters, a user-interface tablet, and image processing algorithms to reduce radiation exposure during fluoroscopically guided procedures.
The technology is...
Medtronic has announced the launch of IN.PACT AV drug-coated balloon (DCB) in Japan. IN.PACT AV DCB is indicated for the treatment of obstructive lesions up to 100mm in length in the native arteriovenous (AV) dialysis fistulae in patients with...
One-year outcomes of patients with chronic-limb threatening ischaemia (CLTI) treated in an outpatient-based vascular limb salvage clinic show an improved rate of major amputation. Authors Andrew Nickinson (University of Leicester, Leicester, UK) and colleagues write in an online European...
The first detailed surgical results from the UK National Health Service (NHS) Abdominal Aortic Aneurysm Screening Programme (NAAASP) show that, over a seven-year period, the turn down rate after referral for treatment with a screen-detected AAA and perioperative mortality...
New data on asymptomatic carotid disease, key developments in below-the-knee (BTK) interventions, and evidence to suggest wearable activity monitors could benefit intermittent claudication patients all feature in our top 10 most read stories of February 2021.
1. New data find...
The Zenith fenestrated+ endovascular graft (ZFEN+) product (Cook Medical) has received breakthrough device designation from the US Food and Drug Administration (FDA). This designation is granted for devices that have the potential to provide more effective treatment or diagnosis...
FlowOx therapy (Otivio) delivered as a single annual dose may be a cost-effective treatment for peripheral arterial disease (PAD), a recent study published in PLOS ONE reports. The authors, Victory Ezeofor (Centre for Health Economics and Medicines Evaluation, Bangor...
In this supplement, sponsored by Cydar:
Tom Carrell, Cydar Medical executive director and co-founder, gives an overview of the company’s Cydar EV software
Charles J Bailey details how Cydar EV has allowed a US vascular centre's endovascular aortic practice to evolve and...
Positive results from a comparative-effectiveness study involving transcarotid artery revascularisation (TCAR) have been published in JAMA Network Open, Silk Road Medical have announced.
The study found the availability of TCAR at a hospital was associated with a significant decrease in...
Ireland’s largest growth capital investor—BGF—has completed a €6 million equity investment in Vasorum Limited.
Vasorum is a Dublin based business specialising in devices used to close arterial punctures in vascular, cardiology, radiology and neuroradiology procedures. Based in Dublin, the company...
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Tobias Steinke (Düsseldorf, Germany), Matteo Tozzi (Varese, Italy) and Robert Shahverdyan (Hamburg, Germany) give their reactions to the publication in the New England Journal of Medicine...
A US Food and Drug Administration (FDA) advisory panel has recommended against premarket approval of BD’s Lutonix 014 drug-coated balloon (DCB) for use in below-the-knee (BTK) arteries. In a meeting on 17 February, the majority of the FDA Cardiovascular...
Terumo Corporation has signed a definitive agreement to acquire all assets of Health Outcomes Sciences, a specialist in predictive analytics and clinical decision support for healthcare organisations.
“The acquisition of Health Outcomes Sciences and the ePRISM platform expands Terumo’s presence...
In patients with aortic dissection, a retrospective, population-based cohort study suggests that aortic branch involvement is responsible for “a significant long-term morbidity, without any related mortality”. This finding was recently published online in the Journal of Vascular Surgery (JVS)....
Access Vascular has announced US Food and Drug Administration (FDA) clearance of its HydroMID midline catheter.
A press release from the company states that HydroMID, which is made of Access Vascular’s proprietary biomaterial that has been shown to reduce...
Acute kidney injury is a common complication after intervention for peripheral arterial disease (PAD), and is associated with “medium-term mortality” following percutaneous transluminal angioplasty (PTA), a new study in the British Journal of Surgery (BJS) finds. Authored by Emmanuel...
Soundbite Medical Solutions has announced Health Canada approval for the SoundBite Crossing System – Peripheral (SCS-P) with the 0.014” Active Wire (14P).
The SCS-P (14P) is intended for the treatment of patients suffering from peripheral arterial disease (PAD) with heavily...
On the 3 February, the National Institute for Health and Care Excellence (NICE) Medical Technologies Advisory Committee approved the use of Leukomed Sorbact (Essity) for the prevention of surgical site infections.
The dressing works by binding bacteria to the...
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Ralf Langhoff (Berlin, Germany) talks to Vascular News about the 12-month data from the CONSEQUENT study, which aims to assess the safety and efficacy of the SeQuent®...
Reporting a strong association between asymptomatic carotid stenosis and future stroke risk, Dominic Howard (Oxford University Hospitals NHS Trust, Oxford, UK) and colleagues write in The Lancet Neurology that their findings are “contrary to the assumptions of current guidelines...
The CLI Global Society is launching the first peer-reviewed academic journal focusing on interventional techniques pertaining to critical limb ischemia (CLI). The new journal, Journal of Critical Limb Ischemia, is launching in the spring of 2021.
According to the CLI...
The CLI Global Society is launching the first peer-reviewed academic journal focusing on interventional techniques pertaining to critical limb ischemia (CLI). The new journal, Journal of Critical Limb Ischemia, is launching in the spring of 2021.
According to the CLI...
Medtronic has voluntarily issued a global recall of its Valiant Navion thoracic stent graft system and informed physicians to immediately cease use of the device until further notice.
In accordance with its commitment to patient safety—and in consultation with independent...
Front Line Medical Technologies has received Health Canada approval for its COBRA-OS (Control of bleeding, resuscitation, arterial occlusion system) device after three years of research and development. The COBRA-OS is an aortic occlusion device with a low-profile for temporary...
Raghu Kolluri (Columbus, USA) talks to Vascular News about a recent comparative study looking at differences between in-tack and in-stent restenosis. The study examined data from the TOBA II trial–specifically 28 patients who had received some form of reintervention–with...
PatenSee has initiated a first-in-human clinical trial to assess its machine vision-based surveillance system, a press release from the company reveals. The trial, led by Benaya Rozen-zvi, director of the Institute for Nephrology and Hypertension at Rabin Medical Center...
A new report finds the role of vascular surgeons may be underappreciated and suggests that an investment in the profession will provide a substantial return for the US healthcare system.
The Society for Vascular Surgery (SVS) has published 'The value...
One-year findings of the CONSEQUENT all-comers observational study of the paclitaxel drug-coated balloon (DCB) SeQuent Please OTW (B Braun) were reported at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online). Principal investigator Ralf Langhoff (Sankt Gertrauden Krankenhaus, Berlin,...
“Using an objective system that discriminates between aetiology and outcome allows a more complete, objective understanding of relative infection risks and outcomes for arteriovenous grafts (AVGs).” This is the conclusion of a review published online in The Journal of...
Researchers from the University of Missouri School of Medicine have discovered that while endovascular aneurysm repair (EVAR) is more commonly utilised for ruptured abdominal aortic aneurysms (rAAA), shortens hospital stay, and has a lower initial mortality rate, the odds...
Among individuals with “significant vascular surgical pathology,” John Houghton (University of Leicester, Leicester, UK) and colleagues have found that the prevalence of cognitive impairment is high and is associated with worse postoperative delirium (POD). Therefore, they suggest that screening...
Kenneth Rosenfield (Boston, USA) speaks to Vascular News about the TRANSCEND trial, a non-inferiority randomised controlled trial, which looked to demonstrate safety and efficacy of the lower-dose third-generation SurVeil drug-coated balloon (DCB; Surmodics) when compared with the IN.PACT Admiral DCB (Medtronic)...
Michel Reijnen (Arnhem, Netherlands) talks to Vascular News about the four-year IN.PACT Global study results, focusing on the 156 patients in the study who had critical limb ischaemia (CLI). These patients had a mean lesion length of 40 centimetres...
There is some evidence to indicate that the inclusion of wearable activity monitors in home-based exercise therapy improves walking ability and quality of life in patients with intermittent claudication. This is the main finding of a systematic review that...
Soundbite Medical Solutions has announced Health Canada approval for the SoundBite Crossing System – Peripheral (SCS-P) with the 0.014” Active Wire (14P).
The SCS-P (14P) is intended for the treatment of patients suffering from peripheral arterial disease (PAD) with heavily...
MedAlliance has announced enrolment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon Selution SLR for the treatment of patients with peripheral arterial disease (PAD). Selution SLR is a novel sirolimus-eluting balloon that...
New clinical evidence for the use of the Luminor drug-coated balloon (DCB; iVascular) in complex lesions with long-term follow-up has been presented on the main session of the Leipzig Interventional Course 2021 (LINC; 25–29 January, online). These outcomes show...
In a late-breaking trial session at LINC 2021 (The Leipzig Interventional Course, 25–29 January, online), key updates on below-the-knee (BTK) interventions were in the spotlight. Speaking during his presentation of the 12-month data from the PROMISE I early feasibility study of the LimFlow...
In a late-breaking trial session at LINC 2021 (The Leipzig Interventional Course, 25–29 January, online), key updates on below-the-knee (BTK) interventions were in the spotlight.
Francesco Liistro (Azienda Usl Toscana Sud Est, Arezzo, Italy) presented nine-month outcomes from the IN.PACT...
In a recommendation statement published on 2 February in The Journal of the American Medical Association (JAMA), the US Preventive Services Task Force (USPSTF) advises against screening for asymptomatic carotid artery stenosis in the general adult population. This recommendation...
Transit Scientific has announced the close of its Series A financing round. The round was led by a large multinational investor and joined by previous seed investors.
Transit Scientific achieved US Food and Drug Administration (FDA) clearances and multicentre,...
There is some evidence to indicate that the inclusion of wearable activity monitors in home-based exercise therapy improves walking ability and quality of life in patients with intermittent claudication. This is the main finding of a systematic review that...
From her initial exposure to the field of vascular surgery as an intern to becoming the first female president of the Society for Vascular Surgery in 2013, Julie Ann Freischlag speaks to Vascular News about her career so far....
Six-month results of the Lutonix arteriovenous (AV) Global registry were recently published in the Journal of Vascular and Interventional Radiology (JVIR). The data confirm that the Lutonix 035 drug-coated balloon (DCB) catheter (BD) is safe and effective in real-world...
José L Soriano (University of Granada, Granada, Spain) and colleagues propose a strategy for the wound healing of burns in Pharmaceutics that combines the antioxidants vitamins A, D, E with the endogenous pineal hormone melatonin (MLT), all loaded into...
