Daniel Clair (Vanderbilt University Medical Center, Nashville, USA) speaks to Vascular News at this year’s VEITHsymposium (14–18 November, New York, USA) on deep vein arterialisation with the LimFlow system (LimFlow). The technology aims to fill a treatment gap...
Inari Medical has announced the first patient enrolment in PEERLESS II. This prospective, global, multicentre randomised controlled trial (RCT) compares the outcomes of intermediate-risk acute pulmonary embolism (PE) patients treated with the FlowTriever system against those treated with traditional...
Penumbra today announced that the first patient has been enrolled in STORM-PE, a prospective, multicentre, randomised controlled trial (RCT) evaluating anticoagulation alone versus anticoagulation plus Lightning Flash for the treatment of pulmonary embolism (PE).
In partnership with PERT Consortium,...
Biotronik has announced the presentation of two-year results from the investigator-initiated BIOPACT randomised controlled trial (RCT) by principal investigator Koen Deloose (AZ Sint-Blasius Hospital, Dendermonde, Belgium) at the Paris Vascular Insights (PVI) 2023 congress (8–10 November, Paris, France). The...
Inari Medical has announced that it has completed its acquisition of chronic limb-threatening ischaemia (CLTI) treatment maker LimFlow.
The Irvine, California–based company earlier this month announced plans to acquire LimFlow for up to US$415 million. The deal came just weeks...
Lawrence Garcia (St Francis Hospital, New York, USA) speaks to Vascular News at VIVA 2023 (30 October–2 November, Las Vegas, USA) on lessons learned from a series of failed below-the-knee (BTK) trials that preceded the recent “first victory” of...
Vincent Rowe (University of California Los Angeles, Los Angeles, USA) speaks to Vascular News at VIVA 2023 (30 October–2 November, Las Vegas, USA) on the importance of patient-specific decisions for the management of vascular wounds.
He also considers how multidisciplinary...
Peter Schneider (University of California San Francisco, San Francisco, USA) recently presented 36-month data from Surmodics' TRANSCEND clinical trial at the VEITHsymposium 2023 (14–18 November, New York, USA).
The TRANSCEND trial is a prospective, multicentre, single-blind randomised controlled trial to...
Cordis has announced the completion of patient enrolment in the RADIANCY premarket clinical study. The prospective, multicentre, single-arm study is designed to evaluate the safety and efficacy of the S.M.A.R.T. Radianz vascular stent system when used with the Brite...
Medtronic has announced approval from the USA Food and Drug Administration (FDA) for the Symplicity Spyral renal denervation (RDN) system for the treatment of hypertension. The company has said that it will immediately begin commercialisation following the approval.
“Medtronic has...
This advertorial is sponsored by Cardionovum.
Cardionovum’s CE-marked Aperto drug-coated balloon (DCB) is, according to expert opinion and a growing evidence base, spearheading a revolution in the realm of vascular access maintenance for dialysis patients.
This high-pressure DCB has been specifically...
Xeltis has announced "highly encouraging" 12-month results from its first-in-human (FIH) aXess vascular conduit trial. The data were presented by Frans Moll (University Medical Center Utrecht, Utrecht, The Netherlands) at this year's VEITHsymposium (14–18 November, New York, USA).
At 12...
An ongoing UK National Institute for Health and Care Research (NIHR)-funded randomised controlled trial seeks to illuminate the value of an image fusion guidance technology for endovascular aortic repair.
In a presentation on the trial at this year’s VEITHsymposium (14–18...
Two-year data from the SWING trial, a first-in-human study of the safety and performance of the Sundance sirolimus drug-coated balloon (DCB; Surmodics), have been presented at this year's VEITHsymposium (14–18 November, New York, USA).
The SWING trial is a 35-patient...
New analyses from the VOYAGER PAD clinical trial in both high-risk and fragile patients and those with and without comorbid coronary artery diseases (CAD) were presented at the American Heart Association (AHA) 2023 Scientific Sessions (11–13 November, Philadelphia, USA).
The...
Vivasure Medical has enrolled the 100th patient in its PATCH clinical study, a multicentre, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal closure device system.
The US Food and Drug Administration (FDA) granted investigational device exemption...
Shape Memory Medical, developer of custom shape memory polymers for endovascular markets, announced that one-year data from the AAA-SHAPE safety trial will be presented during the 50th annual VEITHsymposium (14–18 November, New York City, USA) on Tuesday, November 14,...
A new study published in BJS Open has found that revascularisation treatment to restore blood flow to the legs of patients with severely blocked arteries is no more expensive than carrying out an amputation.
The peer-reviewed paper is the first to compare...
Cordis has announced that its board of directors has appointed Scott Drake as chief executive officer (CEO) effective immediately. Drake most recently held the position of executive chairman of the Cordis board of directors. He will succeed Shar Matin,...
Recor Medical has become the first company in the USA to have a device-based therapy approved for the treatment of hypertension, after it was announced that the US Food and Drug Administration (FDA) has approved the company’s Paradise ultrasound...
Patients undergoing computer-assisted vacuum thrombectomy with the Indigo Aspiration System (Penumbra) for pulmonary embolism (PE) showed 2.7% rates of both major adverse events (MAEs) and major bleeding at 48 hours post-procedure alongside “a significant reduction” in right ventricle/left ventricle...
One-year results from the PROMISE II US pivotal trial demonstrate the durability of outcomes of transcatheter arterialisation of the deep veins (TADV) using the LimFlow system (LimFlow) and that the procedure is safe and reproducible.
Daniel Clair (Vanderbilt University Medical...
Endologix has announced results from a pooled analysis of the DETOUR1 and DETOUR2 studies evaluating percutaneous transmural arterial bypass (PTAB) with the Detour system.
A press release details that PTAB with the Detour system offers a novel approach to treating...
InspireMD recently presented 30-day results from the C-GUARDIANS US investigational device exemption (IDE) clinical trial evaluating its CGuard embolic prevention stent (EPS) system for stroke prevention at VIVA 2023 (30 October–2 November, Las Vegas, USA). The presentation, which was...
Contego Medical has announced the presentation of late-breaking clinical results from the PERFORMANCE II carotid stent trial at VIVA 2023 (30 October–2 November, Las Vegas, USA). PERFORMANCE II is a prospective, multicentre study evaluating the safety and effectiveness of...
Nectero Medical today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the Nectero Endovascular Aneurysm Stabilisation Treatment (Nectero EAST) system to treat patients with infrarenal abdominal aortic aneurysms (AAAs), maximum diameter 3.5–5cm....
LimFlow announced today that it has entered into a definitive agreement to be acquired by Inari Medical.
A press release details that, under the terms of the agreement, LimFlow will receive US$250 million in cash at closing and be eligible...
Surmodics has announced the commercial launch of its most advanced hydrophilic medical device coating technology, the Preside hydrophilic coatings.
As per a company press release, Preside hydrophilic coatings complement Surmodics’ existing Serene hydrophilic coatings by providing customers with a unique,...
Endovascular Engineering (E2) has announced positive initial results from its ENGULF study, demonstrating successful outcomes among the first 15 patients evaluated in the trial using the Hēlo thrombectomy system for the treatment of acute sub-massive pulmonary embolism.
The ENGULF Study...
New research from the FLASH registry shines a light on the effectiveness of large-bore mechanical thrombectomy in managing high-risk pulmonary embolism. The study, titled "Mechanical thrombectomy for high-risk pulmonary embolism: Insights from the US cohort of the FLASH registry," provides valuable insights into this life-saving...
Results from a first-in-human, prospective, single-arm study of the Akura Medical thrombectomy system (Akura Medical) for pulmonary embolism (PE) were revealed this week at The VEINS 2023 (28–30 October, Las Vegas, USA).
Presenter Jay Mathews (Manatee Memorial Hospital, Bradenton, USA)...
The open-label phase of the DEXTERITY-AFP trial investigating the Bullfrog microinfusion device—which involves the perivenous injection of the anti-inflammatory drug dexamethasone to improve patency and post-thrombotic syndrome (PTS) six months after thrombus removal in symptomatic deep vein thrombosis (DVT)...
A secondary analysis of existing clinical trial data has indicated that new ischaemic brain lesions detected via diffusion-weighted magnetic resonance imaging (DW-MRI) following carotid artery revascularisation—either with carotid artery stenting (CAS) or carotid endarterectomy (CEA)—do not appear to have...
David Dexter (Sentara Vascular Specialists, Norfolk, USA) shared one-year data from the CLOUT registry this week at The VEINS 2023 (28–30 October, Las Vegas, USA).
Long-term, prospective outcome data after mechanical thrombectomy for deep vein thrombosis (DVT) are lacking. The...
Getinge has announced commercial availability of the iCast covered stent system in the USA for the treatment of iliac arterial occlusive disease. In March 2023, the iCast covered stent received premarket approval from the US Food and Drug Administration...
Vein360 has announced it received US Food and Drug Administration (FDA) 510(k) clearance for reprocessing the Philips Visions PV 0.035 digital intravascular ultrasound (IVUS) catheter in June of 2023 and the Visions PV 0.018 digital IVUS catheter in August...
In this issue:
Obituary: Roger M Greenhalgh 6th February 1941 – 6th October 2023
Forty five-year legacy of CX vascular education continues: The new CX Symposium co-chairs look ahead to CX 2024
In profile: Peter Schneider (San Francisco, USA)
Claire Dawkins (Newcastle,...
