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Humacyte announces positive top line results from Phase 2/3 trial of Human Acellular Vessel...
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...
Clinical performance of Human Acellular Vessel amid war in Ukraine presented at military research...
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...
Humacyte completes enrolment in Phase II/III trial of Human Acellular Vessel for vascular trauma...
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)...
Shockwave IVL can preserve patients’ future options by increasing vessel wall compliance
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...
Humacyte publish six-year outcomes in study of HAV for peripheral arterial bypass
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...
Human-tissue engineered blood vessels remain durable at six years in PAD patients, latest study...
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...
“Impressive” 12-month Flex vessel prep data presented at VEITHsymposium
VentureMed Group, a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of...
Vivasure Medical announces Series D financing to advance portfolio of PerQseal vessel closure devices
Vivasure Medical has announced the closing of the first tranche of €22 million (US$23 million) as part of its Series D financing round that...
Humacyte’s Human Acellular Vessel for limb salvage evaluated in multiple complex vascular reconstruction scenarios
Humacyte today announced results from the first series of compassionate use cases of the company’s investigational Human Acellular Vessel (HAV) for the treatment of...
VIVA 2021: IVL “consistently” treats real-world calcium in multiple peripheral vessel beds
An interim analysis from the DISRUPT PAD III observational study showed that intravascular lithotripsy (IVL; Shockwave Medical) performs “consistently well” across challenging peripheral vessels,...
LINC 2021: Three studies evaluating Flex Vessel Prep system presented
VentureMed Group announced today that data from three studies evaluating the use of its Flex Vessel Prep (VP) system were presented during LINC 2021...
Walking can relieve leg pain in people with peripheral arterial disease
Exercise can play an important role in treating peripheral arterial disease (PAD), a recent review from Amy Harwood (Centre for Sport and Exercise Life...
Deep vein arterialisation should be considered in “no option” CLTI patients, two-year Limflow data...
Midterm results from a study of the largest population of patients with no-option chronic limb-threatening ischaemia (CLTI) treated with percutaneous deep vein arterialisation (pDVA)...
Balloon-expandable covered stent reveals promise as endovascular alternative to surgery in treatment of arterial...
This advertorial is sponsored by Bentley.
Maria Antonella Ruffino, a vascular interventional radiologist at Azienda Ospedaliera Universitaria Città della Salute e della Scienza in Turin,...
Intra-arterial calcification poses “one of the biggest challenges” for endovascular therapy
Andrew Holden (Auckland, New Zealand) provides perspective on the first results from the Disrupt PAD III observational registry that were presented at the Charing...
New study points to SFDI as promising technology for assessing patients at risk of...
New evidence supports the utility of spatial frequency domain imaging (SFDI) for identifying compromised circulation in patients at risk of peripheral arterial disease (PAD)....
Smoking cigarettes associated with increased risk of peripheral arterial disease in African Americans
African Americans who smoke cigarettes are more likely than those who do not smoke to develop peripheral arterial disease (PAD), according to new research...
Smoking cigarettes associated with increased risk of peripheral arterial disease in African Americans
African Americans who smoke cigarettes are more likely than those who do not smoke to develop peripheral arterial disease (PAD), according to new research...
Avinger announces 510(k) filing of Pantheris Small Vessel device
Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the Company submitted a new 510(k) application to the US Food &...
First US implants of MicroStent for peripheral arterial disease take place
MicroStent (Micro Medical Solutions), a vascular stent designed to reduce below-the-knee amputations caused by critical limb ischaemia (CLI) resulting from peripheral arterial disease (PAD)...
XableCath granted US patent for its peripheral arterial catheters
The second patent for peripheral artery disease-focused device company XableCath has been granted in the USA. The new patent specifically describes a catheter that controls...
Next-generation stent systems for lower extremity arterial occlusive lesions
Balloon angioplasty has been utilised in lower extremity revascularisation procedures since the 1970s, but the durability of this technique is limited by both mechanical...
Using the Tack endovascular system to treat vessel dissection
At LINC 2017 Vascular News spoke to Peter Schneider (Kaiser Foundation Hospital, Honolulu, Hawaii, USA) about the Tack endovascular system (Intact Vascular), an implant designed to repair...
Humacyte commences US phase II arterial bypass clinical trial
Humacyte has announced the initiation of a US phase II arterial bypass clinical trial of Humacyl, an investigational human acellular vessel, to test its safety...
Shockwave Medical announces positive study results of Lithoplasty system for peripheral arterial disease
Shockwave Medical has announced positive clinical results from the pooled DISRUPT PAD Study, a single-arm, two-phase multicentre study evaluating the safety and performance of...
Spiral flow may be key to improving peripheral arterial stent performance
A review of haemodynamics in stent development, published in Annals of Biomedical Engineering, suggests that the re-introduction of spiral flow after endovascular treatment for...
REALITY study will evaluate use of directional atherectomy and drug-coated balloon in peripheral arterial...
Medtronic announced on 2 November 2015 the initiation of the REALITY Study (Directional atherectomy + drug-coated balloon to treat long, calcified femoropopliteal artery stenoses)...
Multimodality imaging study first to use PET-CT in peripheral arterial disease
A new study shows that positron emission tomography-computed tomography (PET-CT) can be performed in peripheral arteries "with strong reliability", according to the investigators.