Specialised oral nutritional supplement can be a therapeutic option for hard-to-heal wounds, conclude Adriano A Mehl (Universidade Tecnológica Federal do Paraná, Curitiba, Brazil) and colleagues in the Journal of Wound Care.
“Hard-to-heal wounds represent a silent epidemic,” Mehl et...
Cardiovascular Systems (CSI) has partnered with Chansu Vascular Technologies (CVT) to develop novel peripheral and coronary everolimus drug-coated balloons (DCBs).
Under the terms of the agreements, CSI will provide milestone-based financing to CVT for the development of the DCBs. Under...
The Approach Authority Workhorse microwire guide (Cook Medical) is now commercially available in the USA and Canada.
Designed as an 0.018-inch diameter workhorse wire guide, Approach Authority can be used for multiple purposes in the same procedure.
A company press release...
The German Institute for Hospital Remuneration (InEK) has renewed the new examination and treatment methods (NUB) Status 1 designation of VasQ external support (Laminate Medical Technologies) for 2021.
NUB Status 1 provides supplemental reimbursement for innovative medical devices that...
Cagent Vascular announced the results of its PRELUDE-BTK study at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online). The PRELUDE-BTK study was a prospective, single-arm, multicentre feasibility study to show the safety and efficacy of serration angioplasty.
The study...
Significant disparities in healthcare services in the USA result in unnecessary limb loss, stroke, and death. Vascular health professionals are developing new programmes to address these inequities through the Society for Vascular Surgery (SVS) Foundation.
The SVS Foundation Volunteers In...
BD today announced that new clinical data have found robust evidence that using a vascular care solution can help improve outcomes for patients requiring peripheral intravenous catheters (PIVCs).
Results of the CLEAN3 trial, published in The Lancet Infectious Diseases, showed...
Piur Imaging has launched its remote image analysis platform, called Piur Remote Expert, for research users. It is a solution to perform remote image analysis of tomographic three-dimensional (3D) ultrasound images, including carotid plaque analysis and abdominal aortic aneurysm...
Recent data from the investigator-initiated, randomised controlled trial (RCT), BIOLUX AV, showed that the treatment of dysfunctional haemodialysis access with Biotronik's Passeo-18 Lux drug-coated balloon (DCB) is safe and effectively prevents access failure.
Patients (n=120) with dysfunctional haemodialysis access underwent...
Following recent approval by the US Food and Drug Administration (FDA) of the Treo abdominal aortic stent graft system for the treatment of patients with abdominal aortic aneurysms (AAA), Terumo Aortic has announced the publication of the primary endpoint...
Terumo Aortic has announced completion of enrolment of the RelayPro traumatic injury (RelayPro-T) investigational device exemption (IDE) study in the USA. RelayPro is a low-profile thoracic stent graft device designed to expand the treatment of thoracic endovascular aortic repair...
Sabine Steiner (Leipzig, Germany) talks to Vascular News about the 24-month results from the COMPARE trial – which were presented at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online) – a trial which compared a low dose paclitaxel-coated...
A key theme among the late-breaking trial data presented at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online) was the emergence of long-term evidence on paclitaxel devices in the femoropopliteal segment. Results out to five years shows good...
New data presented for the first time at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online) support the use of drug-coated balloons (DCBs) as a treatment for dysfunctional arteriovenous fistulas (AVFs). The audience also heard the case for...
Royal Philips has introduced the Philips Abdominal Aortic Aneurysm (AAA) Model, providing physicians a more patient-friendly solution compared to the current standard of care for managing AAA patients. Based on 3D ultrasound, the Philips AAA Model delivers clinicians accurate diagnostic...
Twelve-month results from the PRESTIGE below-the-knee (BTK) study have been presented as a late-breaking trial at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online). The objective of this clinical investigation has been to evaluate safety and performance outcomes...
Artio Medical recently announced that it has successfully completed the first human use of its Amplifi vein dilation system. The first clinical procedure was performed by Adrian Ebner, head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asuncion,...
VentureMed Group announced today that data from three studies evaluating the use of its Flex Vessel Prep (VP) system were presented during LINC 2021 (The Leipzig Interventional Course; 25–29 January, online). The Flex VP system is designed to modify...
Data from two head-to-head trials on drug-eluting technologies in femoral artery treatment were presented during a late-breaking session at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online)—one-year TRANSCEND and two-year COMPARE results. Both studies point to the non-inferiority...
The US Food and Drug Administration (FDA) has granted Pedra Technology a breakthrough device designation for the periprocedural use of the company’s Pedra Xauron perfusion system in the treatment of critical limb-threatening ischaemia (CLTI).
CLTI is a severe form of...
The US Food and Drug Administration (FDA) has granted Pedra Technology a breakthrough device designation for the periprocedural use of the company’s Pedra Xauron perfusion system in the treatment of critical limb-threatening ischaemia (CLTI).
CLTI is a severe form of...
Royal Philips has announced the final, five-year results of two randomised controlled trials (RCTs) that show no difference in all-cause mortality between patients treated with the Stellarex drug-coated balloon (DCB) and those treated with percutaneous transluminal angioplasty (PTA), the...
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In this supplement, sponsored by Medtronic:
From a bailout procedure to a standardised therapeutic option: Ten-year anniversary of the first publication of abdominal use of ChEVAR in...
Bart Dolmatch (Portola Valley, USA) talks to Vascular News about some of the key data highlights from the 24-month AVeNEW trial, which compared the safety and efficacy of the Covera™ Vascular covered stent (BD) against percutaneous transluminal angioplasty (PTA) for the treatment...
The European Society for Vascular Surgery (ESVS) has produced a clinical practice guidelines document on the management of venous thrombosis—the first guidelines the society have produced on this topic. The document was published as an Editor’s Choice paper in...
Social vulnerability contributes considerably to the probability of hospitalisation among individuals with COVID-19 and diabetes with associated comorbidities. This is the conclusion of a recent cross-sectional study, published in Diabetes Care, from Sandra G Sosa-Rubí (Center for Health Systems...
A systematic review published in Wound Management and Prevention did not find evidence of the in vivo effectiveness of Plantago major—a medicinal plant that has been used for centuries to treat various health conditions, including wounds— for wound healing....
A recent analysis by finds an association between depression and non-home discharge after revascularisation for chronic limb-threatening ischaemia (CLTI). Authors Joel L Ramirez, James C Iannuzzi (University of California, San Francisco, San Francisco, USA) and colleagues write in an...
W L Gore & Associates (Gore) recently announced that the US Food and Drug Administration (FDA) has granted regulatory approval for the new Gore Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis with Active Control system.
According to a press release,...
In this issue:
Silent brain infarction common after endovascular arch repair, STEP registry finds (p. 1)
"From pioneering times to a mature technology": The evolution of bridging stents for fenestrated and branched endovascular aneurysm repair (F/BEVAR) (p. 14)
Vascular...
In this issue:
Silent brain infarction common after endovascular arch repair, STEP registry finds (p. 1)
"From pioneering times to a mature technology": The evolution of bridging stents for fenestrated and branched endovascular aneurysm repair (F/BEVAR) (p. 14)
Vascular...
Nephrology Associates of Northern Illinois and Indiana (NANI), the largest nephrology group in the USA, is the first practice in Illinois to adopt the Ellipsys vascular access system (Avenu Medical, now part of Medtronic), a technology for patients with end-stage renal disease (ESRD) who require haemodialysis...
It was recently announced that a 2021 Advanced Training Statement on Vascular Medicine, co-authored by the American College of Cardiology (ACC), the American Heart Association (AHA), the Society for Vascular Medicine (SVM), and the American College of Physicians (ACP),...
Reflow Medical introduces the low-profile Spex LP 0.014 and 0.018-inch reinforced support catheters.
According to the company, the Spex LP is designed with a low-profile tip for accessing and crossing the "tightest and most complex lesions" with a supportive system....
The US Food and Drug Administration (FDA) has granted premarket approval (PMA) for the Woven EndoBridge (WEB) 17 system from MicroVention, a US-based subsidiary of Terumo. This is a new addition to the WEB aneurysm embolization system for the...
A trio of vascular experts including Raphaël Coscas (Paris, France), Alexandros Mallios (Paris, France) and Kate Steiner (Stevenage, UK) discuss the key findings of the IN.PACT™ AV Access trial–which was recently published in the New England Journal of Medicine...
Results from the EXTRACT-PE trial, which found that Penumbra’s Indigo aspiration system met its predefined safety and efficacy endpoints for the treatment of pulmonary embolism (PE), have been published in JACC: Cardiovascular Interventions.
Penumbra’s Indigo system is designed to remove...
“Investment in maternity services research is essential for our understanding of the extent of wound-related complications for the postpartum mother and improved clinical pathways for wound management,” write Charmaine Childs (Sheffield Hallam University, Sheffield, UK), Kylie Sandy-Hodgetts (University of...
There are several covered stents on the market that are used in an off-label setting as bridging stents for fenestrated and branched endovascular aneurysm repair (F/BEVAR). Currently, there is no consensus on when to use what—no gold standard, no...
Angus Watson (Edinburgh, UK) talks to Vascular News about the importance of simulation as a safe and effective way to get trainees’ skills “up to speed”. Simulation should be used much more regularly than is currently the case, argues...
Preliminary results from the STEP (Stroke from thoracic endovascular procedures) registry show that silent brain infarction following endovascular repair of the aortic arch is frequent, with postoperative diffusion weighted magnetic resonance imaging (DW-MRI) demonstrating an incidence of 50%.
As...
Mermaid Medical Group recently announced US commercial availability of the D-Clot HD rotational thrombectomy system. As of 12 January, the company reports 25 successful human cases.
‘‘I am extremely pleased to see dialysis patients who are heavily involved with the...
Endospan has announced the first implant of its Nexus aortic arch stent graft system on a patient in Norfolk, USA, with a thoracic aortic aneurysm as part of the TRIOMPHE investigational device exemption (IDE) study.
The TRIOMPHE study is a...
A recent study concludes that arterial diameter may influence arteriovenous fistula (AVF) aneurysm progression and the interval to surgical revision. “Patients with larger arterial diameters should be monitored closely and referred early after aneurysm development,” authors Alexis M Cahalane...