In this issue:
Obituary: Roger M Greenhalgh 6th February 1941 – 6th October 2023
Forty five-year legacy of CX vascular education continues: The new CX Symposium co-chairs look ahead to CX 2024
In profile: Peter Schneider (San Francisco, USA)
...
Rachel Bell (Newcastle, UK) shares her thoughts on a recent UK survey that highlights the prevalence of sexual misconduct within surgery and advises what should be done to address the issue.
Sexual harassment and misconduct in medicine is sadly too...
A survey of more than 1,400 individuals in the UK reveals that, in the past five years, nearly a third of female surgeons reported having been sexually assaulted by a colleague and over two-thirds reported having been the target...
Data from the REAL-PE study were presented this week at TCT 2023 (23–26 October, San Francisco, USA) demonstrating that patients treated for pulmonary embolism (PE) with the Ekos endovascular system (Boston Scientific) had lower rates of adverse events, including...
Thrombolex has announced never-before-reported major reductions in obstruction in all of the segmental pulmonary arteries (PA), based on independent core lab data analysis of 107 patients from 18 sites in the USA, with acute intermediate-risk pulmonary embolism (PE), using...
Results of the LIFE-BTK randomised controlled trial have just been presented at TCT 2023 (23–26 October, San Francisco, USA). The data show that, in patients with chronic limb-threatening ischaemia (CLTI) due to infrapopliteal artery disease, an everolimus-eluting resorbable scaffold...
Data from a patient-level meta-analysis—a factor in the US Food and Drug Administration’s (FDA) recent change of position on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD)—have been made public for the first time at TCT...
Robocath has today announced the results of its CARE clinical trial focusing on robotic carotid stenting—the first phase of a research programme launched in July 2021 by Robocath and Rennes University Hospital (Rennes, France), which, in the long term,...
Evident Vascular, a medical technology startup developing an intravascular ultrasound (IVUS) platform leveraging artificial intelligence to enable superior imaging and streamlined workflows, recently announced that it has launched with a US$35 million Series A financing from Vensana Capital.
“The impetus...
Cardio Flow recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow orbital atherectomy peripheral platform.
The company details in a press release that the FreedomFlow platform is designed with a modern mechanism...
Alcami has welcomed the recent announcement by Nectero Medical that it has received clearance from the US Food and Drug Administration (FDA) of their investigational new drug (IND) application to initiate a Phase II/III trial of the Nectero Endovascular...
New research examining the safety and efficacy of using radial access for peripheral artery interventions has found that radial access allows early ambulation and same-day discharge with no serious adverse events.
These are the conclusions of a study published in...
NOTE: This video is ONLY available to watch in selected countries and geographies
The EffPac trial was a prospective, multicentre, randomised controlled trial (RCT) that enrolled 171 patients of Rutherford category two to four with medium-length femoropopliteal lesions. Patients...
While sex disparities regarding the outcomes of carotid revascularisation have “long been a concern”, new prospective data published in the Journal of Vascular Surgery (JVS) indicate that no such disparity exists between male and female patients treated with transcarotid...
Discussions on the role of aritifical intelligence in the vascular field and emerging deep venous valve technologies caught readers' attention in September.
1. Humacyte announces positive top line results from Phase 2/3 trial of Human Acellular Vessel in treatment of...
Three newly appointed Charing Cross International Symposium (CX) co-chairs will ensure Roger Greenhalgh’s inspiring legacy of vascular education continues at CX 2024 with the 46th CX Symposium. Dittmar Böckler (Heidelberg, Germany), Andrew Holden (Auckland, New Zealand) and Erin Murphy...
Contego Medical has announced enrolment of the first patient in the prospective, multicentre PERFORMANCE III trial aimed at further evaluating the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) direct system—a carotid stent system designed for direct transcarotid...
Roger Malcolm Greenhalgh, the surgeon internationally renowned for his unparalleled contribution to vascular education, training and research, died peacefully on 6th October, aged 82. At the time of his death, he was emeritus Professor of Surgery at Imperial College...
Artivion has announced presentation of interim results from the Ascyrus medical dissection stent (AMDS) PERSEVERE clinical trial in a late-breaking science session at the 37th European Association for Cardio-Thoracic Surgery (EACTS) annual meeting (4–7 October, Vienna, Austria).
Fernando Fleischman (Keck...
An investigator-sponsored clinical study conducted at the Mayo Clinic in Rochester, Minnesota, of the investigational Human Acellular Vessel (HAV) in patients with chronic limb-threatening ischemia (CLTI) was presented at the Midwestern Vascular Surgical Society (MVSS) annual meeting in Minneapolis,...
MedAlliance has been acquired by Cordis for a 2022 investment of US$35 million and a 2023 upfront closing payment of US$200 million, together with regulatory achievement milestones of up to US$125 million and commercial milestones of up to US$775...
A vascular surgery team from the University of Southern California (USC) in Los Angeles demonstrated the feasibility of multidisciplinary direct revascularization of segmental arteries to prevent spinal cord ischemia (SCI) using novel endovascular or extra-anatomic bypass techniques in high-risk...
Laminate Medical Technologies has announced their flagship device, the VasQ External Vascular Support, has been cleared by the US Food and Drug Administration (FDA) for use to create arteriovenous fistulas (AVFs) for dialysis access. The device, designated by the...
Shockwave Medical has announced that Nick West has joined the company in the role of associate chief medical officer (CMO). He will report to current CMO Keith Dawkins, and will be based in Santa Clara (USA) with plans to...
Biotronik recently announced two-year-results from the BIOLUX P-III BENELUX all-comers registry, presented by principal investigator Frank Vermassen (UZ Ghent, Ghent, Belgium) at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress 2023 (9–13 September, Copenhagen, Denmark). The prospective,...
The pursuit of a cure for deep venous valvular reflux—long considered to be the “holy grail” of deep venous disease—is underway, with new technologies set to address a longstanding unmet clinical need across the globe.
Chronic venous disease affects nearly...
Can we trust artificial intelligence (AI)? Will AI replace physician judgement? Experts recently addressed these and other key questions amidst an expansion of AI technologies in the vascular space.
AI is “here to stay”. This is according to Randy Moore...
Nicolas J Mouawad (McLaren Health System, Bay City, USA) urges vascular surgeons to “get out of their comfort zone” and become more involved in pulmonary embolism (PE) care.
With over one million cases of deep vein thrombosis (DVT) and/or PE...
“With effective use of apron and ceiling and table shields, operator doses can be reduced to the equivalent of one to two days of natural background radiation,” investigators write in the conclusion of a recently published study.
Richard W...
Humacyte has announced positive top line results from its V005 Phase 2/3 trial of the Human Acellular Vessel (HAV) in vascular trauma repair.
A press release reports that the single-arm clinical trial was a success and showed that the...
The US Food and Drug Administration (FDA) today announced approval of LimFlow therapy—a novel and minimally invasive procedure designed to bypass blockages in arteries of the legs and restore blood flow for many thousands of people suffering from chronic...
The Society for Vascular Surgery’s Patient Safety Organization (SVS PSO) has launched a national smoking cessation initiative. It includes tools and resources to help physicians, surgeons and other healthcare professionals to help their patients kick the smoking habit....
FastWave Medical recently announced the swift closure of an oversubscribed multi-million dollar private financing. A press release states that this achievement, secured in just a few weeks, highlights the growing interest and confidence in FastWave's ability to execute its...
Endologix has announced that the US Centers for Medicare & Medicaid Services (CMS) recently granted a New Technology Add-on Payment (NTAP) for the Detour system, a US Food and Drug Administration (FDA)-designated Breakthrough Device, as part of its Fiscal...
The Society for Vascular Surgery (SVS), American Venous Forum (AVF), and American Vein and Lymphatic Society (AVLS) have released the second and final part of new guidelines for the management of varicose veins of the lower extremities. The recommendations,...
Shape Memory Medical recently announced that the US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) for the company to begin a prospective, multicentre, randomised, open-label trial to determine safety and effectiveness of the Impede-FX RapidFill...
David Bosanquet (South East Wales Vascular Network, Cardiff, UK) is chief investigator of a new randomised trial—PLACEMENT—which addresses the topic of pain control around the time of a major amputation. Here, he speaks to Vascular News about the importance...
This advertorial, sponsored by Gore, is only available in selected countries and geographies.
In conversation with CX Vascular, Dennis Gable (The Heart Hospital Baylor Plano, Plano, USA) and Ross Milner (University of Chicago, Chicago, USA) outline how long-term data...
“The median thrombus age of DVT patients treated in our centre is 14 days – says Dr Andrew Wigham from Oxford University Hospitals. – We know that traditional treatment options such as thrombolytics and other thrombectomy devices are less...
In this issue:
Paclitaxel-coated devices: US FDA removes red flag after review finds data do not support mortality risk
“A hugely exciting time”: Experts focus in on artificial intelligence in the vascular field
In profile: Jürgen Falkensammer (Vienna, Austria)
Journal...
In this issue:
Paclitaxel-coated devices: US FDA removes red flag after review finds data do not support mortality risk
"A hugely exciting time": Experts focus in on artificial intelligence in the vascular field
In profile: Jürgen Falkensammer (Vienna, Austria)
...