Covidien Stellarex drug-coated angioplasty balloon receives CE mark to treat peripheral arterial disease patients
The Stellarex drug-coated angioplasty balloon (Covidien) is used to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial disease.
Bioengineered blood vessels in early clinical trials: Potential new option for dialysis patients
By Jeffrey H Lawson
Recent advances in tissue engineering have led to an investigational off-the-shelf bioengineered blood vessel for implantation and provide vascular access for...
DNA therapy and electroporation provides significant effects on peripheral arterial disease
A new application of Cellectra electroporation technology (Inovio) could dramatically enhance the ability of DNA therapy to stimulate blood vessel growth and recovery from debilitation caused by peripheral arterial disease and critical limb ischaemia.
3D helical stent data suggest correlation between stented vessel curvature and primary patency
Results from the MIMICS study have shown a 12-month Kaplan Meier estimate of freedom from clinically driven target lesion revascularisation of 91.2% for patients treated with the new BioMimics 3D stent.
Paclitaxel-eluting balloons show favourable outcomes in femoropopliteal arterial disease at two years
The authors of the Italian registry stated that a stent-less therapy approach with a drug-eluting balloon and optimal angioplasty provides favourable outcomes and is likely to leave more interventional options open for the future.
IN.PACT DEEP study of In.Pact Amphirion drug-eluting balloon for peripheral arterial disease completes patient...
"As the largest below-the-knee critical limb ischaemia randomised trial, and the first and only drug-eluting balloon multicentre randomised trial of any kind, IN.PACT DEEP has the potential to shift the treatment paradigm for this challenging patient population," said Iris Baumgartner, one of the principal investigators of the trial.
Apceth starts first phase I/II study on somatic cell therapy for peripheral arterial disease
The study, designed as an open, randomised, single-centre study with two parallel patient groups, will recruit 30 patients by March 2012. Initial results are expected by mid 2012.
Covidien to launch TurboHawk plaque excision system for small vessels
The new system is intended to treat calcified and non-calcified lesion morphologies in small vessels, broadening minimally invasive treatment options for peripheral arterial disease.
Multiple arterial access must be considered in diabetic patients with critical limb ischaemia
Endovascular treatment for arterial recanalisation in diabetic patients with critical limb ischaemia and foot lesions is currently accepted and indicated as the first choice treatment, Marco Manzi told delegates at the VEITHsymposium in New York, USA.
AtheroMed announces launch of EASE clinical trial to evaluate peripheral arterial disease treatment
The company will enrol 90 patients as part of it EASE study to allow an evaluation of the safety and effectiveness of the Phoenix Atherectomy catheter.
New introducer product line from St Jude Medical offers reliable access and facilitates arterial...
Engage Family offers physicians state-of-the-art introducers capable of facilitating both femoral and radial access.
BD announces 510(k) clearance of expanded indications for the Rotarex atherectomy system
BD recently announced it has received 510(k) clearance for expanded indications from the US Food and Drug Administration (FDA) for the Rotarex atherectomy system.
The...
LINC 2021: New data show potential of Limflow system to improve outcomes for no-option...
In a late-breaking trial session at LINC 2021 (The Leipzig Interventional Course, 25–29 January, online), key updates on below-the-knee (BTK) interventions were in the spotlight. Speaking during his...
BELONG study enrols first patients
Enrolment of the first patients in the BELONG study—benefit of arterial vessel preparation by arterial by longitudinal micro-incisions before drug-eluting balloon angioplasty of the...
TOBA II trial meets primary and secondary endpoints at one-year
The Tack Optimized Balloon Angioplasty II (TOBA II) clinical trial has successfully achieved both primary and secondary endpoints. One year results from the TOBA...
Philips announces the relaunch of the Pioneer Plus catheter
Philips has announced the relaunch of its Pioneer Plus catheter, “the first and only re-entry device with intravascular ultrasound (IVUS) capabilities and needle deployment designed...
Jotec to launch new E-vita abdominal XT stent graft system
According to Jotec, the E-vita abdominal XT device offers a new designed multifunctional wire-reinforced catheter with high flexibility in the proximal part and outstanding pushability in the distal portion without any risk of kinking.
Laminate Medical announces FDA clearance for VasQ AVF creation device
Laminate Medical Technologies has announced their flagship device, the VasQ External Vascular Support, has been cleared by the US Food and Drug Administration (FDA)...
Deep venous valve technologies set to address “large unmet need worldwide”
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...
Promising future previewed for PAD treatment at Riga summit
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,...
Timeline: Key milestones in the paclitaxel story
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...
RECOIL study: Serranator demonstrates 49% less recoil than plain balloon angioplasty in BTK arteries
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...
Surmodics receives FDA approval for the SurVeil drug-coated balloon
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...
Surmodics receives 510(k) clearance for Pounce LP thrombectomy system
Surmodics announced in a press release that it has received US Food and Drug Administration (FDA) 510(k) clearance for its Pounce LP (low...
Biotronik launches Oscar multifunctional peripheral catheter at LINC 2023
Biotronik today announced the limited release of its Oscar (One Solution: Cross. Adjust. Restore) multifunctional peripheral catheter and start of promotional activities at this...