Preoperative frailty is associated with a significantly increased long-term mortality after elective vascular surgery. This is the conclusion of Louise BD Banning (University of Groningen and University Medical Center Groningen, Groningen, The Netherlands) and colleagues in an online Journal...
This advertorial is sponsored by Bentley.
Treatment of penetrating aortic ulcers (PAUs) has been swayed by recent advances in endovascular aneurysm repair (EVAR). Anecdotally, the majority of diagnosed PAUs are treated by endovascular techniques rather than by open surgery, and...
Following the publication of the SWEDEPAD interim analysis, Andrew Farb, Misti Malone, and William H Maisel, representatives of the Center for Devices and Radiological Health, US Food and Drug Administration (FDA), have authored a perspective piece in the New...
VasQ, a high haemocompatibility biosynthetic vascular device from Laminate Medical Technologies, could be protective against the haemodynamic modifications that occur during arteriovenous fistulae (AVF) creation, a recent article in The Journal of Vascular Access reports. Roberto Palumbo (Saint Eugenio...
Ruth Benson (Birmingham, UK) and Sandip Nandhra (Newcastle, UK) speak to Vascular News about their presentation on the COVID-19 Vascular Service (COVER) study, which aims to evaluate the evolving impact of the COVID-19 pandemic on vascular practice, using a...
Diabetes Care has published a summary of revisions made to the Standards of Medical Care in Diabetes—2021.
“The field of diabetes care is rapidly changing as new research, technology, and treatments that can improve the health and well-being of...
Remote wound assessment undertaken by physicians is as effective through an artificial intelligence (AI) medical device as bedside examination, a new study published in the Journal of Wound Care concludes. In an investigation of the non-invasive, AI-powered, portable Wound...
A recent network meta-analysis shows that, in failing arteriovenous fistulas (AVFs) with outflow stenosis, drug-coated balloon (DCB) angioplasty is “significantly superior” to plain balloon angioplasty, presenting an improved six-month failure rate. However, Gregory Tripsianis (Democritus University, Alexandroupolis, Greece) and...
According to the AMBUVASC randomised controlled trial (RCT), outpatient hospitalisation is not cost-effective compared with inpatient hospitalisation for endovascular repair of patients with claudication at a €50,000/quality-adjusted life year (QALY) threshold. Yann Gouëffic (Groupement Hôpitalier Paris St Joseph, Paris,...
A retrospective study analysing approximately 55,000 patients undergoing abdominal aortic aneurysm (AAA) repair suggests current screening guidelines may be inadequate in detecting a significant number of new cases. Additionally, expanding screening for certain population segments may be warranted. The...
Exercise can play an important role in treating peripheral arterial disease (PAD), a recent review from Amy Harwood (Centre for Sport and Exercise Life Sciences, Coventry University, Coventry, and the Faculty of Health Sciences, University of Hull, Hull, UK)...
The Society for Vascular Surgery (SVS) has shifted the 2021 iteration of its flagship conference, the Vascular Annual Meeting (VAM), to August in a bid to increase the likelihood of an in-person event.
The meeting was originally scheduled to take place...
Nicholas Inston (Birmingham, UK; moderator) is joined by Jose Ibeas (Barcelona, Spain), Panagiotis Kitrou (Patras, Greece) and Tobias Steinke (Düsseldorf, Germany), for a special Vascular News webinar called ‘WavelinQ™ 4F EndoAVF System – An attractive non-surgical AV fistula option for...
Speaking at the Virtual Aortic Surgery How to Do It (HTDI) Highlights conference (17–18 December), Stéphan Haulon (Hôpital Marie Lannelongue, GHPSJ, Paris, France) discussed total endovascular treatment of the aortic arch in chronic dissections. Detailing global experience using three-vessel...
Okami Medical has revealed the expansion of its LOBO vascular occlusion system product line with US Food and Drug Administration (FDA) 510(k) clearance of the LOBO-5 vascular occluder.
According to a press release from the company, the LOBO (Low-profile braided...
Centerline Biomedical recently announced completion of the first surgical case in the MOTION clinical study of the company's intraoperative positioning system (IOPS) surgical navigation platform. The technology has been cleared by the US Food and Drug Administration (FDA) and...
A recent systematic review found that “carefully designed and structured” simulation-based training (SBT) in open vascular surgery is effective and can improve technical skills, especially in less experienced trainees. However, authors Jonathan Lawaetz (Rigshospitalet, Copenhagen, Denmark) and colleagues note...
Veryan Medical recently announced that the first patient has been enrolled in the MIMICS-3 USA study by John H Rundback at NJ Endovascular & Amputation Prevention (Clifton, USA).
Nick Yeo, Veryan's CEO commented, "We are enormously grateful to Dr Rundback...
Remote ischaemic conditioning is a “really innovative technology” that can be used as an adjunctive therapy to significantly reduce tissue damage from an interrupted blood supply, Matthew Regulski (medical director, The Wound Institute of Ocean County New Jersey; partner,...
In a win for proponents of topical oxygen therapy, co-principal investigator of the TWO2 study—a multinational, multicentre, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of cyclical topical wound oxygen therapy in the treatment of chronic diabetic foot ulcers—Robert...
Corindus has announced today global launch of a new set of automated robotic movements in the technIQ Series designed for the CorPath GRX system. The company received 510(k) clearance from the US Food and Drug Administration (FDA) for new...
Windy Cole (director of Wound Care Research, Kent State University College of Podiatric Medicine, Cleveland, USA) presented the first case—to her knowledge—to document healing in a calciphylaxis wound with the use of continuous topical oxygen therapy (cTOT) at the...
“Diabetic foot ulcers are very difficult to treat, and the approach should be multi-factorial,” Andrew Applewhite tells iWounds News. “If you do not offload a diabetic foot ulcer, if you do not treat any infection present, if you do...
Reviewing the evidence in the published literature for the use of topical haemoglobin spray in wound healing, Paul Chadwick proposes Granulox (Mölnlycke) is a safe, efficacious, and cost‑effective topical oxygen therapy for a range of chronic, hard‑to-heal wounds, and...
Thomas Serena, principal investigator of the recently completed Natrox clinical trial—a randomised controlled multicentre trial examining the effect of topical oxygen wound therapy on the healing rate of chronic diabetic foot ulcers—provides an overview of the pros and cons...
Efemoral Medical has announced the first-in-human (FIH) use of the company's Efemoral vascular scaffold system (EVSS) with FlexStepv technology in the EFEMORAL I FIH clinical study. According to a press release, this technology offers a new approach to treat...
The largest mobile wound care provider in the US Midwest, Wound Care Plus, has adopted the MolecuLight i:X point-of-care imaging device (MolecuLight) to be included as part of its standard of care services offered to the long-term care and...
Athanasios Saratzis (Leicester, UK) speaks to Vascular News about his lecture at VSASM 2020 (Vascular Societies’ Annual Scientific Meeting; 24–27 November, Virtual) on renal injury in major endovascular surgery, arguing that acute kidney injury (AKI) and chronic renal decline...
An unplanned interim analysis of the registry-based SWEDEPAD clinical trial, in which patients with peripheral arterial disease received treatment with paclitaxel-coated (drug-coated balloons or drug-eluting stents) or uncoated endovascular devices, “did not show a difference between the groups in...
Roberto Chiesa (Milan, Italy) warmly invites delegates to the 2020 virtual edition of the How To Do It (HTDI conference; 17–18 December, virtual with complimentary registration), where top international speakers will focus on type B aortic dissection, aortic arch...
Alucent Biomedical has announced Stanford vascular surgeon Venita Chandra (Stanford University Medical Center, Stanford, USA) will join the company’s scientific advisory board. The news comes as Alucent seeks to expand its clinical trial portfolio beyond the treatment of peripheral...
According to Daniela Branzan (University Hospital Leipzig, Leipzig, Germany) and colleagues, pre-emptive embolisation of aneurysm sac side branches for patients with abdominal aortic aneurysm (AAA) is “safe and effective” in preventing type II endoleak after endovascular aneurysm repair (EVAR)...
Shockwave Medical has announced that as part of the calendar year 2021 Medicare Hospital Outpatient Prospective Payment System (OPPS) final rule, the Centers for Medicare & Medicaid Services (CMS) has created four new codes for intravascular lithotripsy (IVL) procedures...
Hypercoagulability in COVID-19 patients leads to an increase in the malfunction rate of temporary haemodialysis catheters—but heparin locking of the catheters is linked to decreased malfunction rates. Those are among the main findings of a study recently published in...
Terumo Aortic has announced the midterm results from the RelayPlus thoracic stent graft system post-approval study, revealing low operative mortality and morbidity—supporting its use as a “safe and effective” thoracic aortic aneurysm treatment.
The RelayPlus thoracic stent graft system is...
Mo Hamady discusses developments in aortic stent grafts in recent years, and offers a contemplation on the complications associated with endovascular aneurysm repair (EVAR). Despite advances in stent graft technology, operator knowledge, and physician experience in recent years, he...
There is no evidence of a benefit from additional paclitaxel-coated balloon use compared to standard balloon angioplasty alone in the context of preserving arteriovenous (AV) fistula patency for haemodialysis, according to as-yet unpublished data from the multicentre, randomised controlled...
B Braun has revealed that 12-month results from the LOCOMOTIVE EXTENDED study of the company’s Multi-Loc multiple stent delivery system have been published in Vasa: European Journal of Medicine. The study authors, Klaus Amendt (Diakonissenkrankenhaus Mannheim, Mannheim, Germany) and...
In a survey conducted by St George’s Vascular Institute (London, UK) on the willingness of patients in South London to attend abdominal aortic aneurysm (AAA) surveillance during the COVID-19 pandemic, just under 60% of patients said they would attend...
Based on the findings of their first-in-human feasibility study, Joost van Herwaarden (Utrecht University Medical Centre, Utrecht, The Netherlands) and colleagues write in the European Journal of Vascular and Endovascular Surgery (EJVES) that Philips’ Fiber Optic RealShape (FORS) technology...
Vesper Medical recently announced initiation of its US Food and Drug Administration (FDA) investigational device exemption (IDE) study—VIVID (Venous stent for the iliofemoral vein investigational clinical trial using the Vesper Duo venous stent system).
The VIVID trial is a prospective, multicentre, single-arm...