The first US patient has been treated as part of the SOCRATES trial (Short neck AAA randomised trial—ESAR and FEVAR), which compares the safety and performance of endosuture aneurysm repair (ESAR) with fenestrated endovascular aneurysm repair (FEVAR) for the...
NOTE: This video is ONLY available to watch in selected countries and geographies
The benefits of Shockwave Medical’s new Shockwave L6 Peripheral Intravascular Lithotripsy (IVL) catheter—designed for use in large, calcified vessels (available in 8-12 mm diameter sizes), —were highlighted...
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new approved bodies to increase the country’s capacity to certify medical devices.
TÜV SÜD, Intertek, and TÜV Rheinland UK join the four current UK Approved Bodies, almost doubling...
“A truly novel and potentially groundbreaking treatment strategy for patients with small to mid-sized infrarenal abdominal aortic aneurysms,” is how Michael R. Jaff (Boston, USA) describes the Nectero Endovascular Aortic Stabilization Treatment (Nectero EAST®) System from Nectero Medical in...
This advertorial is sponsored by BD.
There has been major progress in the treatment of peripheral arterial disease (PAD) globally in the last few years, “but there are still issues that need to be addressed”, Marianne Brodmann (Medical University of...
This advertorial is sponsored by Boston Scientific.
Data on hundreds of thousands of patients who have received lower limb endovascular treatment provide confidence in paclitaxel safety. This central message from a Boston Scientific symposium at the recent Leipzig Interventional Course...
The Society for Cardiovascular Angiography & Interventions (SCAI) has welcomed the review of scientific data related to the premarket approval applications for two renal denervation systems, describing this as a “step forward to advancing access to additional therapies for...
The US Food and Drug Administration (FDA) Circulatory Systems Devices Panel met yesterday (23 August) to review evidence of the safety and efficacy of Medtronic’s Symplicity Spyral renal denervation system, with committee members split on the motion that the...
Nectero Medical today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the Nectero Endovascular Aneurysm Stabilisation Treatment (Nectero EAST) system to treat patients with infrarenal abdominal aortic aneurysms (AAAs) of maximum diameter 3.5–5cm....
Aquedeon Medical has announced its receipt of US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to conduct a staged pivotal clinical trial for the Duett vascular graft system in the USA. The study will be initiated...
The US Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee yesterday (22 August) voted that there is sufficient data to support the use of the Paradise ultrasound renal denervation system (Recor Medical)...
Cydar Medical has announced the successful treatment of the first patient in a strategic collaboration with Medtronic. The collaboration, which spans 40 sites across the USA, UK and Europe, involves the integration of the company’s Cydar Maps software with...
NOTE: This video is ONLY available to watch in selected countries and geographies
Experts gathered at the Society for Vascular Surgery’s 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland (June 14–17) to discuss the latest innovation from Shockwave...
Clinical outcomes of Humacyte's investigational Human Acellular Vessel (HAV) were presented at the recent Military Health System Research Symposium (14–17 August, Kissimmee, USA), following a year-long humanitarian program in Ukraine. The bioengineered, implantable human tissue-based device was provided to...
The Society for Cardiovascular Angiography & Interventions (SCAI) has released a position statement on renal denervation, in which it emphasises the importance on patient selection, optimal techniques, competence, training, and institutional recommendations in the use of the technique as...
A new study in the Journal of Vascular Surgery (JVS) finds that a patient’s postcode is a crucial indicator for advanced stages of an abdominal aortic aneurysm (AAA) at the time of endovascular aneurysm repair (EVAR) with a higher...
MedAlliance has announced completion of patient enrolment in the SAVE clinical trial with the Selution Sustained Limus Release (SLR) 018 drug-eluting balloon (DEB) for the treatment of failed arteriovenous fistulas (AVFs) in renal dialysis patients. Selution SLR is a...
July's top 10 highlights the US Food and Drug Administration's long-awaited update on paclitaxel-coated devices to treat peripheral arterial disease, an interview with Rachel Bell (Newcastle, UK), and some key industry updates.
1. FDA removes red flag for paclitaxel-coated devices...
“PERT care is the coalition of the willing,” quipped Dennis Gable, a vascular surgeon at Texas Vascular Associates in Plano, USA. He was referring to team-based care for pulmonary embolism (PE) patients and how, unlike acute stroke intervention and...
Merit Medical has announced that is has completed enrolment in its WRAPSODY arteriovenous access efficacy (WAVE) pivotal study. Merit’s WAVE study is a prospective, randomised, controlled, multicentre study comparing the Merit WRAPSODY cell-impermeable endoprosthesis (CIE) to percutaneous transluminal angioplasty...
Alucent Biomedical has announced that the US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) for a US clinical study of AlucentNVS, a unique light-activated, drug-coated balloon catheter technology.
AlucentNVS combines an intravascular device with a photochemical...
Pathfinder Medical has been awarded a Smart grant for a £1.1 million (US$1.4 million) project by Innovate UK, the UK's innovation agency. A press release details that the grant will support Pathfinder’s novel project to develop a minimally invasive...
The characterisation of aortic tissue by means of three key biomechanics-based biomarkers bundled into a compound Regional Areas of Weakness (RAW) Map showed “very good performance” as part of an artificial intelligence (AI)-based prediction of faster than average growth...
A specialist in complex open aortic surgery, Rachel Bell speaks to Vascular News about her career so far. Raised in Yorkshire, UK, she moved to London for medical school before recently making the move back to the north of...
RapidAI today announced US$75 million in Series C funding led by Vista Credit Partners, a subsidiary of Vista Equity Partners and strategic financing partner focused on the enterprise software, data and technology markets.
A press release details that the funding aims to...
Humacyte today announced completion of enrolment in its Phase II/III vascular trauma trial (V005) that is expected to support a Biologics License Application (BLA) filing for the company's Human Acellular Vessel (HAV) in vascular trauma repair.
A press release details...
The Society for Vascular Surgery (SVS) Foundation has announced the appointment of Bernadette Aulivola and Vikram Kashyap to its board of directors. Both will serve two-year terms and, with the board's collective knowledge and experience, will further bolster the...
Medical device company Access Vascular has announced the publication of a peer-reviewed study of its HydroPICC peripherally inserted central catheter (PICC) in the Journal of Materials Science: Materials in Medicine. The retrospective study found that HydroPICC “significantly reduced” clot formation...
Nectero Medical today announced that the US Food and Drug Administration (FDA) has granted investigational new drug (IND) clearance for the company to initiate a prospective, multicentre, randomised clinical trial (the stAAAble study) to evaluate the safety and efficacy...
Endologix has shared in a press release that the first patients underwent percutaneous transmural arterial bypass (PTAB) using the Detour system since US Food and Drug Administration (FDA) approval of the system was granted. This marks the official start...
In an official Society response, SVS president Joseph Mills tackles recent coverage in the mainstream media of inappropriateness in vascular care.
There have been several recently published articles by respected news media outlets highlighting the deeply concerning issue of the...
The president of the Society for Cardiovascular Angiography & Interventions (SCAI), George Dangas (Icahn School of Medicine at Mount Sinai, New York, USA), has welcomed the US Food and Drug Administration (FDA) decision to remove restrictions on the use...
In June 2023, the Cardiovascular Interventional Radiological Society of Europe (CIRSE) published an editorial in Cardiovascular Interventional Radiology (CVIR). Written on behalf of CIRSE’s Endovascular Subcommittee, the authors “advocate that the benefits of paclitaxel-coated device used in the femoropopliteal...
“There is an increasing awareness that we need to get aneurysm sacs to regress after endovascular aneurysm repair ,” Andrew Holden (Auckland, New Zealand) stated during a recent discussion with Michel Reijnen (Arnhem, The Netherlands) on potential solutions in...
Highlights from this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2023; 14–17 June, National Harbor, USA) feature prominently in June's top 10.
1. “Sonolysis is back” after safely reducing endarterectomy stroke risk in randomised trial
Positive results from a clinical...
At this year’s Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany), Sabine Steiner (Leipzig, Germany) shared first results from the BEST superficial femoral artery (SFA) pilot study—a prospective, multicentre randomised trial comparing the efficacy and safety of a...
Biotronik has announced one-year subgroup results from the investigator-initiated BIOPACT randomised controlled trial (RCT), which were presented by principal investigator Koen Deloose (AZ Sint-Blasius, Dendermonde, Belgium) at this year’s Leipzig Interventional Course (LINC 2023, 6–9 June, Leipzig, Germany).
The randomised...
In an interview with Venous News at this year’s Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany), Raghu Kolluri (Columbus, USA) outlines the “vast list” of options that are now available for the treatment of patients who require...
The release of a letter from the US Food and Drug Administration (FDA) concerning the use of paclitaxel-coated devices for the peripheral arterial disease (PAD) marks an important chapter in a long-running story.
December 2018
Meta-analysis finds a higher risk of...
Following yesterday's news that the US Food and Drug Administration (FDA) has changed its stance on the use of paclitaxel-coated devices to treat peripheral arterial disease (PAD), Boston Scientific has announced its position on the update. The company's full...
Cagent Vascular has announced the results of its below-the-knee (BTK) RECOIL study. This core lab-adjudicated Recoil analysis— the first of its kind, according to the company— evaluated vessel recoil in lesions treated with Serranator versus plain balloon angioplasty.
The study...
In a letter to healthcare providers dated 11 July 2023, the US Food and Drug Administration (FDA) communicates that the risk of mortality associated with paclitaxel-coated devices to treat peripheral arterial disease (PAD) is no longer supported based on...