Penumbra expands computer-aided thrombectomy offering with Lightning Bolt 7 launch
Penumbra has announced the US Food and Drug Administration (FDA) clearance and launch of Lightning Bolt 7, which the company claims is the most...
Adding 8–12mm diameter devices to the Shockwave Peripheral Intravascular Lithotripsy toolkit
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...
Shape Memory Medical announces publication of study results
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...
Artificial intelligence could enable life-saving early diagnosis and advance the treatment of pulmonary hypertension
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...
MagicTouch sirolimus-coated balloon granted IDE approval for treatment of the SFA
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)...
First US patient enrolled in MedAlliance sirolimus DCB study
The first US patient has been enrolled in the SELUTION4SFA sirolimus drug-eluting balloon (DEB) study by Arthur Lee (Cardiac & Vascular Institute, Gainesville, USA)....
Vivasure Medical announces first enrolment in pivotal PATCH study
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...
Surmodics announces successful first patient use of Sublime radial access microcatheter designed for the...
Surmodics has announced that Ankur Lodha (Cardiovascular Institute of the South, Lafayette, USA) and Pradeep Nair (Cardiovascular Institute of the South, Houma, USA) were...
Shockwave Medical announces US launch of new peripheral IVL catheter
Shockwave Medical today announced the full US commercial availability of the Shockwave L6 peripheral intravascular lithotripsy (IVL) catheter following clearance by the US Food...
Vivasure Medical announces FDA IDE approval to initiate US pivotal study
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...
Shockwave IVL: A paradigm shift in the treatment of common femoral artery lesions
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...
Shockwave IVL: The last piece of the puzzle to overcome the challenge of hostile...
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...
Shockwave IVL: Sound science reinforced by sound evidence
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,...
Change compliance to change the game in PAD treatment: Overcome the challenge of calcium...
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,...
Cardiovascular Systems enrols first patient in Japan for KAIZEN clinical study
Cardiovascular Systems Inc (CSI) recently announced initiation of the KAIZEN clinical study of its Diamondback 360 peripheral orbital atherectomy system (OAS) for the treatment...
Efemoral Medical closes financing round to fund ongoing study of its vascular scaffold system
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...
Vascular News’ top 10 most popular stories of November 2022
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...
VentureMed to present new data on DCB treatment for PAD
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...
Chocolate Touch drug-coated angioplasty balloon for treatment of PAD receives FDA approval
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)...
Disrupt PAD III observational study results confirm safety and effectiveness of IVL in complex...
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...
SIRONA trial enrolment completed
Concept Medical has announced the successful completion of enrolment for the SIRONA randomised controlled trial (RCT) investigating the use of its Magic Touch PTA...
Transit Scientific announces US FDA clearance for XO RX angioplasty platform
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...
Concept Medical’s SIRONA trial completes enrolment
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...
Sirolimus-coated balloon a “clear alternative” to paclitaxel-coated balloons
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...
Penumbra and Asahi Intecc partner to introduce Indigo System to Japan
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...
ESVS publishes “pioneering” clinical practice guidelines on radiation safety
The European Society for Vascular Surgery (ESVS) has released clinical practice guidelines on radiation safety, which the writing committee notes are the first guidelines...
SAVAL trial finds no gains with custom drug-eluting stents in PAD below the knee
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...
Vascular News’ top 10 most popular stories of August 2022
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...
Vascular experts establish appropriate use of IVUS in peripheral interventions
Royal Philips today announced an important milestone in the evolving standard of care for treating patients with peripheral vascular disease: the establishment of the...
Vascular News’ top 10 most popular stories of July 2022
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,...
Selution SLR receives second FDA IDE approval
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...
First patients enrolled in LIMES randomised trial of Magic Touch sirolimus-coated balloon in BTK...
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...
Northeast Scientific receives 510(k) for Turbo-Elite laser atherectomy catheter reprocessing
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...
New project set to develop nanoparticles with imaging and medicine-delivery capabilities to better treat...
A University of Texas at Arlington (UTA; Arlington, USA) bioengineer is leading a project that will develop biodegradable nanomaterials that will take pictures and...
Shockwave IVL: Maintaining options for patients with calcified PAD
Intravascular Lithotripsy (IVL; Shockwave Medical) gives physicians “the option to treat a patient efficiently without implanting something like a stent, which would limit further...
Philips announces positive three-year clinical research results from its TOBA II BTK clinical trial
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...
Vascular News’ top 10 most popular stories of May 2022
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...
Medtronic gains FDA approval for IN.PACT 018 DCB
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...
Shockwave IVL maintains superiority to angioplasty in calcified peripheral disease at two years
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...
Case report: Aspirex™S enables treatment of thrombosed prosthetic arteriovenous grafts
This advertorial, sponsored by BD, is only available in selected countries and geographies.
“Percutaneous mechanical thrombectomy debulks thrombus load, leading to rapid revascularisation for...
Investigator-initiated studies pave the way for on-label bridging stent use in complex aortic procedures
This advertorial is sponsored by Bentley.
Bridging stents have been used in fenestrated and branched endovascular aneurysm repair (F/BEVAR) for many years. However, their use...
Pounce thrombectomy system first-in-human data show 100% technical success in early cases
Surmodics has announced that its Pounce thrombectomy system achieved 100% technical success in 20 first-in-human (FIH) procedures. The FIH data were presented by Gary...