In their recent systematic review and meta-analysis, Venkata Sai Jasty (University of Arizona, Tuscon, USA) and colleagues found that the risk of ischaemic steal syndrome, “one of the most feared complications in vascular access,” and patency rate are comparable...
“Simple changes can allow for an effective vascular limb salvage service to continue during the extremes of the pandemic,” Andrew Nickinson (University of Leicester, Leicester, UK) informed the virtual audience of the 2020 UK Vascular Societies’ Annual Scientific...
Based on data collected from 2002–2020, Dominic Howard (Oxford University Hospitals NHS Trust, Oxford, UK) spoke at the 2020 UK Vascular Societies’ Annual Scientific Meeting (VS ASM; 24–27 November, virtual) on changing patterns of thoracic aortic disease. He stressed...
In a study of interface pressure changes under compression bandages, Junjie Ning, Fedor Lurie (both Jobst Vascular Institute, Toledo, USA), and colleagues found that while pressure decreased over time under all studied bandages, the temporal pattern of pressure change...
MedAlliance has announced completion of patient enrolment in the ISABELLA clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of dysfunctional arteriovenous (AV) fistulas in end-stage renal failure patients undergoing haemodialysis.
Selution SLR (sustained limus...
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Robert Lookstein (New York, USA; principal investigator) and Andrew Holden (Auckland, New Zealand; principal investigator) discuss the key six-month results and implications from the IN.PACT™ AV...
This year's Vascular Interventional Advances annual meeting (VIVA 2020; 6–8 November, online) opened with a session on controversial hot topics and advanced multidisciplinary approaches to vascular disease. Looking back on the paclitaxel “debacle”, Peter Schneider (University of California San...
Penumbra today announced US Food and Drug Administration (FDA) 510(k) clearance for expanded indication of the latest iteration of the Indigo aspiration system, Lightning 12.
As part of the Indigo aspiration system, Lightning 12 (Indigo system CAT 12 aspiration catheter...
The Society of Vascular and Interventional Neurology (SVIN) colleagues and James Siegler (Cooper University Hospital, Camden, USA) identify that it should come as no surprise that the COVID-19 pandemic and its many "waves" has led to significant paradigm shifts in...
A recent systematic evaluation of the costs of elective endovascular aneurysm repair (EVAR) and open infrarenal abdominal aortic aneurysm (AAA) repair implies cost equivalence. This is the conclusion of Ruth M A Bulder (Leiden University Medical Centre, Leiden, The...
Amy Ferris (Geriatric and General Medicine Cardiff, Cardiff, Wales, UK), Keith Harding (Welsh Wound Innovation Centre, Ynysmaerdy, Wales, UK), and colleagues have landed on a “suitable protocol” for measuring serum and wound fluid iron levels in the context of...
A prospective, randomised controlled crossover study (NCT03662997) comparing three multi-layered silicone foam dressings for the management of chronic wounds finds Mepilex Border Flex (Mölnlycke Health Care, the study’s sponsors) to be statistically superior in terms of wear after one...
Patient-centred clinical success after lower-extremity revascularisation for people with diabetic foot wounds was achieved among 63% of patients in a new analysis—but researchers suggest the measure on which the study was based may define clinical success too strictly given...
The Infinity Angioplasty Balloon Company announced today that its angioplasty balloon platform—the Infinity angioplasty balloon catheter—has successfully completed a first-in-human clinical trial.
The platform was recently cleared by the US Food and Drug Administration (FDA) for percutaneous transluminal angioplasty (PTA)...
Sinomed has announced the presentation of data from its inter-continental PIONEER III study comparing the safety and efficacy of the Supreme HT (healing-targeted) drug-eluting stent (DES), to the Xience (Abbott) or Promus durable polymer stent (Boston Scientific). One-year results...
Sean Lyden (Cleveland, USA), current VIVA Board president, speaks to Vascular News about his two years at the helm, which began with the “controversy on paclitaxel” and has led right up to COVID-19 and the first virtual VIVA meeting. Ten...
At this year’s European Society for Vascular Surgery (ESVS) annual meeting (ESVS Month; 29 September–29 October, virtual), the Vascular Low Frequency Disease Consortium (VLFDC) was a topic of discussion. Based on a presentation given at the meeting, Christian-Alexander Behrendt,...
According to a press release, Transit Scientific's XO Score system has been successfully used to dilate multiple challenging fibrotic and calcific lesions in haemodialysis patients with stenotic and occluded fistulas. Richard Saxon (Tri City Medical Center Medical Center, Oceanside,...
AngioDynamics has announced the safety and efficacy results from the RAPID (Registry of AngioVac system procedures in detail) database. Results were shared by principal investigator John Moriarty (University of California Los Angeles , Los Angeles, USA) at this year's...
Moderate-to-severe calcification in peripheral arteries is an “ongoing battle” in in the endovascular treatment of complex lesions, William Gray (Philadelphia, USA), tells Vascular News.
Gray explains that there are a number of tools deployed to win the acute battle, but notes frankly that they...
“There has been a steady change in the approach and care of pulmonary embolisms that has been noted over the last five to seven years in the US, but also worldwide, and that seems to be spear-headed by a...
KitoTech Medical has been awarded a group purchasing agreement for non-invasive skin closure devices with Premier. Effective since 1 November, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by...
Treatment with the mVASC microvascular tissue graft product (MicroVascular Tissues) results in superior wound closure compared to standard of care alone, the first randomised controlled trial using microvascular elements to treat microvascular dysfunction—the HIFLO trial—finds. Presented at the Symposium...
Surmodics recently announced that six-month data from the AVESS first-in-human (FIH) study of the company’s Avess arteriovenous fistula (AVF) drug-coated balloon (DCB) was shared at this year's Vascular Interventional Advances virtual conference (VIVA 2020; 6–8 November, virtual).
The AVESS study...
The Absorb bioresorbable vascular scaffold (BVS; Abbott Vascular) can be used for the treatment of chronic limb-threatening ischaemia (CLTI) patients in infrapopliteal arteries with no safety concerns and favourable patency, rates of reinterventions, and amputations at a mid-term follow-up...
During a late-breaking data session at this year’s Vascular Interventional Advances annual meeting (VIVA 2020; 6–8 November, virtual), Ehrin Armstrong (University of Colorado, Denver, USA) presented two-year outcomes from the DETOUR I trial for percutaneous femoropopliteal bypass. He reported...
Concept Medical has announced the enrolment of the first patient in the SirPAD (Sirolimus in peripheral arterial disease) trial. According to a press release, SirPAD is the first all-comer randomised controlled clinical trial (RCT) investigating major adverse limb events...
Recent data from VOYAGER PAD showed no association between drug-coated device (DCD) use and mortality. Given the absence of a safety signal, the current analysis examined the potential benefit of DCD versus non-DCD treatment for reducing limb outcomes. Connie...
The DISRUPT PAD III randomised controlled trial (RCT) provides the largest level one evidence for the treatment of heavily calcified femoropopliteal arteries, noted William Gray (Main Line Health, Philadelphia, USA) during the second and final late-breaking data session at...
Royal Philips today announced the results of a patient-level meta-analysis that confirms the safety profile of its Stellarex drug-coated balloon (DCB) at four years. Including data from two major randomised controlled trials (RCTs), the results show no difference in...
Anthony Comerota (Alexandria, USA), global principal investigator of the VIVO trial, discusses the highlights of the 12-month results of the VIVO clinical study that were presented at VIVA 2020.
While the safety and efficacy of the Zilver Vena stent, which...
Krishna Rocha-Singh (Springfield, USA) speaks to Vascular News about his presentation at VIVA20 (Vascular Interventional Advances; 6–7 November 2020; virtual) on the REALITY study, which examined the safety and efficacy of directional atherectomy combined with drug-coated balloon to treat...
LimFlow SA has announced the presentation of one-year data from the full patient cohort in its PROMISE I study of the LimFlow percutaneous deep vein arterialisation system, showing sustained positive outcomes for both amputation-free survival and complete wound healing....
Efthymios Avgerinos (University of Pittsburgh, Pittsburgh, USA) presented results from the SUNSET sPE trial during a late-breaking data session at this year’s Vascular Interventional Advances conference (VIVA 2020; 6–8 November, virtual). His concluded that catheter thrombolysis is safe and...
In a late-breaking data session at this year’s Vascular Interventional Advances conference (VIVA 2020; 6–8 November, virtual) Thomas Zeller (University Heart Center Freiburg, Bad Krozingen, Germany) presented new data from the IN.PACT Global study. Safety and efficacy of Medtronic’s...
Results of the VIVO clinical study support the safety and effectiveness of Cook Medical's recently FDA-cleared Zilver Vena venous stent for the treatment of symptomatic iliofemoral venous outflow obstruction, Anthony Comerota (Inova Fairfax Hospital, Alexandria, USA) revealed in a...
A vessel preparation treatment strategy of directional atherectomy prior to drug-coated balloon angioplasty with Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) in long, calcified femoropoliteal lesions is effective out to one year, with an acceptable safety profile. This was the...
In March 2020, the Vascular and Endovascular Research Network (VERN) launched the COVID-19 vascular service (COVER) study that is aimed at capturing the impact of the pandemic on global vascular surgery. Over half a year on, co-lead Sandip Nandhra...
This advertorial is sponsored by Bentley.
There are several covered stents on the market for both fenestrated endovascular aneurysm repair (FEVAR) and branched endovascular aneurysm repair (BEVAR). However, all are used off-label for these procedures, and there is currently no...
President of the Vascular Society for Great Britain and Ireland (VSGBI) 2019–2020 and avid climber Chris Imray discusses various aspects of his career. He considers how the field has changed, outlines his continued research into how the brain responds...
In this issue:
Second COVID-19 wave conveys continuing uncertainty for vascular surgery, conclude speakers at ESVS Month (p. 1 and p. 4)
"Starting to close the door on the paclitaxel controversy": Late-breaking trials presented at TCT 2020 (p. 1...
In this issue:
Second COVID-19 wave conveys continuing uncertainty for vascular surgery, conclude speakers at ESVS Month (p. 1 and p. 4)
"Starting to close the door on the paclitaxel controversy": Late-breaking trials presented at TCT 2020 (p. 1...
Boston Scientific announced it has received US Food and Drug Administration (FDA) approval of the Ranger drug-coated balloon (DCB), developed for the treatment of patients with peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal...