Shape Memory Medical has announced that it has entered into a sublicense agreement with "a global medtech market leader" in a press release. Under the agreement, Shape Memory Medical will sublicense its proprietary shape memory polymer technology for a...
Why is clot removal crucial for patients suffering from DVT? What are the major benefits of a lytic-free thrombectomy? Watch Michael Lichtenberg (Arnsberg, Germany) present the outcomes of the Arnsberg ClotTriever Study which confirms the safety and efficacy of...
Terumo Aortic have today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has granted approval of the Thoraflex Hybrid frozen elephant trunk (FET) device for commercial sale in Japan for the treatment of patients with complex...
As announced at the Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2023; 14–17 June, National Harbor, USA), the Advance Serenity hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheter product line is now available with even more options. Interventionists...
The US Food and Drug Administration (FDA) has granted approval for Cook Medical to initiate an investigational device exemption (IDE) study on the Zenith fenestrated+ endovascular graft (ZFEN+).
The clinical study will assess the safety and effectiveness of the ZFEN+...
A new study from Keck Medicine at the University of Southern California (USC; Los Angeles, USA) has uncovered “significant racial disparities” in the diagnosis, treatment and outcomes of peripheral artery disease (PAD) among Black and white patients in the USA.
“We discovered that Black...
“It is time to question whether patients with end-stage below-the-knee peripheral arterial disease should not be treated primarily with deep vein arterialisation,” Arne Schwindt (Münster, Germany) avers in an interview with Vascular News.
Schwindt was speaking at this year’s Leipzig...
A temporary mechanical support with antiproliferative properties might combine two particular treatment qualities to fill a gap in the treatment armamentarium for peripheral arterial disease, both above and below the knee. Ramon Varcoe (Sydney, Australia) moderates a panel with...
Surmodics has announced the receipt of US Food and Drug Administration (FDA) approval for the SurVeil drug-coated balloon (DCB).
A company press release notes that the SurVeil DCB may now be marketed and sold in the USA to physicians for...
The local delivery of a glucose-derived compound in small- and medium-sized abdominal aortic aneurysms (AAAs) has been deemed safe, with “promising” early efficacy data indicating its potential in stabilising or slowing AAA sac growth. According to Stephen Cheng (University...
The findings of a recent study on reinterventions and sac dynamics after fenestrated endovascular aneurysm repair (FEVAR) with a physician-modified endograft (PMEG) for index aneurysm repair and following prior EVAR led researchers to conclude that “vigilant” surveillance and a...
Endospan has announced the initial experience with its custom-made Nexus Duo aortic arch stent graft system. Theodosios Bisdas (Athens Medical Centre, Athens, Greece) presented the multicentre European experience of the first ten patients treated with Nexus Duo at this...
The principal investigators behind the BEST-CLI trial struck a conciliatory tone during the inaugural Frank J Veith Distinguished Lecture at this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2023; 14–17 June, National Harbor, USA) in which...
“The endothelial cell is the superhero of the vascular system,” Kathryn L Howe (University of Toronto, Toronto, Canada) argued during an invited research presentation at this year’s Society for Vascular Surgery (SVS) Vascular Annual Meeting (VAM 2023; 14–17 June,...
Endologix has announced the 24-month results of the DETOUR2 study, presented at VAM 2023 (14–17 June, National Harbor, USA), the annual meeting of the Society for Vascular Surgery (SVS), by one of the study’s principal investigators, Sean Lyden (Cleveland...
Long-term overall survival (OS) and amputation-free survival (AFS) are outcomes that rebound in claudicants who quit smoking prior to elective surgery—and they mirror those of never smokers. But patients who do not kick the habit have significantly worse outcomes,...
NOTE: This video is ONLY available to watch in selected countries and geographies
The combined use of a drug-eluting device and a vascular scaffold “seems to be, in the longer run, the perfect solution for complex lesion treatment”. This...
Gore announced today the initiation of the Gore VBX FORWARD clinical study to compare the VBX stent graft to bare metal stenting for patients with complex iliac occlusive disease.
This prospective, multicentre, randomised controlled trial will include up to 40...
Surmodics announced in a press release that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (low profile) thrombectomy system.
Introduced in 2021, the Pounce thrombectomy system is intended for the non-surgical removal...
Terumo Aortic announced in a press release the launch of the company’s global post-approval study (PAS) known as EXTEND for Thoraflex Hybrid, the only frozen elephant trunk (FET) device approved by the US Food and Drug Administration (FDA) for...
Eric Secemsky (Boston, USA) and Edward Choke (Singapore) discuss the role of sirolimus-coated balloons in the treatment of peripheral arterial disease (PAD), particularly below the knee, at the Charing Cross (CX) Symposium (25–27 April, London, UK).
With high amputation and...
Sharing first-time data from the SOCRATES (ShOrt neCK AAA RAndomized Trial) design, Giovanni Torsello (St Franziskus Hospital, Münster, Germany) expanded on the intentions of the prospective, global, multicentre, randomised trial which he stated is the “first comparative” study to...
Endologix has announced in a press release that the US Food and Drug Administration (FDA) has granted approval for the Detour system to treat patients with complex peripheral arterial disease (PAD).
Patients with long blockages of the superficial femoral artery...
The Connect The World Session: Japan at this year’s Leipzig Interventional Course (LINC 2023, 6–9 June, Leipzig, Germany)—in collaboration with the Japanese Endovascular Treatment Conference (JET)—sparked discussion surrounding the latest data in femoropopliteal interventions. Giving platform to multiple...
Delivering first-release data, Scott O Trerotola (University of Pennsylvania, Philadelphia, USA) conveyed the “consistent results” in a real-world environment for the Lutonix arteriovenous (AV) post-approval study (PAS) for drug-coated balloon (DCB)-AV on the afternoon of the second day at...
Bentley announced at this year's Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany) that it has reached an important milestone: having sold the 300,000th BeGraft. This milestone was celebrated at the Bentley booth at LINC.
After launching the first...
Gore has announced that the first US patient has been enrolled in a prospective, non-randomised, multicentre, single-arm study with five-year follow-up to evaluate the investigational Gore Viafort vascular stent for the treatment of symptomatic iliofemoral venous obstruction.
The first US...
Following his first-to-podium presentation on statin treatment after aortic repair at the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK), Kevin Mani (Uppsala, Sweden) joined Janet Powell (London, UK) at the CX Vascular Live studio to discuss...
“I see a future where this technology may be used to treat people early and avoid the devastating long term consequences of venous insufficiency” Ramon Varcoe (Sydney, Australia) opined in a CX Vascular Live discussion with Erin Murphy (Charlotte,...
The US Food and Drug Administration (FDA) has released draft guidance with updated recommendations for good clinical practices (GCPs) aimed at modernising the design and conduct of clinical trials.
In a statement, the regulator said that the updates are intended...
Konstantinos Spanos (Larissa, Greece) recently shared new meta-analysis data from comparative studies evaluating balloon-expandable versus self-expandable stent grafts for branched endovascular aneurysm repair (BEVAR). Following his first-to-podium presentation at the 2023 Charing 2023 Charing Cross (CX) International Symposium (25–27...
Presenting first-time data from large multicentre European studies at this year's Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany), Arne Schwindt (St Franziskus Hospital Münster, Münster, Germany) and Ralf Langhoff (Sankt Gertrauden Hospital, Berlin, Germany) delivered results that...
While the exact location of atherosclerotic plaque ruptures—a common cause of myocardial infarction (MI) and stroke—has previously been unknown, researchers at Lund University (Lund, Sweden) have now managed to successfully map this phenomenon. In addition, the team has identified...
Biotronik today announced the limited release of its Oscar (One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter and start of promotional activities at this year's Leipzig Interventional Course (LINC 2023; 6–9 June, Leipzig, Germany).
As indicated per Instructions for...
Positive results from a clinical trial involving a novel therapeutic procedure known as sonolysis—deployed during a carotid endarterectomy (CEA)—were presented at the recent European Stroke Organisation Conference (ESOC; 24–26 May, Munich, Germany).
“The randomised clinical trial confirmed the results of...
Medtronic has announced that Ken Washington has been appointed chief technology and innovation officer.
Washington joins Medtronic from Amazon where he served as vice president and general manager of consumer robotics, and will lead technology development across industries including robotics,...
Penumbra has announced the US Food and Drug Administration (FDA) clearance and launch of Lightning Bolt 7, which the company claims is the most advanced and powerful arterial thrombectomy system on the market.
Lightning Bolt 7 introduces a new method...
NOTE: This video is ONLY available to watch in selected countries and geographies
Could drug-coated balloons (DCBs) be “the perfect device” for the treatment of patients with neointimal hyperplasia? Yes, opines Matteo Tozzi (University of Insubria, Varese, Italy) at...
This advertorial is sponsored by Shockwave Medical.
Mazin Foteh, MD, contrasts the benefits of Shockwave Medical’s new Shockwave L6 Peripheral Intravascular Lithotripsy Catheter alongside those of its sister device, the Shockwave M5+ Peripheral Intravascular Lithotripsy Catheter.
The Shockwave L6 device is...
A recent study has concluded that the “novel” technique of serration angioplasty with the Serranator balloon (Cagent Vascular) for the treatment of chronic limb-threatening ischaemia (CLTI) in the pedal arteries is “safe and effective”. Following his presentation of this...