Five-year patient-level data confirm safety of Passeo-18 Lux paclitaxel DCB
New long-term data presented at the 2022 Charing Cross (CX) Symposium (26–28 April, London, UK) demonstrate the safety of Biotronik’s Passeo-18 Lux paclitaxel drug-coated...
Vascular News’ top 10 most popular stories of March 2022
A review of intraoperative adverse events in patients treated with fenestrated and branched endovascular aneurysm repair, meta-analysis findings on peripheral arterial disease symptoms in...
Shockwave Medical announces global launch of new peripheral IVL catheter
Shockwave Medical has announced the global commercial availability of the Shockwave M5+ peripheral intravascular lithotripsy (IVL) catheter after receiving both CE mark and US...
Humacyte announces publication of positive long-term follow-up data from phase 2 trial of HAV...
Humacyte today announced that five-year data from a phase 2 clinical trial of patients receiving the investigational Human Acellular Vessel (HAV) for arteriovenous (AV)...
Medtronic recalls HawkOne directional atherectomy system due to risk of tip damage during use
According to the US Food and Drug Administration (FDA), Medtronic is recalling its HawkOne directional atherectomy system.
The FDA has identified the recall as a...
Shockwave Medical enrols first patient in Disrupt BTK II study for long, calcified, below-the-knee...
Shockwave Medical has announced the start of the Disrupt BTK II postmarket study to assess the safety, effectiveness and optimal clinical use of the...
Avinger announces FDA clearance of Pantheris for the treatment of in-stent restenosis
Avinger recently announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for a new clinical indication for the...
First patient treated with Cardiovascular Systems’ ViperCross peripheral support catheter
Cardiovascular Systems recently announced that the first patient has been successfully treated with its ViperCross peripheral support catheter.
Billy J Kim (The Surgical Clinic, Nashville,...
Surmodics announces successful first patient uses of Sublime radial access 0.018 RX PTA dilatation...
Surmodics today announced the successful first clinical uses of the Sublime radial access 0.018 RX percutaneous transluminal angioplasty (PTA) dilatation catheter.
Ankur Lodha, perfomed the...
Boston Scientific announces agreement to acquire Devoro Medical
Today, Boston Scientific announced an agreement to acquire Devoro Medical, developer of the Wolf thrombectomy platform. The non-console and lytic-free Wolf technology targets and...
Medtronic receives CE mark for 200mm and 250mm IN.PACT Admiral DCBs
Medtronic has announced CE mark approval and the European launch of the 200mm and 250mm IN.PACT Admiral drug-coated balloons (DCBs). The product is intended...
Singapore researchers develop novel 3D model to study vascular diseases
A Singapore team of scientists and clinicians from Nanyang Technological University, Singapore (NTU Singapore) and Tan Tock Seng Hospital (TTSH), have developed a three-dimensional...
R3 Vascular reports the initiation of its first-in-human clinical study
R3 Vascular has reported the successful initiation of its first-in-human clinical study evaluating the technical and clinical performance of the R3 Vascular Magnitude bioresorbable...
Case report: Recanalisation of chronic iliofemoral venous occlusion in a patient with PAD and...
This advertorial, sponsored by BD, is only available in selected countries and geographies.
In this case report for Vascular News, experts outline the importance...
Terumo introduces Azur vascular plug and PG Pro peripheral microcatheter embolisation system
Terumo Medical Corporation has announced today the introduction of its Azur vascular plug. The addition to Terumo's embolisation portfolio is indicated for use to...
Sectoral Asset Management makes US$9 million investment into Cagent Vascular
Cagent Vascular recently announced the investment of US$9 million by Sectoral Asset Management. Along with the investment, Marc-Andre Marcotte has joined the board of...
Philips announces positive two-year data from TOBA II BTK clinical trial
Royal Philips recently announced positive two-year results from the TOBA (Tack optimised balloon angioplasty) II below-the-knee (BTK) clinical trial.
The data show the Philips...
Vascular News’ top 10 most popular stories of May 2021
Expanding eligibility for endovascular aneurysm repair (EVAR), new tools for chronic limb-threatening ischaemia (CLTI), and promising data for arteriovenous (AV) fistula remote monitoring all...
XO Score scoring sheath platform wins medical design award
Transit Scientific today announced that its XO Score scoring sheath platform has been named a winner in the 2021 Medical Design Excellence Awards (MDEA)....
“A new look at laser”: Positive initial data presented at ISET for the Auryon...
The Auryon atherectomy system (AngioDynamics) “represents an exciting new technology”, John Rundback (Advanced Interventional and Vascular Services, LLP, Teaneck, USA) opined at the International...
New tools for CLTI: ISET audience hear what’s on the horizon for these challenging...
“I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider (University of California San Francisco, San Francisco,...
New tools for CLTI: ISET audience hear what’s on the horizon for these challenging...
“I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider (University of California San Francisco, San Francisco,...
Micro Medical Solutions receives FDA breakthrough device designation for MicroStent vascular stent
Micro Medical Solutions (MMS) recently announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its MicroStent vascular stent....
Micro Medical Solutions receives FDA breakthrough device designation for MicroStent vascular stent
Micro Medical Solutions (MMS) recently announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its MicroStent vascular stent....