Vascular Barcelona Devices (VB Devices) recently announced that its Crabclamp product received CE mark approval as a Class 1s medical device.
According to a press release, the Crabclamp is a unique device that allows surgeons and their assistants to...
A new case report published in the Journal of Vascular Surgery (JVS) provides one of the first known opportunities to directly visualise the anastomosis that is created with Avenu Medical's Ellipsys vascular access system, a press release reveals.
"This is...
Based on the Janet Powell Honorary Lecture she gave at this year's European Society for Vascular Surgery annual meeting (ESVS Month; 29 September–29 October, virtual), Rebecka Hultgren details contemporary knowledge within the broad spectrum of aortic diseases, with specific...
During the prize session at this year’s European Society for Vascular Surgery annual meeting (ESVS Month, 29 September–29 October, virtual), Maaz Syed (University of Edinburgh, Edinburgh, UK) presented early clinical outcomes of a “promising multimodality imaging technique” in acute...
Data gathered from patients presenting with acute limb ischaemia (ALI) during the peak of the COVID-19 pandemic at the heart of New York City—a US epicentre—demonstrated a 50% rate of limb salvage as well as a 70% 30-day mortality...
RaFeVA (Rapid Femoral Vein Assessment), a new protocol, is a rapid and effective tool for the systematic ultrasound evaluation of the veins in the inguinal area and at mid-thigh, conclude Fabrizio Brescia (Unit of Anesthesia and Intensive Care Medicine,...
A specialist device that can remotely monitor the foot health of diabetes patients features in a new collaboration between the University of South Wales (USW) and healthcare systems company Thermetrix.
The Podium device examines the sole of the foot temperature...
NOTE: This supplement is only available to read in selected countries and geographies
In this supplement, sponsored by Medtronic:
Tobias Steinke outlines his treatment algorithm for the maintenance of arteriovenous (AV) dialysis access
In a discussion of the pathophysiology of...
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today it has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for a new indication to expand the use of Xarelto (rivaroxaban) in...
The Bashir Endovascular Catheter offers a safe and easy-to-use platform technology, creating immediate blood flow, accelerating thrombolysis, and dissolving large volumes of thrombus burden. This educational supplement, sponsored by Thrombolex, explores the use of various catheter-directed therapies, including their...
As 2020 draws to a close, many countries across the globe face continuing challenges arising from COVID-19. At this year’s European Society for Vascular Surgery (ESVS) annual meeting, held virtually as biweekly webinars as ESVS Month (29 September–29 October),...
The global advanced wound care market size is expected to reach US$15.59 billion by 2027, exhibiting a compound annual growth rate (CAGR) of 5.1% during the forecast period. The increasing cases of chronic wounds such as foot ulcers, pressure ulcers,...
Following a year of study and including more than 40 separate goals, objectives, and requested actions, the Society for Vascular Surgery (SVS) Executive Board has received, reviewed, and embraced the report of the SVS Diversity, Equity and Inclusion (DEI)...
VentureMed Group recently announced that the US Food and Drug Administration (FDA) cleared the company's Flex Vessel Prep system for use in the treatment of in-stent restenosis in the peripheral vasculature.
Within two years of undergoing stent implantation for femoropopliteal...
Karen Woo (Los Angeles, USA) speaks to Vascular News about the Vascular Low Frequency Disease Consortium (VLFDC) following her presentation at the 2020 European Society for Vascular Surgery (ESVS) annual meeting (29 September–29 October, virtual).
One of the problems the...
A multidisciplinary limb salvage alliance found that operating room (OR) and clinic volumes, as well as work relative value units (wRVUs), all increased significantly over a four-year period after the recruitment of podiatrists into the programme.
Studying data from...
Getinge is investing €3 million in its manufacturing of polyester grafts and patches to treat aneurysmal and occlusive diseases. The investment aims at increasing manufacturing capacity in Getinge’s site in La Ciotat, France.
“We have seen a growing demand from...
PolarityTE has announced it has received notification of being awarded a Phase I Small Business Innovation Research grant from the National Institutes of Health (NIH) for an application titled “Fluid Management System for Point of Care Device for Novel...
In its comments submitted to the Center for Medicare and Medicaid Services (CMS) in early October, the Alliance of Wound Care Stakeholders voiced its opposition to payment cuts from 5–9% for surgical procedures and 9% for physical therapy services...
Different risk factors affect patency between vascular access construction and the first percutaneous transluminal angioplasty, Mahoko Yoshida (Hiroshima University Hospital, Hiroshima, Japan) and colleagues conclude in the Journal of Vascular Access. Their results indicate that a poor patency rate is...
Based on a presentation given at the 2020 European Society for Vascular Surgery (ESVS) annual meeting (ESVS Month; 29 September–29 October, virtual), Karen Woo, Christian Behrendt, and Peter Lawrence detail a proposal for international collaboration in the study of...
In a recently-published study, Jeremy Crane (Imperial College Healthcare NHS Trust, Hammersmith Hospital, London, UK) and colleagues conclude that a 3mm-long arteriotomy may be routinely utilised for brachiocephalic fistula creation in an attempt to limit the incidence of steal...
Findings from a series of late-breaking trials in the endovascular field were presented recently at TCT Connect (14–18 October, virtual), the 32nd annual scientific symposium of the Cardiovascular Research Foundation (CRF). Sahil A Parikh (Columbia University Medical Center, New...
Endologix today announced the first implant of its Alto abdominal stent graft, commencing the European commercial release of the recently CE mark approved endograft.
“We are pleased to expand the product launch to include Europe, making Alto available to our...
Ra Medical Systems has announced enrolment of the tenth subject in its pivotal clinical trial to evaluate the safety and effectiveness of the Dabra excimer laser system as an atherectomy device for the treatment of peripheral arterial disease (PAD).
“Patient...
A new survey among vascular access (VA) and emergency department (ED) clinicians has revealed significant levels of variation in ultrasound-guided peripheral IV (UGPIV) practices and supply use across hospitals and alternate care settings. Published in the September issue of...
W L Gore & Associates recently announced that Bret Snyder, chair of the Gore board of directors, will succeed Jason Field in the role of president and CEO effective 9 October 2020. Jason will remain with the enterprise through...
MedAlliance has announced enrolment of the first two patients in the PRISTINE registry with Selution sustained limus release (SLR) 018 drug-eluting balloon (DEB) for the treatment of patients with below-the-knee disease. This is the first DEB accepted by the...
The Surfacer Inside-Out access catheter system device (Bluegrass Vascular) is safe and effective for patients with thoracic central venous obstruction requiring central venous access. That is conclusion of the prospective, multicentre SAVE (Surfacer system to facilitate access in venous...
A recent randomised controlled trial (RCT)—the CIPIC Rehab study—found that three-months’ community-based cardiac rehabilitation improves walking distance in patients with intermittent claudication. It was also found to improve physical activity level, diet, and health-related quality of life. These results...
R3 Vascular recently announced closing of its Series A financing round, including new equity investments of US$15 million and the conversion of US$2.8 million of convertible notes.
The round was led by an unnamed corporate investor and 415 CAPITAL,...
Reflow Medical has announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman chronic total occlusion (CTO) catheter. Reflow Medical has partnered with Century Medical, a medical device distributor based in Tokyo, to introduce the Wingman...
"Sac regression should be the new paradigm of success after EVAR ," concluded Dittmar Böckler (University of Heidelberg, Heidelberg, Germany) at the European Society for Vascular Surgery (ESVS) 2020 annual meeting (ESVS Month; 29 September–29 October, virtual).
New data from...
PQ Bypass has announced enrolment of the final subject in the company’s DETOUR II investigational device exemption (IDE) clinical trial. This milestone occurs only a month after the Detour system entered the US Food and Drug Administration (FDA)’s breakthrough...
A coalition organised by the CLI Global Society has announced its proposal to distinctly recognise "critical limb ischaemia" (CLI) and "chronic limb-threatening ischaemia" (CLTI) in the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) was approved by the...
A coalition organised by the CLI Global Society has announced its proposal to distinctly recognise "critical limb ischaemia" (CLI) and "chronic limb-threatening ischaemia" (CLTI) in the International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) was approved by the...
Alucent Biomedical recently announced the close of a US$35 million Series B financing round led by a large multinational strategic investor and joined by another new investor, Fresenius Medical Care Ventures. Alucent was founded by the Avera Research Institute,...
Mentice today signed a definitive agreement to acquire the New York-based medical technology company Vascular Simulations (VSI), a provider of replication solutions allowing endovascular procedures to be performed by doctors manipulating real medical devices within a physical 3D structure...
Results from the Fluorescence Imaging Assessment and Guidance (FLAAG) clinical trial, published recently in Advances in Wound Care, reveal that 82% of wounds in enrolled patients—which included diabetic foot ulcers, venous leg ulcers, pressure ulcers, and other chronic wounds—had...
Vascular surgeons are being encouraged to take consideration of a set of talking points about the risks and benefits of paclitaxel-equipped devices—which has developed by a multispecialty panel of medical societies—in discussions with their patients.
The document is the work...
The American Heart Association (AHA) recently announced the publication of a study identifying 14 new genes linked to an increased risk of abdominal aortic aneurysm (AAA).
Previous studies have detected 10 locations in the human genome associated with potential risks....
Teleflex has announced it has received 510(k) clearance from the US Food and Drug Administration to expand the indications for use of the Arrow EZ-IO intraosseous vascular access system. This device can be used when intravenous access is difficult...
Medtronic today announced the planned acquisition of Avenu Medical, a medical device company focused on the endovascular creation of arteriovenous (AV) fistulae for patients with end-stage renal disease (ESRD) undergoing dialysis. Terms of the transaction were not disclosed.
A press...
Royal Philips has announced the launch of the QuickClear mechanical thrombectomy system. The single-use system delivers an all-in-one aspiration pump and catheter to remove blood clots from the vessels of the peripheral arterial and venous systems and has received...
Scientists at the Tokyo University of Science (Tokyo, Japan) have developed a novel method to produce an alkaline hydrogel that can help improve wound healing. The method requires no specialised equipment and can be performed at room temperature to produce an alkaline hydrogel in five...
AOTI has announced an expansion of its multi-modality Topical Wound Oxygen (TWO2) therapy product family including the addition of a new larger extremity-chamber to the company's peripheral vascular disease (PVD) focused product line.