This advertorial is sponsored by Inari Medical
“We need to eliminate symptoms as fast as possible—it is not OK just to make things a little better,” says Rick de Graaf (Clinical Centre of Friedrichshafen, Friedrichshafen, Germany), setting out why intervention...
Shape Memory Medical has announced the publication of results from the company’s prospective, open-label, single-arm, safety study of the Impede embolisation plug in peripheral vascular embolisation. The study was published this month in the peer-reviewed journal, Vascular, ahead of...
Twelve-month results from the SELUTION SFA trial have been presented for the first time at the Japan Endovascular Treatment (JET) Conference (26–28 May, Tokyo, Japan). The objective of this study was to assess the safety and efficacy of the...
Thirona recently announced its new artificial intelligence (AI)-based algorithm for pulmonary artery-vein phenotyping, LungQ AVX. The results from multiple validation studies were presented at the American Thoracic Society (ATS) 2023 International Conference (19-24 May, Washington, DC, USA).
A press release...
Cora Therapeutics has announced the presentation of the results of a clinical trial at the Canadian Association of Interventional Radiologists (CAIR) annual meeting (25–27 May, Quebec City, Canada), assessing the efficacy of its proprietary antioxidant complex in safeguarding DNA...
On 24 May, the US Food and Drug Administration (FDA) granted an investigational device exemption (IDE) approval for Concept Medical's MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus-coated balloon (SCB) for treatment of the superficial femoral artery (SFA).
This marks the fourth...
Interim results from the ECST-2 randomised controlled trial (RCT) have shown no evidence that carotid stenosis patients with a low-to-intermediate stroke risk, treated with optimised medical therapy, will benefit from additional carotid revascularisation via carotid endarterectomy (CEA) or carotid...
Speaking on the FLAME, FLASH and PEERLESS trials that each collected data on the FlowTriever (Inari Medical) device for the treatment of pulmonary embolism (PE), Ripal Gandhi (Miami Cardiac & Vascular Institute & Miami Cancer Institute, Miami, USA) elaborated...
A new study using data from millions of patients hospitalised across the USA has determined whether population density and associated urban versus suburban versus rural environments predispose patients with peripheral vascular disease for chronic poor blood flow in their...
This advertorial is sponsored by Cardionovum®.
In 2023, there are a number of different options available for treating the vascular access complications of thrombosis and stenosis, Matteo Tozzi (University of Insubria, Varese, Italy) tells Vascular News. He highlights that perhaps...
Data from a cohort of one million patients with chronic limb-threatening ischaemia (CLTI) were recently presented as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions (18–20 May, Phoenix, USA). Using data from Medicare,...
Presenting “remarkable results” from the JETi registry—a prospective, multicenter, observational study which collected real-world data on the safety, performance and clinical benefits of the JETi peripheral thrombectomy system—speaker Mahmood K. Razavi (Children’s Health of Orange County, Orange, USA) relayed...
Steven Abramowitz (Washington DC, USA) explains the significance of the CLOUT registry—the only registry capturing data on mechanical thrombectomy in deep venous thrombosis (DVT). CLOUT confirms excellent safety results and effectiveness of the ClotTriever system in real-world DVT patients....
Artificial intelligence (AI) is “here to stay”. This was the closing statement from Randy Moore (Calgary, Canada), vascular surgeon and chief medical officer (CMO) of ViTAA Medical Solutions, during a recent CX Vascular Live roundtable discussion. Moore was joined...
Endologix recently announced the completion of the 150th case in the JAGUAR study.
This randomised controlled trial is evaluating Endologix’s Alto abdominal stent graft system, comparing its effectiveness to other commercially available endovascular aneurysm repair (EVAR) devices in the...
Six-month outcomes from FLASH registry have shown that patients with pulmonary embolism who were treated with mechanical thrombectomy showed significant improvement in symptoms, quality of life and cardiac functions.
The findings were presented as late-breaking clinical research at the Society...
This advertorial, sponsored by Inari Medical, is only available in selected countries and geographies.
During a recent webinar hosted by Inari Medical, a multidisciplinary group of physicians focused in on how to select eligible patients for the endovascular treatment of...
A new analysis of chronic limb-threatening ischaemia (CLTI) treatment outcomes was presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions (18–20 May, Phoenix, USA), a press release reports.
Following the initial...
Both open and endovascular surgical approaches are likely to produce improved outcomes compared to ligation in the treatment of ruptured extracranial carotid artery aneurysms. This was the salient point delivered by Maarit Venermo (Helsinki University Hospital, Helsinki, Finland) at the...
Bentley has announced the US launch of its BeBack crossing catheter, which is designed for the treatment of heavily calcified lesions. This is the company's first product to be launched in the USA.
A press release notes that, after the...
In this issue:
Extensive coverage of CX 2023, including a full report of the BASIL-2 randomised controlled trial results
New guidelines: Chris Twine (Bristol, UK) and Stavros Kakkos (Patras, Greece) highlight key takeaways from soon-to-be-published recommendations on antithrombotic therapy for...
In this issue:
Extensive coverage of CX 2023, including a full report of the BASIL-2 randomised controlled trial results
New guidelines: Chris Twine (Bristol, UK) and Stavros Kakkos (Patras, Greece) highlight key takeaways from soon-to-be-published recommendations on antithrombotic therapy...
A recent proposal has called for “whole-person, multidisciplinary interventions” after an interrogation of the interplay between lower extremity peripheral arterial disease (PAD) and mental health impacts. Published in the Journal of The American College of Cardiology, researchers have put...
For the treatment of juxtarenal aortic aneurysms, reinterventions after physician-modified endovascular grafts (PMEGs) are non-detrimental to long-term survival. This is one of the main findings of a recently published study by Ayumi Tachida (University of Washington School of Medicine,...
With proper patient selection, short-term outcomes of thoracic endovascular aortic repair (TEVAR) in acute uncomplicated acute type B aortic dissection (uTBAD) are similar irrespective of the timing of treatment after dissection. This is according to a study recently published...
A nationwide cohort study of over 9,000 patients shows that the “controversial” practice of arteriotomy closure for carotid endarterectomy (CEA) is associated with an increased risk of ipsilateral stroke and “should be avoided”. Instead, authors Magnus Jonsson (Karolinska University...
The 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK) saw a first-to-podium presentation by Andrew Holden (Auckland City Hospital, Auckland, New Zealand) in which he presented new data from the IN.PACT AV Access trial of the IN.PACT...
April's top 10 sees a product announcement from Terumo Aortic take the top spot, with highlights from the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK) also proving popular among readers.
1. Terumo Aortic announces first implant of...
Judges of the CX 2023 Dragon’s Den-style contest — the finale of the Day 3 CX Innovation Showcase programme — described the field of entrants to this year’s edition of the competition as the strongest line-up in its history.
The...
Representatives from multiple specialties highlight a pressing need to drive up the quality of research and care for patients who require the “life-changing” intervention that is an amputation of the leg.
The UK government’s National Institute for Health and Care...
Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted approval of the RelayPro thoracic stent graft device for the treatment of dissection and transection in the USA.
A Terumo Aortic press release notes that RelayPro...
Xeltis has presented “highly-encouraging” six-month data from its first-in-human (FIH) aXess vascular graft trial at the 13th Congress of the Vascular Access Society (VAS; 27–29 April, Porto, Portugal).
A press release outlines that six-month data from the FIH trial found...
The first US patient has been enrolled in the SELUTION4SFA sirolimus drug-eluting balloon (DEB) study by Arthur Lee (Cardiac & Vascular Institute, Gainesville, USA).
This study evaluates SELUTION SLR in the treatment of occlusive disease of the superficial femoral...
“The time has definitely come to look at the evidence, and redo these studies,” posited Alun Davies (Imperial College London, London, UK), putting forward his argument that the NASCET and ECST clinical trials “need to be reconducted” at this...
Vivasure Medical has announced it has enrolled the first patients in the company’s PerQseal PATCH clinical study, a multicentre, single-arm, pivotal study evaluating the safety and efficacy of the Vivasure PerQseal closure device system. The first patients were enrolled...
Cook Medical recently announced that the first patient has been treated in a clinical study to evaluate a new venous valve designed for treating chronic venous insufficiency (CVI). The patient was treated by principal investigator Mauricio Alviar (Clinica de...
Endologix has announced the online publication of the final five-year results of the LEOPARD trial in the Journal of Vascular Surgery (JVS). The study's findings showed that there was no significant difference in aneurysm-related outcomes between patients randomised to...
This advertorial is sponsored by Boston Scientific.
During a recent satellite symposium, which took place at the 2022 Cardiovascular Interventional Radiological Society of Europe (CIRSE) annual meeting (10–14 September, Barcelona, Spain), experts emphasised the clinical value of drug-eluting technologies (DET)...
A question from Manj Gohel (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK) on what the Charing Cross (CX) audience should take back to their multidisciplinary team meetings from the first-time presentation of BASIL-2 led chief investigator Andrew Bradbury...
A debate between two prominent carotid interventionists—Peter Schneider (University of California San Francisco, San Francisco, USA) and Domenico Valenti (King's College London, London, UK)—at the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK) revealed that the vascular...
Penumbra recently announced the launch of the latest addition to its RED family of catheter devices for mechanical thrombectomy, the RED 43 reperfusion catheter.