BlueDop Vascular Expert provides actionable information to revolutionise patient triage
Patrick Kelly (Sioux Falls, USA) and Peter Schneider (San Francisco, USA) discuss a novel technology from BlueDop Medical that uses a patented process to...
Penumbra announces US commercial availability of Indigo system Lightning 7
Penumbra today announced US commercial availability of the Indigo system Lightning 7. Lightning 7 expands Penumbra’s offering of the Indigo aspiration system with Intelligent...
Case report: Complex endovascular treatment for an iliac artery occlusion using the LifeStream™ balloon-expandable...
This advertorial, sponsored by BD, is only available in selected countries and geographies.
Martin Schroeder—a vascular surgery specialist at the Ruhr University Bochum Marienhospital...
First patient enrolled in SUCCESS PTA post-market study of Selution drug-eluting balloon
MedAlliance has announced enrolment of the first patient in SUCCESS PTA, its large post-market study with the drug-eluting balloon Selution SLR for the treatment...
LINC 2021: Novel approaches and new data for BTK interventions revealed
In a late-breaking trial session at LINC 2021 (The Leipzig Interventional Course, 25–29 January, online), key updates on below-the-knee (BTK) interventions were in the...
LINC 2021: PRELUDE-BTK results confirm Serranator device novel mechanism of action
Cagent Vascular announced the results of its PRELUDE-BTK study at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online). The PRELUDE-BTK study was a...
LINC 2021: Long-term data show sustained efficacy and safety of paclitaxel devices in femoropopliteal...
A key theme among the late-breaking trial data presented at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online) was the emergence of long-term...
VasQ device improves AVF creation in haemodialysis patients
VasQ, a high haemocompatibility biosynthetic vascular device from Laminate Medical Technologies, could be protective against the haemodynamic modifications that occur during arteriovenous fistulae (AVF)...
Okami Medical announces FDA 510(k) clearance of the LOBO-5 vascular occluder
Okami Medical has revealed the expansion of its LOBO vascular occlusion system product line with US Food and Drug Administration (FDA) 510(k) clearance of...
Efemoral Medical announces successful first-in-human use of the Efemoral vascular scaffold system
Efemoral Medical has announced the first-in-human (FIH) use of the company's Efemoral vascular scaffold system (EVSS) with FlexStepv technology in the EFEMORAL I FIH...
Penumbra’s newest generation of Indigo aspiration system receives FDA clearance for pulmonary embolism
Penumbra today announced US Food and Drug Administration (FDA) 510(k) clearance for expanded indication of the latest iteration of the Indigo aspiration system, Lightning...
First procedures performed with Transit Scientific’s XO Score angioplasty system
According to a press release, Transit Scientific's XO Score system has been successfully used to dilate multiple challenging fibrotic and calcific lesions in haemodialysis...
RCT investigating use of MagicTouch PTA sirolimus-coated balloon for PAD enrols first patient
Concept Medical has announced the enrolment of the first patient in the SirPAD (Sirolimus in peripheral arterial disease) trial. According to a press release,...
DISRUPT PAD III: Intravascular lithotripsy superior to PTA in acute procedural success out to...
The DISRUPT PAD III randomised controlled trial (RCT) provides the largest level one evidence for the treatment of heavily calcified femoropopliteal arteries, noted William...
Directional atherectomy prior to IN.PACT DCB effective out to one year, REALITY finds
A vessel preparation treatment strategy of directional atherectomy prior to drug-coated balloon angioplasty with Medtronic’s IN.PACT Admiral drug-coated balloon (DCB) in long, calcified femoropoliteal...
Boston Scientific receives FDA approval for the Ranger DCB
Boston Scientific announced it has received US Food and Drug Administration (FDA) approval of the Ranger drug-coated balloon (DCB), developed for the treatment of...
“Starting to close the door on the paclitaxel controversy”: Late-breaking trials presented at TCT...
Findings from a series of late-breaking trials in the endovascular field were presented recently at TCT Connect (14–18 October, virtual), the 32nd annual scientific...
R3 Vascular completes Series A financing
R3 Vascular recently announced closing of its Series A financing round, including new equity investments of US$15 million and the conversion of US$2.8 million...
Alucent Biomedical announces US$35 million Series B financing
Alucent Biomedical recently announced the close of a US$35 million Series B financing round led by a large multinational strategic investor and joined by...
Vascular surgeons encouraged to consult talking points document on paclitaxel devices
Vascular surgeons are being encouraged to take consideration of a set of talking points about the risks and benefits of paclitaxel-equipped devices—which has developed...
Philips launches QuickClear mechanical thrombectomy system for blood clot removal in latest portfolio expansion
Royal Philips has announced the launch of the QuickClear mechanical thrombectomy system. The single-use system delivers an all-in-one aspiration pump and catheter to remove...
First patient enrolled in FUTURE SFA study of MagicTouch sirolimus-coated balloon
Concept Medical has announced the enrolment of the first patient in the FUTURE SFA (Randomised controlled trial of first sirolimus coated balloon versus standard...
Enrolment initiated in world’s first RCT with sirolimus-coated balloon for below-the-knee PAD treatment
Concept Medical has announced the enrolment of the first patient in the FUTURE BTK (Randomised controlled trial of first sirolimus-coated balloon versus standard balloon...