This has allowed for the application of TWO2 treatments for many more...
Silk Road Medical has announced that positive results from the ongoing TransCarotid Artery Revascularisation (TCAR) Surveillance Project, comparing TCAR with carotid endarterectomy (CEA), have been published in Annals of Surgery.
“These results continue to show low in-hospital stroke, death, and combined...
Midterm results from a study of the largest population of patients with no-option chronic limb-threatening ischaemia (CLTI) treated with percutaneous deep vein arterialisation (pDVA) using the LimFlow device show that, in this complex group of patients, this treatment method...
Surmodics has announced receipt of US Food and Drug Administration (FDA) 510(k) clearance for its Pounce thrombus retrieval system.
The company describes the Pounce system as a mechanical thrombectomy device intended for the nonsurgical removal of thrombi and emboli from...
To deliver clinical and cost benefits, leg ulcer care pathways should be revised to include early assessment and treatment of superficial venous reflux, researchers behind a recent Journal of the American Medical Association (JAMA) Surgery study suggest.
The investigators set...
Robert W “Bob” Gore, chair emeritus of the board of directors of W L Gore & Associates, passed away peacefully at home following a long illness on 17 September at the age of 83, the company he dedicated his...
Following approval this year by the US Food and Drug Administration (FDA) of the Treo abdominal aortic stent-graft system for the treatment of patients with abdominal aortic aneurysms (AAA), Terumo Aortic has announced the commercial launch of this endovascular...
The first patient has been recruited into a trial investigating the BeGraft peripheral plus stent graft system (Bentley InnoMed) as a dedicated bridging stent in branched endovascular aortic repair (BEVAR) for the treatment of complex aortic aneurysms. It is...
Gore has announced the US launch of the lower profile, large diameter Gore Viabahn endoprosthesis.
Gore previously received approval from the US Food and Drug Administration (FDA) for the enhanced Gore Viabahn endoprosthesis.
"With broad clinical indications for use and numerous...
Outcomes of the BIO4AMB trial demonstrated that ambulatory treatment with 4-French (4F) devices is a valid and safe option for endovascular treatment of lower extremity peripheral arterial disease (PAD), a Biotronik press release reports.
In addition, The 4F compatible products...
Shape Memory Medical has announced the initiation of AAA-SHAPE, the company’s prospective safety study of the Impede-FX embolisation plug devices when used for abdominal aortic aneurysm (AAA) sac filling during elective endovascular aneurysm repair (EVAR). The study’s first procedure...
Two devices for creating minimally invasive dialysis access—the Ellipsys vascular access system (Avenu Medical) and the WavelinQ 4F system (BD)—demonstrated high rates of technical success and low rates of complications, according to a new study.
In addition, both technologies enabled...
Smith and Nephew has teamed up with Avail Medsystems to provide remote, real-time collaboration services to its customers, directly in the operating room.
Streamlining procedures in both hospitals and ambulatory surgery centres (ASCs) is becoming increasingly important with operating room...
Panagiotis M Kitrou and Nicholas Inston discuss the impact of the COVID-19 pandemic on vascular access services. Despite the disruption caused, they are optimistic that the pandemic should be viewed as a catalyst for change. It is time to...
Concept Medical has announced the enrolment of the first patient in the FUTURE SFA (Randomised controlled trial of first sirolimus coated balloon versus standard balloon angioplasty in the Treatment of superficial femoral artery and popliteal artery disease) study.
The index...
Symptomatic peripheral arterial disease (PAD) patients undergoing recurrent lower extremity revascularisation have higher rates of ischaemic events, particularly acute limb ischaemia, than those patients who are undergoing their first peripheral revascularisation. This is the conclusion presented by Marc Bonaca...
Stefan Müller-Hülsbeck (Ev Luth Diakonissenanstalt zu Flensburg, Flensburg, Germany) presented attendees of the online meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE; 12–15 September, virtual) with an update from the IMPERIAL head-to-head randomised trial comparing the...
An ad hoc, two-year analysis of the EffPac study found no signal of increased risk of long-term mortality, nor any adverse events, within two years of drug-coated balloon (DCB) angioplasty using a Luminor-35 device (iVascular). This was the conclusion...
Against the backdrop of increasing end-stage renal disease (ESRD) prevalence in the USA, Bart Dolmatch (Portola Valley, USA) presented the 24-month results of the prospective, randomised controlled AVeNEW study at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE)...
“Please feel free to utilise this in your practice,” Michael Dake (University of Arizona Health Sciences, Tucson, USA) urged on the first day of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2020 Symposium (12–15 September, virtual). Speaking...
In the final session of the inaugural CX Aortic Vienna meeting, Maarit Venermo (Helsinki, Finland), and Roberto Chiesa (Milan, Italy) steered the audience through animated discussion on thoracic endografts and thoracoabdominal repair.
This session, and all other sessions from day...
Expert speakers gathered online on the last day of CX Aortic Vienna to discuss juxtarenal issues in the challenging abdominal aneurysm neck, covering topics including the use of endoanchors.
This session, and all other sessions from day four of...
The final day of CX Aortic Vienna opened with a second joint session designed and hosted by the Swiss Society for Vascular Surgery (SGG) and the Austrian Society of Vascular Surgery (ÖGG). Delivered in English, presentations reached a global...
On Friday, CX Aortic Vienna livestreamed two more sessions in its “Best of CX and all abstracts” series, underscoring key research in the aortic space.
These sessions, and all other sessions from day four of CX Aortic Vienna, are available...
From his early days in cardiac surgery through to his professorship in Milan, Italy, Roberto Chiesa talks to Vascular News about various aspects of his career so far. He stresses the importance of being skilled in both open and...
Use of a specifically designed stent graft to treat a fragile aorta was backed by three quarters of the CX Aortic Vienna audience, polled during a session on the timing of intervention in thoracic aortic dissection.
Stéphan Haulon (Paris, France)...
The third day of CX Aortic Vienna saw Italy’s vascular and endovascular expertise showcased on the global stage, in a live session hosted by the Italian Society of Vascular and Endovascular Surgery (Società Italiana di Chirurgia Vascolare ed Endovascolare;...
Polling at CX Aortic Vienna points to a high level of vigilance over radiation exposure during endovascular aneurysm repair (EVAR). This was among the messages to emerge from a discussion on the optimal use of aortic imaging for diagnostic...
Opening the session on iliac arteries and the five-branch technique for type I endoleaks, Christopher Neumayer (Vienna, Austria) argued that the superficial femoral vein should be used for reconstruction in septic aortic surgery.
“Aortic infections have a high incidence of...
CX Aortic Vienna (8–11 September, livestreamed) hosted the second session in its “Best of CX and all abstracts” series on Thursday, highlighting the breadth of research taking place in the aortic space.
Opening the session, Filipe Fernandes (Lisbon, Portugal), an...
Joseph Coselli (Houston, USA) and Rodney White (Torrance, USA) led the discussion on treatment options for the aortic arch zones 0,1,2,3 in a CX Aortic Vienna (8–11 September, virtual) session that covered a broad range of techniques.
This session, and...
The spotlight turned to the topic of thoracic aortic dissections—both type A and B using both endovascular and open approaches—in the final of CX Aortic Vienna's six Wednesday sessions. Polling revealed that 94% of viewers believe timing of intervention...
CX Aortic Vienna (8–11 September, virtual) hosted a “Best of CX and all abstracts” session on Wednesday, highlighting some of the more impactful and prominent work in the aortic space.
This session, and all other sessions from day one of...
During the CX Aortic Vienna sac size and endovascular aneurysm repair (EVAR) follow-up session, polling revealed that 94% of the audience agreed with the statement “The only thing that matters in post-EVAR surveillance is sac diameter”.
This result followed a...
Wednesday’s CX Aortic Vienna programme began with the inaugural joint session of the Austrian Society of Vascular Surgery (ÖGG) and the Swiss Society for Vascular Surgery (SGG). The programme, created by the two societies and delivered in English, piqued...
On 21 July 2020, Dr Victor M Bernhard, 93, died at his home in Port Charlotte, Florida, attended by his wife and members of his immediate family.
Dr Bernhard was born in 1927 and grew up in Milwaukee, Wisconsin, the...
In the ascending aorta session at CX Aortic Vienna, presentations focused on various treatment options, including frozen elephant trunk (FET) and endovascular intervention. The panellists emphasised the scarcity of data in this zone and called for data gathering. Simultaneously, the discussion highlighted...
The first session of CX Aortic Vienna (8–11 September, virtual) saw expert speakers discuss different approaches to abdominal aortic aneurysm repair—including open and endovascular techniques. Gustavo Oderich (Houston, USA) opened the session detailing an experimental ex vivo endovascular aneurysm...
In this supplement, sponsored by Philips:
Paul Gagne explains how intravascular ultrasound (IVUS) can be used to guide the treatment of chronic venous disease, discussing the various pathologies and patients in which the benefits of IVUS imaging are “irrefutable”
...
Biotronik today announced European market release of the Passeo-35 Xeo percutaneous transluminal angioplasty (PTA) balloon catheter. A company press release states that, compared to other available PTA balloons, the device offers physicians improved crossability, excellent trackability, and pushability in...
The Center for Medicare and Medicaid Services have released for comment its proposed CY 2021 updates to the Hospital Outpatient Prospective Payment System and Physician Fee Schedule. Below, verbatim, are several provisions the Alliance of Wound Care Stakeholders has...
The Wound Healing Foundation held their awards ceremony at the Symposium on Advanced Wound Care–Wound Healing Society (SAWC–WHS) virtual meeting (24–26 July 2020). Winners are as follows:
2020 WHF Thomas K Hunt Lecturer: Margaret A Liu
COVID-19: The Intersection of Vaccine...
According to a recent analysis, the decision to delay operative repair of abdominal aortic aneurysm (AAA) should consider both patient age and local COVID-19 prevalence in addition to aneurysm size. Furthermore, endovascular aneurysm repair (EVAR) should be considered when...
Amniox Medical, a TissueTech company involved in the research of the clinical application of human birth tissue-based products, recently announced that Yun Guan (Johns Hopkins University School of Medicine, Baltimore, USA) has been awarded a five-year R01 grant from...