According to the company, this device is intended to take distal aspiration “to the next level”...
A first-to-podium presentation at the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK) saw Hence Verhagen (Erasmus Medical Center, Rotterdam, The Netherlands) present unique 10-year data from the ENGAGE OUS registry on the Endurant abdominal aortic aneurysm...
This advertorial is sponsored by Gore.
At this year’s Charing Cross (CX) International Symposium (25–27 April, London, UK), Andrew Holden (Auckland City Hospital, Auckland, New Zealand), presented results from the longest follow-up study to date evaluating the GORE® VIABAHN® VBX...
This advertorial is sponsored by Gore.
Even though it is celebrating its aortic portfolio reaching its 25-year milestone, Gore believes that this is only the beginning when it comes to being an aortic ally. The GORE® EXCLUDER® AAA Endoprosthesis and...
This advertorial is sponsored by Gore.
During a satellite symposia at the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK), speakers addressed the “key factor” of conformability in the endovascular repair of multiple vascular pathologies.
First to address the...
Statin treatment after aortic repair is associated with improved long-term survival, while dose does not matter. This was the key message from a first-to-podium presentation delivered by Kevin Mani (Uppsala University, Uppsala, Sweden) at the 2023 Charing Cross (CX)...
A question from Manj Gohel (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK) on what the Charing Cross (CX) audience should take back to their multidisciplinary team meetings from the first-time presentation of BASIL-2 led chief investigator Andrew Bradbury...
Bentley has bought its main supplier, the Switzerland-based Qmedics, Bentley has recently announced in a press release. It also announced its plan of initial public offering (IPO), which is planned for autumn/winter 2023/2024, depending on market conditions.
Qmedics manufactures approximately...
Terumo Aortic today announced the first North American implant of a custom-made hybrid device, Thoracoflo.
A press release notes that the device is used to treat patients with thoracoabdominal aortic disease using a less invasive surgical technique than traditional open...
Surmodics has announced enrolment of the first patient in PROWL, the Pounce thrombectomy system retrospective registry. PROWL is an open-label, retrospective, multicentre US registry of the Pounce system for the non-surgical removal of emboli and thrombi in the peripheral...
Surmodics has announced that Ankur Lodha (Cardiovascular Institute of the South, Lafayette, USA) and Pradeep Nair (Cardiovascular Institute of the South, Houma, USA) were the first physicians to use the company’s Sublime radial access microcatheter.
The Sublime microcatheter is in...
Lithotripsy may hold the key to enabling more carotid artery disease patients who require calcification treatment to undergo stent placement via a transcarotid artery revascularisation (TCAR) procedure, as per single-centre experiences presented at the recent Society for Clinical Vascular...
In this issue:
What to expect from CX 2023
A year in profiles: Alexander Zimmermann, Joseph Coselli, Markus Steinbauer and Jon Boyle
Medical devices: Key updates on regulatory changes in Europe
EVC 2023: STEVECO trial calls into question randomisation in...
In this issue:
What to expect from CX 2023
A year in profiles: Alexander Zimmermann, Joseph Coselli, Markus Steinbauer and Jon Boyle
Medical devices: Key updates on regulatory changes in Europe
EVC 2023: STEVECO trial calls into question randomisation in...
An emerging programme at Houston Methodist aims to help prod those practicing in the vascular surgical space deeper into the field of robotic surgery.
The first ah-ha during a talk at a national meeting being given by one of the...
The Society for Vascular Surgery Vascular Quality Initiative (SVS VQI) clinical registry recently announced it has achieved another milestone, with more than 1,000 centres enlisted in VQI registries. This achievement will strengthen vascular care, improve outcomes and underscore the...
The US launch of a new peripheral intravascular lithotripsy (IVL) catheter, new data on large bore mechanical thrombectomy in high-risk pulmonary embolism (PE) patients, and changes to the EU Medical Devices Regulation (MDR) caught readers’ attention in March.
1. Shockwave...
AVS, an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease with its pulsatile intravascular lithotripsy (PIVL) therapy, has announced that it closed an additional US$8.8 million in new financing, bringing its Series B...
A new investigation into the association between end-stage renal disease (ESRD) and major adverse limb events (MALEs) has found that not only is it strong, but ESRD is particularly associated with below-knee amputation. The details of the study were...
This advertorial is sponsored by Philips.
Two early adopters of Fiber Optic RealShape (FORS; Philips) share their expert opinions on the developing technology, highlighting its future potential in reducing radiation and increasing procedural efficiency.
The European Society for Vascular Surgery (ESVS)...
This educational supplement, sponsored by Artivion, is only available in selected countries and geographies.
The E-liac stent graft system (Artivion/Jotec), according to the clinical data and expert experience, has the potential to overcome the pressing challenge of preserving the...
The CX 2023 Venous & Lymphatic programme is set to be a “highlight” of this year’s meeting, CX co-chair and executive board member Erin Murphy (Sanger Heart and Vascular Institute, Atrium Health, Charlotte, USA) tells Vascular News.
This year’s programme...
“When you save a limb, you save a life” Marianne Brodmann (Graz, Austria) tells CX Live. There are many people who never get seen by a vascular specialist as often there is not a great deal of knowledge among...
Results from the PROMISE II pivotal trial investigating transcatheter arterialisation of the deep veins using the LimFlow system in so-called no-option chronic limb-threatening ischaemia (CLTI) patients were today published in the New England Journal of Medicine (NEJM).
The publication confirmed...
Dual antiplatelet therapy (DAPT) has demonstrated improved clinical outcomes, including reduced in-hospital stroke and mortality risks, compared to other medication regimens in carotid artery disease patients who undergo stent placement via a transcarotid artery revascularisation (TCAR) procedure.
This is the...
Joseph Coselli (Houston, USA) reflects on the return of in-person meetings and the value they offer in terms of exchanging new information, learning from other healthcare professionals, expanding collective knowledge of the field and ultimately “improving what physicians can...
Tilo Kölbel (Hamburg, Germany) speaks to CX Live about new, innovative developments within devices and recent results of large studies producing data that poses “interesting” updates to the field of vascular surgery.
Focusing in on the aortic community and areas...
Navigating cases of abdominal aortic aneurysm (AAA) with short neck anatomy pose a serious challenge to vascular surgeons, but the list of potential options available to carry out repairs are numerous—and decision-making can be optimised by using a bespoke...
W L Gore & Associates (Gore) has announced that the first US patient has been enrolled in a prospective, non-randomised, multicentre, single-arm study with five-year follow-up to evaluate the investigational Gore Viafort vascular stent for the treatment of symptomatic...
Data and discussion on revascularisation treatment strategies for patients with chronic limb-threatening ischaemia (CLTI) will take centre stage at the CX 2023 Consensus update, with results from the BASIL-2 (Bypass versus angioplasty in severe ischaemia of the leg-2) randomised...
Palma Shaw (Syracuse, USA) discusses how the World Federation of Vascular Societies (WFVS) collaborates to determine what the key needs for trainees and education across the world are. “We bring global vascular societies together and engage in projects in...
Barbara Rantner (Munich, Germany) talks about the “fantastic experience” of being back in person at CX 2022, where she notes that attendees were able to “meet experts from all over the world” and discuss relevant issues “not only from...
Getinge's iCast covered stent system has received premarket approval from the US Food and Drug Administration (FDA) for the treatment of patients with iliac arterial occlusive disease.
Iliac arterial occlusive disease is a type of peripheral arterial disease (PAD), which...
A recent study comparing outcomes of endovascular aneurysm repair (EVAR) patients has reported no statistically significant differences in mortality or secondary rupture rates between standard Cook, Medtronic and Gore endografts, suggesting similar safety in a real-world setting.
Michael O Falster...
The Society for Vascular Surgery (SVS) and the American College of Surgeons (ACS) have launched the “Vascular Verification Program (Vascular-VP)," an ACS Quality Program developed in partnership with the SVS.
The newly launched inpatient programme reviews not just safety processes...
A range of experts, including Koen Deloose (Dendermonde, Belgium), Thomas Zeller (Bad Krozingen, Germany), Marianne Brodmann (Graz, Austria) and Antonio Micari (Messina, Italy), talk to Vascular News about how the latest data supporting the cost-effectiveness of the IN.PACT Admiral drug-coated balloon...
Viz.ai recently announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its algorithm intended to detect suspected abdominal aortic aneurysm (AAA). Viz AAA is the first FDA-cleared AI-powered solution for the detection and triage of...
Koen Deloose (Dendermonde, Belgium) talks to Vascular News about the key one-year data from the BIOPACT randomised controlled non-inferiority trial, which evaluated the safety and efficacy of the Passeo-18 Lux drug-coated balloon (DCB) catheter (Biotronik) compared to the IN.PACT Admiral...
A total of £10 million has been awarded to the Medicines and Healthcare products Regulatory Agency (MHRA)—an executive agency of the UK Department of Health and Social Care (DHSC)—to help bring innovative new medicines and medical technologies to UK...
Merit Medical has announced the expansion of itsSwiftNinja steerable microcatheter product line. New sizes include a low-profile 2.4Fr distal diameter option in 125-cm and new longer 150-cm lengths.
The 180-degree articulating microcatheter is designed to provide access to challenging peripheral...
Vesteck scientific advisory board members along with key opinion leaders from around the world have successfully completed the first three in-human cases with the Suture-Tight catheter, a press release reports.