Philips to expand its image-guided therapy portfolio through acquisition of Intact Vascular
Royal Philips today announced that it has signed an agreement to acquire Intact Vascular. According to a press release, Intact Vascular will enhance Philips’...
PRIZER, new multicentre PAD study, launches
A new post-market study investigating the effectiveness of the Renzan peripheral stent system (Terumo) in patients with peripheral arterial disease (PAD) has been...
iVascular launches Sergeant peripheral support catheter
iVascular recently announced the launch of its Sergeant peripheral support catheter. Sergeant is a CE marked over-the-wire catheter, indicated for patients with peripheral arterial...
Intact Vascular announces positive one-year data from TOBA II BTK clinical trial
Intact Vascular announced the positive one-year results from its Tack optimised balloon angioplasty (TOBA) II BTK clinical trial during the 2020 Vascular Interventional Advances (VIVA)...
CX 2020 LIVE audience delivers resounding vote in favour of fibre optic visualisation
For the CX 2020 LIVE Aortic Podium 1st Session, 489 participants from 62 countries tuned in to hear a series of experts examine technological...
Enrolment begins in DEEPER LIMUS study of Reflow Medical’s Temporary Spur stent system
The first patients have been enrolled in the single-centre DEEPER LIMUS clinical trial, Reflow Medical has announced. The non-randomised pilot study will evaluate the...
CX 2020 LIVE: Vascular Access session showcases new technologies, while debate on place of...
The CX 2020 LIVE Vascular Access Consensus session sparked global interest, with chair Nick Inston (Birmingham, UK) and moderator Domenico Valenti (London, UK) taking...
CX 2020 LIVE: Strong support for relining peripheral arteries and rivaroxaban use for widespread atherosclerosis
In a series of Podium 1st presentations from world-class faculty, CX 2020 LIVE attendees heard the latest data on peripheral arterial disease management and an evaluation of different types of stents, including...
FDA clears Transit Scientific’s XO Score PTA scoring sheath platform
Transit Scientific has received US Food and Drug Administration (FDA) clearance for the XO Score percutaneous transluminal angioplasty (PTA) scoring sheath platform for use...
TOBA III clinical trial results published in the Journal of Vascular Surgery
Intact Vascular has announced the peer-reviewed publication of its Tack optimised balloon angioplasty (TOBA) III 12-month clinical trial results in the Journal of Vascular Surgery.
The multi-centre, single-arm,...
Pedal artery revascularisation: Is it ready for prime time?
Reviewing the available evidence for below-the-ankle interventions in the treatment of critical limb-threatening ischaemia (CLTI), Srini Tummala proposes that pedal artery intervention “should be...
A Deeper Dive into the Venovo™ Venous Stent System
Vascular News talks with Gerard O'Sullivan, FSIR, FEBIR, University College Hospital, Galway, Ireland. This article is supported by BD Interventional.
Disclosures: Dr. Gerard O'Sullivan reports...
Okami Medical announces first patients treated with Lobo vascular occluder
Okami Medical has announced the successful completion of the first cases with the Lobo vascular occlusion system. The first offering in the company's product...
Enrolment of the VasQ external support US pivotal study now complete
Laminate Medical Technologies has announced the completion of enrolment into the VasQ external support US pivotal study. The study was conducted at 17 sites...
Intact Vascular expands Tack Endovascular System portfolio offering
Intact Vascular has announced US Food and Drug Administration (FDA) pre-market approval (PMA) for the expansion of its Tack Endovascular System (6F) portfolio. The...
Ra Medical Systems receives FDA IDE approval to begin pivotal atherectomy clinical study
Ra Medical Systems has announced approval from the US Food and Drug Administration (FDA) that the company has provided sufficient data to support initiating...
Alucent Biomedical announces FDA approval to proceed with natural vascular scaffolding clinical trial
Alucent Biomedical has received US Food and Drug Administration (FDA) approval to proceed with a phase 1 clinical trial to evaluate the safety and...
FDA clearance granted to Penumbra for Indigo Aspiration System
Penumbra has announced US Food and Drug Administration (FDA) 510(k) clearance for expanded indication of the Indigo Aspiration System. As part of the system,...
FDA grants breakthrough device designation to Reflow Medical’s Temporary Spur stent system
Reflow Medical announces that the Temporary Spur stent system, a novel retrievable stent technology intended for the treatment of below-the-knee (BTK) peripheral arterial disease,...
Wound care specialists can improve microcirculation by maximising “the overall vascular health of patients”
Wound care specialists can improve microcirculation by maximising “the overall vascular health of patients” It is the refrain William Ennis (University of Illinois, Chicago,...
Endovascular arteriovenous fistulas “key part of any dialysis programme”
Endovascular arteriovenous fistulas (endoAVF) platforms add additional fistula options for patients and physicians, argues Dheeraj Rajan (University Health Network, University of Toronto, Toronto, Canada,...
Teamwork prescribed to tackle major demographic trends in vascular disease
“Caring for vascular patients is going to take a team,” concluded Marc Bonaca (Boston, USA) at the 2019 Vascular Interventional Advances (VIVA) conference in...