A multidisciplinary limb preservation service under the leadership of vascular surgery in a level one trauma centre was associated with an immediate and rapid decline in the number of amputations performed for all indications, including trauma, acute limb ischaemia...
In this issue:
What to expect from the inaugural CX Aortic Vienna meeting, which will be livestreamed 8–11 September to an international, online audience (p. 1 and p. 10)
Collaborative efforts seek to understand COVID-19 impact on vascular patients...
In this issue:
What to expect from the inaugural CX Aortic Vienna meeting, which will be livestreamed 8–11 September to an international, online audience (p. 1 and p. 10)
Collaborative efforts seek to understand COVID-19 impact on vascular...
Boston Scientific announced that the US Centers for Medicare and Medicaid Services (CMS) granted a new technology add-on payment (NTAP) for the Eluvia drug-eluting vascular stent system as part of the 2021 inpatient prospective payment system (IPPS).
The NTAP...
According to a recent press release, MicroPort’s Minos ultra-low abdominal aortic aneurysm (AAA) stent graft and and Hercules low-profile thoracic aortic aneurysm (TAA) stent graft are now CE marked and available in Europe through Lombard Medical.
In addition, the first...
The Ellipsys vascular access system (Avenu Medical) reduces the time before patients with kidney failure can start lifesaving dialysis treatments, while requiring fewer secondary procedures, according to a new study led by interventional radiologist Jeffrey Hull (Richmond Vascular Center,...
Endologix has announced the first implant of its recently approved Alto endograft outside of the USA, completed by Andrew Holden and Andrew Hill of Auckland City Hospital, Auckland, New Zealand.
"With the 7mm infrarenal placement of its sealing ring, Alto...
CryoLife has announced the acquisition of Ascyrus Medical, developer of the Ascyrus Medical Dissection Stent (AMDS), an aortic arch remodelling device used for the treatment of acute Type A aortic dissections.
The addition of the AMDS to CryoLife's product...
PQ Bypass has announced that they received breakthrough device designation from the US Food and Drug Administration (FDA) for the Detour system. The Detour system is the world’s first fully-percutaneous femoral-popliteal bypass device intended to treat extremely long, complex...
NOTE: This supplement is only available to read in selected countries and geographies
In this supplement, sponsored by CryoLife:
Augusto D’Onofrio, Giorgia Cibin, and Michele Antonello outline the features and benefits of the JOTEC E-vita OPEN NEO and the NEXUS...
Patients with diabetes are at a higher risk of mortality when discharged from hospital, a recent study published in the Journal of Diabetes and its complications concludes. The authors, Teesta Mukherjee (Institute of Digital Healthcare, WMG, University of Warwick,...
Royal Philips has announced the next-generation of its Azurion image-guided therapy platform, designed to improve the quality and efficiency of interventional procedures. The Azurion platform has been used in over two million procedures worldwide since its introduction three years...
Veryan Medical recently announced the US launch and first commercial implant in the USA of the BioMimics 3D vascular stent system.
According to a press release, the BioMimics 3D self-expanding, nitinol stent features a highly-differentiated, helical centre-line design that has...
The results of a randomised controlled trial—the Shunt simulation study—show that a new patient-specific computation model accurately calculated postoperative access flow. As flow is related to maturation, the authors argue that this model may potentially improve arteriovenous fistula (AVF)...
The inaugural CX Aortic Vienna meeting will be livestreamed 8–11 September 2020 to an international, online audience, and will include registrant participation, interaction, and polling.
The programme will focus on all matters aortic—from the aortic valve to the iliac arteries....
In octogenarians with chronic limb-threatening ischaemia (CLTI), researchers found a one-year mortality rate of 32% after revascularisation, which was significantly higher than in non-octogenarians. Amputation rates were comparable between both age groups.
The authors—Lina F Wübbeke (Maastricht University Medical...
Concept Medical has announced the enrolment of the first patient in the FUTURE BTK (Randomised controlled trial of first sirolimus-coated balloon versus standard balloon angioplasty in the treatment of below-the-knee artery disease) trial. The index patient was successfully enrolled...
Royal Philips today announced that it has signed an agreement to acquire Intact Vascular. According to a press release, Intact Vascular will enhance Philips’ image-guided therapy portfolio, combining Philips’ interventional imaging platform and diagnostic and therapeutic devices with Intact...
The Alliance of Wound Care stakeholders recently submitted comments to the Centers for Medicare & Medicaid Services (CMS) to demand wound care is included in the US Department of Health and Human Services (HHS) and CMS grant waivers, as...
EO2 Concepts announced the release of an enhanced version of their full wound closure, at-home therapy system. The upgrade of the system consists of new and improved features for both the medical device, called the OxyGeni, and the OxySpur...
Patients with diabetic foot ulceration (DFUs) in Italy had more amputations during the height of the coronavirus pandemic—March to May 2020—than over the same time period in 2019, according to a newly published study.
The study, led by Paola Caruso...
Researchers claim to have developed cellulose membranes that eliminate wound infections early on, as they look to tackle the issues of increased antibiotic resistance.
If germs invade a wound, they can trigger a long-lasting infection that may fail to heal...
The reliable outcomes of Getinge’s Advanta V12 have been reinforced by a new systematic literature review. A group of physicians from around the world joined to compare published studies of covered balloon-expandable (CBE) stents for aortoiliac occlusive disease (AIOD)....
A recent systematic review showed that randomised trials comparing different types of peripheral endovascular arterial intervention have a high level of heterogeneity in their antithrombotic regimens. It also revealed an increasing trend for use of dual antiplatelet therapy post...
Amidst the continuing COVID-19 pandemic, concerns have mounted in the vascular community about the disruption to clinical routine. As vascular patients are particularly vulnerable to both COVID-19 and the effects of delayed surgical care, a need for collaboration, data,...
AngioDynamics has announced the enrolment of the first patient in the PATHFINDER I postmarket registry.
The PATHFINDER I registry is a pilot study to evaluate the safety and efficacy of the Auryon atherectomy system in the real-world treatment of de...
Just-published six-month results of the IN.PACT AV Access study show that drug-coated balloon (DCB) angioplasty is superior to standard angioplasty for the treatment of stenotic lesions in dysfunctional haemodialysis arteriovenous fistulas (AVFs). Furthermore, it was found to be non-inferior...
The US Food and Drug Administration (FDA) has granted Endospan an investigational device exemption (IDE) to start the TRIOMPHE study on the Nexus aortic arch stent graft system (Nexus).
Earlier this year, FDA granted Nexus designation as a breakthrough...
ID3 Medical Belgium has announced the first two enrolments in the SUPERSURG study to investigate the safety and efficacy of Abbott's Supera peripheral stent system versus surgical endarterectomy in treating patients with common femoral artery disease, with and without...
Vasorum and Veryan Medical have announced that from today Veryan Medical will support Vasorum in the commercialisation of the Celt arterial closure device (ACD) in the USA.
According to a press release, the Celt ACD has been used in...
In the EffPac trial, designed to compare a drug-coated and an uncoated balloon in the treatment of vascular occlusion in the femoropopliteal region, the drug-coated device proved to be superior. Additionally, the complete review of the study cohort two...
A recent study examining the effect of operative approach on outcomes in patients presenting with ruptured abdominal aortic aneurysm (rAAA) demonstrated clear short- and midterm survival benefits of endovascular repair over an open approach.
The authors—Linda J Wang (Massachusetts General...
A recent study, published online on 3 August in the European Journal of Vascular and Endovascular Surgery (EJVES), found that regional anaesthesia alone is reasonable for major lower extremity amputation (LEAMP) in high-risk patients, and may initiate a more...
When the 2019 journal impact factors were published earlier this summer, the European Journal of Vascular and Endovascular Surgery (EJVES) scored 5.328, an increase of 46% on the previous year. Here, for Vascular News, editor-in-chief Florian Dick (Kantonsspital St...
Endologix recently announced that it has received a CE mark for the Alto abdominal stent graft system.
“We are very excited to receive a CE mark for the Alto system, that has been achieved through a strong partnership and collaboration...
A new post-market study investigating the effectiveness of the Renzan peripheral stent system (Terumo) in patients with peripheral arterial disease (PAD) has been initiated.
The PRIZER (Prospective, multicentre post-market, single-arm study, to confirm the performance of the Renzan peripheral...
Surmodics recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its Sublime radial access 0.014 rapid exchange (RX) percutaneous transluminal angioplasty (PTA) dilatation catheter.
According to a press release, the Sublime radial access 0.014 RX...
Society for Vascular Surgery (SVS) president Ronald L Dalman (Stanford University, Stanford, USA) has pledged that the SVS and its flagship title the Journal of Vascular Surgery (JVS) will “accelerate changes already underway” in order to improve the culture surrounding...
Endologix has announced the first commercial implant and the US commercial release of its recently US Food and Drug Administration (FDA)-approved Alto endograft for the treatment of abdominal aortic aneurysms (AAA).
“Alto represents a differentiation from traditional endovascular aneurysm repair...
In this supplement, sponsored by Shockwave:
Frank Arko discusses his experience with intravascular lithotripsy (IVL) and considers its value in a resource-constrained healthcare environment
George Adams and Andrew Holden outline the benefits of fracturing intimal and medial calcium with...
Routine ultrasound-guided percutaneous transluminal angioplasty (PTA) is a feasible treatment for native arteriovenous fistula (AVF) dysfunction, according to a recent study by Antonio Granata (“Cannizzaro” Hospital, Catania, Italy). The findings were published online on 25 July in the Journal...
A team at the University of Washington in Seattle, USA, has received a funding award through the Patient-Centered Outcomes Research Institute (PCORI) Eugene Washington Engagement Awards programme to provide a patient-centric approach to those with—and at risk of—aortic dissection.
Led...
Hence Verhagen talks to Vascular News about his career in vascular surgery to date. He lauds the impact of the shift from open to endovascular techniques, but stresses that treatment results must get “a lot more durable” in the...
Preliminary evidence supports the use of a novel biophysical marker—the measurement of sub-epidermal moisture—to detect tissue damage early, allowing wound care specialists to identify pressure/shear-induced tissue damage and intervene “when the damage is still microscopic and reversible”. This is...
PolarityTE have announced positive results from a protocol-specified interim analysis of the first 50 patients enrolled in a multicentre randomised controlled trial evaluating treatment of diabetic foot ulcers with SkinTE plus standard of care (SOC) versus SOC alone.