Dai Yamanouchi (University of Wisconsin, Madison, USA) and Dainis Krievins...
Shockwave Medical today announced the full US commercial availability of the Shockwave L6 peripheral intravascular lithotripsy (IVL) catheter following clearance by the US Food and Drug Administration (FDA).
A press release details that the Shockwave L6 catheter is purpose-built to...
Vivasure Medical has announced that the US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to advance the company’s PATCH clinical study, a multicentre, single-arm, pivotal study evaluating the safety and effectiveness of the Vivasure...
Armando Mansilha (Porto, Portugal) tells CX Live about the recent publication of the first European training requirements in vascular surgery. Published in International Angiology, the guidance was approved by the (UEMS) comprising 40 national associations and 43 specialist sections...
Recruitment is now complete with more than 100 patients as planned per protocol in the branched endovascular aneurysm repair (BEVAR) study that uses Bentley's BeGraft peripheral Plus balloon expandable covered stent as a bridging stent in complex aortic aneurysms repairs.
Sebastian Büchert...
Distal embolic protection using a filter has been associated with improved transfemoral carotid artery stenting (tfCAS) outcomes in terms of in-hospital stroke and death risks—underpinning current Society for Vascular Surgery (SVS) guidelines recommending routine use of distal embolic protection...
A new study from the University of Sheffield, published in the British Journal of Surgery (BJS), has found clear evidence of socioeconomic disparities in operation rates and survival after surgery for abdominal aortic aneurysm (AAA).
The study, funded by the...
When receiving treatment for abdominal aortic aneurysm (AAA), female patients have a higher risk for kidney damage after endovascular repair, a Michigan Medicine study finds.
Researchers from Michigan Medicine designed an algorithm that can be used prior to endovascular AAA...
Michel Reijnen (Arnhem, The Netherlands) presents the results of a study that sought to assess the potential cost-effectiveness of a urea-based drug-coated balloon (DCB; IN.PACT Admiral, Medtronic) as standard of care treatment for those with chronic limb threatening ischaemia...
Speaking to CX Live, Eric Secemsky (Boston, USA) delves into the emerging use of intravascular ultrasound (IVUS) in the peripheral procedural phases—outlining contemporary studies providing evidence of its benefit, such as the reduction of restenosis risk when IVUS is...
The European Union’s Council of Ministers has today adopted a resolution to extend the deadline for the certification of medical devices under the Medical Devices Regulation (MDR).
Producers of medical devices will have until 31 December 2027 for higher risk...
Data from a new prespecified analysis of the phase III VOYAGER PAD clinical trial show that low-dose rivaroxaban plus aspirin resulted in a 33% reduction in acute limb ischaemia and a 15% reduction in major adverse limb and cardiovascular...
Large bore mechanical thrombectomy with the FlowTriever system (Inari Medical) in patients with high-risk pulmonary embolism (PE) was associated with a significantly lower occurrence of meaningful in-hospital adverse clinical outcomes compared to other contemporary treatments, data presented at the...
Robert A Lookstein, who is executive vice chair, Diagnostic, Molecular and Interventional Radiology at the Icahn School of Medicine at Mount Sinai Hospital (New York, USA) today presented the results of a subanalysis of Thrombolex’s National Heart, Lung and...
In a first-in-human, compassionate-use case approved by the US Food and Drug Administration (FDA), University of Michigan Health (Ann Arbor, USA) interventional radiologists David M Williams and Minhaj S Khaja successfully used VeinWay's Traversa for venous recanalisation to save...
February's top 10 includes the announcement that Abbott is to acquire Cardiovascular Systems, results of the PRESERVE study on the safety and effectiveness of inferior vena cava filters in treating venous thromboembolism, and an interview with past president of...
ReCor Medical and its parent company, Otsuka Medical Devices, recently announced that primary endpoint results from the RADIANCE II pivotal trial were published in the Journal of the American Medical Association (JAMA). Study results showed that the Paradise ultrasound...
As the new kid on the block, endovascular treatment of the common femoral artery (CFA) just does not have that long-term outcome data yet,” Narayanan Thulasidasan (London, UK) tells Vascular News. Thulasidasan discusses some of the benefits of endovascular therapy...
Giacomo Isernia (Perugia, Italy) sits down with Vascular News to discuss the challenges posed by calcium when it comes to endograft delivery. Calcium “limits the ability to choose the proper graft for each patient,” states Isernia. “This is a pity as...
Treatment of common femoral artery (CFA) stenosis, either with an open or endovascular approach, is the subject of much debate, Raphaël Coscas (Paris, France) tells Vascular News at the Paris Vascular Insights (PVI) conference (23–25 November 2022, Paris, France). “Open surgery...
Bella Huasen (Preston, UK) talks to Vascular News about some of the difficulties of treating occlusive disease in the femoropopliteal segment and why it is “essential to have tools that will allow you to deal with these challenges”.
Huasen outlines some of...
This article forms part of an educational supplement sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
Raphaël Coscas (Ambroise Paré Hospital, AP-HP and Paris-Saclay University, Paris, France) illustrates the use and benefits of Shockwave Intravascular Lithotripsy (IVL;...
This article forms part of an educational supplement sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
Giacomo Isernia and Gioele Simonte (Azienda Ospedaliera di Perugia, Perugia, Italy) outline a branched endovascular aneurysm repair (BEVAR) case in...
This article forms part of an educational supplement sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
In this case report, Narayanan Thulasidasan (Guy’s & St Thomas’ NHS Foundation Trust, London, UK) demonstrates how the M5+ Intravascular...
This article forms part of an educational supplement sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
Bella Huasen (Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK) outlines a recent femoropopliteal occlusion case, during which Shockwave Intravascular...
This article forms part of an educational supplement sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
Stefano Fazzini (Tor Vergata Hospital, Rome, Italy) goes into the details and the data behind Shockwave Intravascular Lithotripsy (IVL; Shockwave...
This educational supplement is sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
In this supplement:
Stefano Fazzini (Tor Vergata Hospital, Rome, Italy) goes into the details and the data behind Shockwave Intravascular Lithotripsy (IVL; Shockwave Medical)—a...
Few adverse events are connected to the use of inferior vena cava (IVC) filters to help prevent deep vein blood clots from developing into pulmonary embolisms (PEs), according to the findings of the Predicting the safety and effectiveness of...
David Gillespie (Boston, USA) talks to Vascular News about the PRESERVE study—established by the Society for Vascular Surgery and Society of Interventional Radiology—which is the largest prospective study to investigate real-world outcomes with contemporary use of inferior vena cava...
Humacyte, a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced the publication of “Six-year outcomes of a phase two study of human-tissue engineered blood vessels...
NOTE: This video is ONLY available to watch in selected countries and geographies
Robert Shahverdyan (Hamburg, Germany), Matteo Tozzi (Varese, Italy), Alexandros Mallios (Paris, France), Ounali Jaffer (London, UK) and Narayan Karunanithy (London, UK) each give their take on...
BioGenCell has announced that it is recruiting for an international clinical trial to assess the company's stem cell-based therapy for chronic limb-threatening ischaemia patients who are at risk for limb amputation.
The clinical trial is currently taking place in medical...
Almost one-half of the patients receiving a peripheral vascular intervention (PVI) in the Society for Vascular Surgery (SVS) Vascular Quality Initiative (VQI) registry between 2017 and 2018 were not on guideline-directed medical therapy (GDMT). Kim G Smolderen and Carlos...
Shape Memory Medical has announced the first patient treated in Germany as part of the EMBO postmarket surveillance registry (EMBO-PMS), the company’s prospective, multicentre registry study of its Impede and Impede-FX embolisation plugs when used for peripheral vascular embolisation.
The...
The publication of a consensus statement from the European Society of Cardiology (ESC) Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) is among the final steps in the evaluation of renal denervation as a device-based...
Xeltis has raised €32 million in a Series D2 equity fundraise, backed by a syndicate of current and new investors, which the company says will enable it to progress its clinical programmes into pivotal trials.
Investors include Grand Pharma, DaVita...
Following his 2021–2022 presidency of the Vascular Society of Great Britain and Ireland (VSGBI), Jon Boyle (Cambridge University Hospitals NHS Trust, Cambridge, UK) speaks to Vascular News about his career so far. He also shares his thoughts on the...
W L Gore & Associates today announced that it is initiating the EMBRACE registry to capture real-world data about the Gore Viabahn VBX balloon expandable endoprosthesis used as a bridging stent in conjunction with a branched/fenestrated stent graft.
This multicentre,...
Renal denervation represents another treatment option in patients with uncontrolled resistant hypertension and may be used in selected patients deemed intolerant to antihypertensive drugs.
These are among the messages of a new consensus statement published in EuroIntervention following a review...
NOTE: This video is ONLY available to watch in selected countries and geographies
Iliac side branch devices (ISBs) are “gamechangers in infrarenal therapy of abdominal aortic aneurysms (AAAs),” Mario Lescan (Tübingen, Germany) tells Vascular News. Lescan states that ISBs “allow...
Biotronik has announced the US Food and Drug Administration (FDA) 510(k) clearance and CE mark of its Oscar (One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter.
The company notes in a press release that Oscar is intended for percutaneous...
Prominent venous disease experts discuss venous stenting, appropriate care, and the pursuit of refined data and better education in a space where part of the problem involves practitioners moving “freely from being able to do arterial intervention and suddenly...