VIVA 2019: Revolution system meets primary and safety endpoints in REVEAL study
Findings from the REVEAL study confirm a favourable safety and effectiveness profile through six months for the Revolution peripheral atherectomy system from Rex Medical....
VIVA 2019: Boston Scientific announces positive data for the Ranger DCB and the Eluvia...
Boston Scientific today announced positive data for two devices within the peripheral drug-eluting product portfolio during separate late-breaking clinical trial presentations at the 2019...
Okami Medical announces FDA 510(k) clearance and patent for the LOBO vascular occluder
Okami Medical today announced 510(k) clearance by the US Food and Drug Administration (FDA) and initial launch of the LOBO vascular occlusion system.
The company...
Sundance sirolimus-coated balloon catheter granted FDA breakthrough device designation
Surmodics has announced that the US Food and Drug Administration (FDA) has designated its Sundance sirolimus-coated balloon catheter as a breakthrough device under the...
The retrograde approach to chronic total occlusions
Lorenzo Patrone talks to Vascular News about retrograde access to lower limb arterial chronic total occlusions (CTOs).
What
The retrograde approach to lower limb arterial...
Philips receives FDA approval for low-dose drug-coated balloons
Philips has received US Food and Drug Administration (FDA) approval for two Stellarex 0.035” low-dose (200mm and 150mm) drug-coated balloons for the treatment of...
Superior clinical outcomes for endovascular therapy candidates triaged directly to a comprehensive stroke centre
For patients with emergent large vessel occlusion (LVO) eligible for endovascular therapy, prehospital triage to a more distant comprehensive stroke centre (CSC) compared with...
OUTBACK™ Elite Re-entry catheter highly effective at saving limbs in extreme CTOs
Lorenzo Patrone (London, UK) shares with BLearning at CIRSE 2019 (7–11 September, Barcelona, Spain) the benefits of using the OUTBACK™ Elite Re-entry Catheter (Cordis,...
Intact Vascular announces positive one-year data from TOBA III clinical trial
Intact Vascular has announced the positive one-year results of its Tack Optimised Balloon Angioplasty (TOBA) III clinical trial, successfully achieving both primary and secondary...
Rex Medical receives 510k clearance for Revolution Peripheral Atherectomy System
Rex Medical recently announced that it has received 510k clearance from the US Food and Drug Administration (FDA) for the Revolution Peripheral Atherectomy System.
Regulatory...
CIRSE 2019: New data show high chronic outward force causes significantly more restenosis
Twelve-month results of the BIOFLEX COF trial have demonstrated that the implantation of stents with low chronic outward force (COF) was associated with less...
“More creative solutions” needed for end-stage vascular access patients
Nicholas (Nick) Inston calls for “more creative solutions” to vascular access challenges, commending interventional radiologists’ innovative reputation as instrumental to increasing the number of...
US e-cigarette study confirms impact of vaping on vascular function
Inhaling a vaporised liquid solution through an e-cigarette, also known as vaping, immediately impairs vascular function, even when the solution does not include nicotine,...
MagicTouch PTA sirolimus coated balloon granted breakthrough device designation by FDA
Concept Medical has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for its MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus...
Reflow Medical enrols first patients in DEEPER OUS Spur stent trial
Reflow Medical, Inc announces that the first patients have been enrolled in its DEEPER OUS clinical trial using the Temporary Spur Stent System.
DEEPER OUS...
NuCryo Vascular announces commercialisation agreement with Lokai Medical
NuCryo Vascular has announced that the company has signed a commercialisation agreement with Lokai Medical, a specialty distributor of coronary/peripheral and interventional devices, to...
US FDA grants IDE approval for pivotal clinical trial of MicroStent
Micro Medical Solutions has received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA). IDE approval allows the company to...
US FDA panel reviews paclitaxel device data: No recommendations issued, as more work is...
The US Food and Drug Administration (FDA) convened this week for a General Issues Panel Meeting on the late mortality safety signal associated with...
BD receives FDA approval for expansion to drug-coated balloon product line
The US Food and Drug Administration (FDA) has approved expanded sizes of the Lutonix 018 drug-coated balloon (DCB) to treat long superficial femoral artery...
iWounds Workshop debut at CX 2019
The 2019 Charing Cross Symposium (CX; 15–18 April, London, UK) saw the introduction of a new strand of care with the debut of the...
The reactive and repetitive multidisciplinary CLI team
It is imperative that every medical institution has an interdisciplinary CLI team, argues Jihad Mustapha. Here, he exhorts the benefits of working in such...
BIOPACT-RCT set to compare Passeo-18 Lux and IN.PACT Admiral DCBs in head-to-head
iD3 Medical has announced that it has received approval in Belgium to initiate a randomised controlled trial, BIOPACT-RCT: a physician-initiated multicentre trial evaluating the...
Tack Endovascular System launches in the USA, first commercial use announced
Intact Vascular has announced the first commercial use of its Tack Endovascular System in multiple sites across the USA. Recently FDA-approved for above-the-knee interventions,...
iWounds Workshop debut at CX 2019
The 2019 Charing Cross Symposium (London, UK) saw the introduction of a new strand of care with the debut of the iWounds Workshop to...
Tomographic 3D ultrasound imaging “the way forward” for vascular surgeons
Steven Rogers (Manchester, UK) presented the case for using contrast-enhanced tomographic 3D ultrasound imaging for peripheral arterial disease, telling the audience at Charing Cross...