SkinTE is...
Artio Medical today announced it has acquired Flow Forward Medical, a medical device company developing methods for establishing and maintaining vascular access sites.
This stock-for-stock merger transaction in which Flow Forward merged with and into Artio was approved by...
A dedicated protocol in the Bologna metropolitan vascular surgery unit in Italy allowed for the maintenance of regular elective vascular surgery activity during the emergency phase of the COVID-19 pandemic, with no contamination of patients of physicians and minimal...
This advertorial is sponsored by Bentley.
Maria Antonella Ruffino, a vascular interventional radiologist at Azienda Ospedaliera Universitaria Città della Salute e della Scienza in Turin, Italy, tells Vascular News about her team’s growing clinical experience with covered stents as a...
“The relative survival benefit of EVAR over open repair has increased over time,” conclude Rens RB Varkevisser (Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA) and colleagues in the July edition of the Journal of Vascular Surgery...
MedAlliance’s partner in Japan, MDK Medical, has enrolled the first patient in the clinical study of its novel sirolimus (SLR) drug-eluting balloon (DEB), Selution SLR, for the treatment of peripheral arterial disease (PAD). This follows the acceptance of a...
A new study shows significant benefits of the Ellipsys vascular access system (Avenu Medical) in easily and safely creating durable vascular access for end-stage renal disease (ESRD) patients who require haemodialysis.
According to an Avenu Medical press release, the system...
Walk Vascular and Veryan Medical have announced that Veryan Medical will support commercialisation of the Jeti peripheral thrombectomy system (Walk Vascular) in Germany.
Walk Vascular’s Jeti thrombectomy system employs an internal jet, located safely just inside its catheter mouth, capable...
Bluegrass Vascular Technologies has announced the publication of the results of its prospective, multicentre SAVE-US (Surfacer system to facilitate access in venous occlusions—United States) study in the Journal of Vascular Access.
This US Food and Drug Administration (FDA) approved...
World-first plasma-coated bandages with the power to attack infection and inflammation could revolutionise the treatment of chronic wounds such as pressure, diabetic, or vascular ulcers that will not heal on their own.
Developed by the University of South Australia, the...
In this issue:
Vascular education goes virtual in the COVID-19 era
Extensive coverage of CX 2020 LIVE and SVS ONLINE (p. 1 onwards)
PCR e-Course: Global SYMPLICITY Registry shows renal denervation lowered blood pressure in patients with hypertension out to three years (p....
In this issue:
Vascular education goes virtual in the COVID-19 era
Extensive coverage of CX 2020 LIVE and SVS ONLINE (p. 1 onwards)
PCR e-Course: Global SYMPLICITY Registry shows renal denervation lowered blood pressure in patients with hypertension out...
Responses to the COVID-19 pandemic practice, anxiety, coping and support survey for vascular surgeons, recently presented during SVS ONLINE (20 June–2 July), reveal higher anxiety and stress levels in vascular surgeons worried about the negative consequences of care delays...
Dynetic-35, the balloon-expandable cobalt chromium iliac stent system from Biotronik, is now commercially available in Europe. Indicated for the treatment of de novo or restenotic lesions in the iliac arteries, the product is approved for use in Europe and...
Reapplix has received Medicare reimbursement coding instructions from the Centers for Medicare and Medicaid Services (CMS) with a national average payment rate of US$1,622.74. The rate covers each patient visit to hospital outpatient departments to receive 3C Patch therapy...
The Indigo System Lightning 12 (Penumbra) is now commercially available in the USA, the company has revealed. In addition, Penumbra has announced the appointment of interventional radiologist Corey L Teigen (formerly Sanford Health, Fargo, USA) as chief scientific officer,...
Barts Health NHS Trust has performed a UK-first operation outside of trial setting that could reduce mortality and risks of infection in patients with dialysis.
Interventional radiologists at The Royal London Hospital (London, UK) have carried out the new minimally...
iVascular recently announced the launch of its Sergeant peripheral support catheter. Sergeant is a CE marked over-the-wire catheter, indicated for patients with peripheral arterial disease in small vessels or challenging anatomy during diagnostic and interventional procedures.
According to a press...
The third-generation Anaconda endograft (Terumo Aortic) provides “high technical success” and “satisfactory” five-year aneurysm exclusion and clinical success rates, a French multicentre prospective observational study (EPI-ANA-01) has found.
The investigators note that longer-term results with new generation endografts are “essential” due to a significant decrease in aneurysm-related survival...
Many changes, both possible and confirmed, are ahead for vascular surgery, according to the final SVS ONLINE session, “Assuring quality in vascular surgical care: The future of centre, programme and surgeon accreditation” held 2 July.
Society for Vascular Surgery (SVS)...
A new kit for imaging bacteria in wounds in a surgical and/or isolation setting is now available on the market. The i:X sterile surgical sleeve convenience kit, from MolecuLight, is made of a novel, optically-clear material that does not...
Doctor-prescribed and -supervised exercise therapy is going digital. The Society for Vascular Surgery (SVS) will begin piloting a ground-breaking app for Supervised Exercise Therapy (SET), for at-home use by patients with peripheral arterial disease (PAD).
The SET App was introduced...
Optimised cushioning provided by newly developed 3D printed insoles in diabetic footwear can significantly enhance their capacity to reduce plantar pressure, a new study concludes. This research was published in Gait and Posture, the official journal of the Gait...
Health care technology company Axxess has released a new comprehensive wound care management system that enables users to document and track wound care seamlessly.
The Axxess Wound Manager tracks wounds, wound care orders, and wound care in an easy-to-use, central...
A BIBA MedTech Insights survey (conducted May 2020) indicates a trend towards centres only performing emergency percutaneous peripheral procedures during the COVID-19 pandemic. However, this trend is not seen with stenting/angioplasty for critical limb-threatening ischaemia. With critical limb ischaemia,...
Endologix has announced that, after evaluating a variety of strategic options, it has initiated a voluntary Chapter 11 case and simultaneously filed a consensual plan of reorganisation supported by Deerfield Partners as its largest creditor.
According to a press...
Medtronic today announced the start of a prospective, observational, global, multicentre, real-world, post-market study to evaluate the safety and effectiveness of the Valiant Navion thoracic stent graft system in the treatment of thoracic aortic dissection. The first patient procedure...
A new therapy of hydration and oncotic pressure of plasma helped 100% of certain elderly peripheral artery disease (PAD) patients in terms of pain, ankle-brachial index (ABI), and walking time, endovascular pioneer Juan C Parodi told the SVS ONLINE...
A sirolimus-eluting balloon has been shown to be effective and safe for the treatment of vasculogenic erectile dysfunction (ED) in a first-in-man study presented at the PCR e-Course 2020 (25–27 June). Giuseppe Sangiorgi (Clinica San Gaudienzio, Novara, Italy) outlined...
Cook Medical recently announced that the Advance Serenity hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheter is now available to physicians in the USA. The catheter is manufactured by Surmodics and distributed by Cook Medical.
According to a press release, Advance...
Royal Philips recently announced the four-year results from the ILLUMENATE European randomised controlled trial (EU RCT). The Stellarex drug-coated balloon (DCB) cohort demonstrated similar all-cause mortality compared with the control arm through four years. This analysis included missing data...
LeMaitre Vascular recently announced that it has acquired the business and assets of Artegraft for US$90 million.
Under the terms of the deal, LeMaitre will continue to operate Artegraft’s manufacturing facility in North Brunswick, USA for at least three and...
Six-month clinical outcomes of the MERLION trial were presented as part of the VIVA Late-Breaking Clinical Trials Livesteam (25 June), by Tjun Tang (Singapore General Hospital, Singapore).
MERLION is a physician initiated, prospective, non-randomised multicentre trial investigating the safety and...
A BIBA MedTech Insights survey (conducted May 2020) indicates a trend towards centres only performing emergency percutaneous peripheral procedures during the COVID-19 pandemic. However, this trend is not seen with stenting/angioplasty for critical limb ischaemia. With critical limb ischaemia,...
A new survey, conducted in May 2020, shows that about 65% of physicians in Western Europe believe their centres could be performing their normal level of endovascular aneurysm repair (EVAR) procedures within three months of COVID-related restrictions being lifted....
During the last five weeks, CX 2020 LIVE has attracted over 6,000 registrants from more than 120 countries. The topic of the 10th and final session was Juxtarenal Aneurysm Consensus. Experts covered cutting-edge developments in the field and tips and tricks for...
Intact Vascular announced the positive one-year results from its Tack optimised balloon angioplasty (TOBA) II BTK clinical trial during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trial Livestream.
Co-principal investigator Patrick Geraghty, professor of Surgery and Radiology at the Washington...
In a real-world retrospective analysis, recently published in JACC: Cardiovascular Interventions, the long-term mortality rate was lower after drug-coated balloon (DCB) angioplasty than after plain balloon angioplasty of femoropopliteal lesions. First author Tanja Böhme, senior author Thomas Zeller (both Universitäts-Herzzentrum Freiburg-Bad Krozingen, Bad Krozingen, Germany), and colleagues note that...
The E Stanley Crawford Critical Issues Forum, which took place on the first day of SVS ONLINE, charted the course of vascular surgery going forward. This year, it was devised by newly installed president Ronald Dalman.
As is custom, the...
Medtronic has reported new data from the Global SYMPLICITY Registry (GSR), which showed that renal denervation (RDN) with the Medtronic Symplicity renal denervation system significantly reduced blood pressure (BP) in uncontrolled hypertension patients out to three years independent of...
In this issue of iWounds News:
How COVID-19 is changing wound care
Randomised trial of skin cell suspension confirms efficacy for healing venous ulcers
US podiatrists outline triage system and community care focus to combat COVID-19
William Ennis: Assessing the...
Vascular News spoke to the principal investigators of the BEST-CLI (Best endovascular versus best surgical therapy in critical limb ischaemia) trial—Alik Farber (Boston Medical Center, Boston, USA), Matthew Menard (Brigham and Women’s Hospital, Boston, USA), and Kenneth Rosenfield (Massachusetts...
The American College of Cardiology (ACC) and Society for Vascular Surgery (SVS) are collaborating on a single vascular registry, according to a press release, to harness the strengths of both organisations in improving care and outcomes of patients with...