In this issue:
CX 2023 preview: Headline peripheral session to spotlight audience view on new BASIL-2 findings
Journal highlight: Individual patient data meta-analysis probes safety of carotid endarterectomy in the elderly
In profile: Jon Boyle (Cambridge, UK)
Andrej Schmidt (Leipzig, Germany)...
In this issue:
CX 2023 preview: Headline peripheral session to spotlight audience view on new BASIL-2 findings
Journal highlight: Individual patient data meta-analysis probes safety of carotid endarterectomy in the elderly
In profile: Jon Boyle (Cambridge, UK)
Andrej Schmidt...
In a recent study of patients with intermittent claudication (IC) caused by isolated superficial femoral artery (SFA) lesions, researchers found that primary stenting conferred benefits in health-related quality of life (HRQoL) at 36 months from treatment compared with best...
Data from the UK-COMPASS trial provide new insights into the management of complex aneurysm treatment in England and, according to lead investigator Srinivasa Rao Vallabhaneni (University of Liverpool, Liverpool, UK), underscore the need for appropriate patient and technique selection...
Cydar Medical recently announced it has successfully completed a US$11.5 million (£9.3 million) Series A funding round including a US$3.7 million (£3 million) cornerstone investment by Pembroke Venture Capital Trust (VCT). The company also revealed that Ken Hitchner has...
Demonstrating the “susceptibility” of care delivery to regional market competition, M Libby Weaver (University of Virginia, Charlottesville, USA) presented the case that intermittent claudication (IC) is a “novel and underdefined” driver of practice variation in management of patients at...
The Magic Touch percutaneous transluminal angioplasty (PTA) sirolimus drug-coated balloon catheter (DCB) has received investigational device exemption (IDE) for the treatment of below-the-knee (BTK) atherosclerotic lesions in peripheral arterial disease (PAD). Concept Medical received its first IDE approval for the...
January's top 10 highlights an individual patient data meta-analysis on the safety of carotid endarterectomy in the elderly and a new randomised trial on the best treatment option for severe occlusive aortoiliac disease among other key updates in the...
Abbott and Cardiovascular Systems (CSI) have announced a definitive agreement for Abbott to acquire CSI. Under terms of the agreement, CSI stockholders will receive US$20 per common share at a total expected equity value of approximately US$890 million.
CSI is...
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In this Vascular News roundtable, Andrew Holden (moderator; Auckland, New Zealand) is joined by Alexandros Mallios (Paris, France), Kate Steiner (Stevenage, UK) and Tobias Steinke (Düsseldorf, Germany) who...
At the 2022 Vascular Society of Great Britain and Ireland (VSGBI) annual scientific meeting (23–25 November, Brighton, UK), Srinivasa Rao Vallabhaneni (University of Liverpool, Liverpool, UK) delivered a first-time presentation of the UK-COMPASS study results. In this interview with Vascular News,...
Northeast Scientific announced this week it has received US Food and Drug Administration (FDA) 510(k) clearance for reprocessing the intravascular ultrasound (IVUS) Eagle Eye Platinum RX digital catheter (Philips).
CEO and founder, Craig Allmendinger shared his thoughts on the impact...
The UK National Vascular Registry (NVR) recently published its 2022 annual report—the 10th since the registry was launched in 2013—highlighting important outcome data for vascular procedures performed in the period between 2019 and 2021.
The report, which was prepared by...
The external validity—in other words, the transferability to real-world clinical practice—of contemporary randomised controlled trials (RCTs) investigating carotid artery stenosis interventions “varies considerably”, as per a recent analysis published in the European Journal of Vascular and Endovascular Surgery (EJVES)...
This advertorial is sponsored by Bentley.
Crossing chronic total occlusion (CTO) lesions are challenging procedures. The BeBack crossing catheter—Bentley’s first product to be available in both Europe and the USA following the company’s acquisition of Upstream Peripheral Medical Technologies’ GoBack...
A systematic review and meta-analysis have demonstrated “convincing evidence” that sex differences exist in carotid atherosclerosis, with all types of plaque features—including those relating to size, composition, and morphology—found to be either larger or more common in men than...
Cagent Vascular has announced the results of a comparative subanalysis of the PRELUDE-below-the-knee (BTK) study versus plain balloon angioplasty.
The study was led by Marianne Brodmann (Medical University of Graz, Graz, Austria). This subanalysis compared their PRELUDE-BTK subset to a...
Mid-term results from a phase II study of surgical bypass using the Human Acellular Vessel (HAV; Humacyte) demonstrated an overall secondary patency rate at 72 months of 60% measured by Kaplan Meier. There was no evidence of graft rejection...
Surmodics recently announced it has received a letter from the US Food and Drug Administration (FDA) related to its premarket approval (PMA) application for the SurVeil drug-coated balloon (DCB).
In the letter, the FDA indicated that the application is not...
A newly published meta-analysis of individual patient data has found that older patients with symptomatic carotid disease are likely to benefit as much from timely intervention as younger patients. Speaking to Vascular News in light of this key finding,...
The UK’s national abdominal aortic aneurysm (AAA) screening programme is fast approaching its 10th anniversary—a milestone that Akhtar Nasim (Sheffield Vascular Institute, Sheffield, Sheffield, UK) and Meryl Davis (Royal Free London NHS Foundation Trust, London, UK) believe provides an...
In a newly released “focused update” to their 2019 recommendations, the European Society for Vascular Surgery (ESVS) abdominal aortic aneurysm (AAA) guidelines writing committee has published advice on the surveillance and management of patients treated with the Nellix endovascular...
Viz.ai has announced the launch of Viz Vascular Suite—artificial intelligence (AI)-powered software enabling vascular care teams to automatically detect and triage care for suspected pulmonary embolism, right heart strain, aortic dissection, and abdominal aortic aneurysm (AAA). The company submitted...
Athanasios Saratzis (University of Leicester, Leicester, UK) speaks to Vascular News about the EVOCC trial, which he hopes will dispel patient and physician “uncertainty” around the best treatment option for severe occlusive aortoiliac disease. This randomised study recently received...
Cardiovascular Systems Inc (CSI) recently announced initiation of the KAIZEN clinical study of its Diamondback 360 peripheral orbital atherectomy system (OAS) for the treatment of calcified plaque in patients with peripheral arterial disease (PAD). The study is intended to...
Medtronic has announced the first patient enrolment in the ADVANCE trial, a head-to-head randomised controlled trial of two leading aortic stent graft systems, the Medtronic Endurant II/IIs stent graft system and Gore Excluder AAA device family systems. The ADVANCE...
Closer ties between cardiologists, cardiac surgeons and vascular surgeons will be a hallmark of the future treatment of diseases of the aorta, a leading figure behind new guidelines for the diagnosis and management of aortic disease tells Vascular News.
Jointly...
Today, Penumbra announced the US Food and Drug Administration (FDA) clearance and launch of its Lightning Flash mechanical thrombectomy system.
"Lightning Flash features Penumbra's novel Lightning intelligent aspiration technology, now with dual clot detection algorithms," the company notes in a...
Lydus Medical is pleased to announce that the Vesseal has received US Food and Drug Administration (FDA) 510(k) clearance. The Vesseal is a microvascular anastomosis suture deployment system, for standardised omnivessel anastomoses, enabling simple, fast, safe, and effective procedures.
An...
AVS has announced that it raised US$20 million in Series B financing, which the company says will accelerate clinical trial timelines for its device for peripheral application in pulsatile intravascular lithotripsy (PIVL) cases and advance development and preclinical work...
Cardiovascular Systems (CSI) announced that Innova Vascular (Innova) has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for its thrombectomy devices intended to treat peripheral vascular disease.
CSI intends to acquire and commercialise each of...
Aisha Shaikh (Memorial Sloan Kettering Cancer Centre, New York, USA) has staked out a claim that, though hypotension was “associated” with arteriovenous access (AV) thrombosis, it should be far from the only consideration in choosing an access modality. She...
ReCor Medical and its parent company Otsuka Medical Devices have announced the appointment of Lara Barghout as president and chief executive officer of ReCor.
Barghout will lead the ReCor business strategy and organisation in the global commercialisation of ReCor’s Paradise...
Despite his initial intention to become a transplant surgeon, Markus Steinbauer (Krankenhaus Barmherzige Brüder, Regensburg, Germany) recalls how the rise of endovascular techniques, and the possibilities for procedural advancement they posed in vascular surgery, led him to change career...
This advertorial is sponsored by Bentley.
Stéphan Haulon (Hôpital Marie Lannelongue, GHPSJ, Paris, France) has extensive clinical experience using the BeGraft (Bentley, Hechingen, Germany) as a bridging stent in fenestrated endovascular aneurysm repair (FEVAR) procedures. He has conducted a pioneering study...
Corindus has been rebranded to Siemens Healthineers Endovascular Robotics and will sit as a dedicated business within the Advanced Therapies area of Siemens Healthineers, the company has announced.
This brand unification is the final step of the company integration process...
VentureMed Group, a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced data presented at the VEITHsymposium, (15–19 November, New York, USA)....
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...
Click the image below to watch CX Aortic Vienna live
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,...
NOTE: This video is ONLY available to watch in selected countries and geographies
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,...
NOTE: This video is ONLY available to watch in selected countries and geographies
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...
NOTE: This video is ONLY available to watch in selected countries and geographies
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...
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