New MIMICS-2 trial data show helical stents provide durable treatment of diseased femoropopliteal arteries
New data from the MIMICS-2 trial show the BioMimics 3D stent, which mimics natural vascular curvature, remains safe and effective for patients with symptomatic...
Positive outcomes of Eluvia drug-eluting stent in IMPERIAL sub-analyses
Boston Scientific has announced results from sub-analyses of the IMPERIAL clinical trial for the Eluvia Drug-Eluting Vascular Stent System at the 41st Charing Cross...
Intact Vascular’s Tack Endovascular System receives FDA approval
Intact Vascular has announced it received US Food and Drug Administration (FDA) approval for the Tack Endovascular System (6F), a purpose-built dissection repair device implanted...
Avinger receives FDA clearance of Pantheris SV device
Avinger has announced that the company received 510(k) clearance from the US Food & Drug Administration (FDA) for its Pantheris SV (small vessel) image-guided...
UK MHRA forms Expert Advisory Group to review paclitaxel devices while US FDA updates...
The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the Food and Drug Administration (FDA) in the USA have both recently...
“No evidence of increased long-term mortality” with paclitaxel-eluting stent in new JACC analysis
“Drug-eluting stents (DES) are important additions to the armamentarium of devices used for peripheral artery revascularization, associated with decreased rates of restenosis and target...
Alberto Muñoz
Alberto Muñoz tells Vascular News about his 35 years in vascular surgery, including his involvement in the World Federation of Vascular Societies, and discusses...
ISET Paclitaxel Town Hall: Vast majority of attendees will not change their practice following...
The discussion around the use of paclitaxel-coated and eluting devices continues at the 31st International Symposium on Endovascular Therapy (ISET; 27-30 January 2019, Hollywood, USA). Organisers...
Data presented at LINC confirm the safety and effectiveness of Zilver PTX
Findings presented at the Leipzig Interventional Course (LINC; 22–25 January 2019, Leipzig, Germany) contradict the results of a meta-analysis published in the Journal of...
Medtronic and Boston Scientific stand by paclitaxel devices despite Katsanos’ critical study
Speaking to investors at the JP Morgan healthcare conference in San Francisco, executives from Medtronic and Boston Scientific said their data do not show...
Tack Endovascular System launches in the EU with first commercial use in Germany
The first commercial use of the Tack Endovascular System (Intact Vascular) has taken place in multiple hospitals within Germany. A novel therapy for dissection...
TOBA II BTK clinical trial completes enrolment
The Tack Optimised Balloon Angioplasty II below-the-knee (TOBA II BTK) clinical trial has successfully completed enrolment, ahead of schedule. This study, sponsored by Intact...
New ESVS guidelines for management of AAA: What is new and how does it...
The first European Society for Vascular Surgery (ESVS) guideline on treatment of abdominal aortic aneurysm (AAA), published in the European Journal of Vascular and...
Contego Medical receives 510(k) clearance for Vanguard IEP system
Contego Medical has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its Vanguard IEP Peripheral Balloon Angioplasty System...
Meta-analysis finds a higher risk of death in the long term when paclitaxel-coated devices...
New data, just published in the Journal of the American Heart Association (JAHA), suggest that there is an increased risk of death at two...
Vivasure Medical announces launch of the PerQseal large bore closure device
Vivasure Medical has announced the European launch of the PerQseal closure device for large-bore transcatheter procedures, including transcatheter aortic valve implantation (TAVI), thoracic endovascular...
TOBA II shows repairing dissections after angioplasty “clearly augments” outcomes for PAD patients
Thomas Zeller (Bad Krozingen, Germany) delves into data and design of the TOBA II (Tack Optimized Balloon Angioplasty II) trial with principal investigator William...
Similar patency outcomes in women and men treated with Stellarex DCB
A study presented at VIVA 2018 (5–8 November, Las Vegas, USA) by Maureen Kohi, associate professor of Clinical Radiology, University of California, San Francisco,...
12-Month data from PREVEIL study of SurVeil DCB presented at VIVA
Data from the PREVEIL early feasibility study of the SurVeil drug-coated balloon (DCB, Surmodics) were shared in a late-breaking clinical trial presentation at the...
Second iDissection Classification study to evaluate dissection rate of FLEX Dynamic scoring catheter
VentureMed Group has announced the initiation of a new study to determine if the FLEX Dynamic Scoring Catheter reduces dissections and the need for...
Positive outcomes for Eluvia stent in long lesion IMPERIAL sub-study
Clinical outcomes from the IMPERIAL Long Lesion Sub-study were presented at VIVA (5–8 November, Las Vegas, USA) demonstrating that the Eluvia drug-eluting vascular stent...
Humacyte commences phase II vascular trauma trial
Humacyte has announced the initiation of a US phase II vascular trauma clinical trial of Humacyl, its investigational human acellular vessel, for vascular replacement...
Avinger receives CE marking approval for Pantheris SV
Avinger, a developer of treatments for peripheral arterial disease (PAD), has announced Conformité Européenne (CE) Marking approval of Pantheris SV (Small Vessel), a product...
Consider intravascular lithotripsy when treating calcified femoropopliteal arteries
Treating severely calcified arteries by endovascular means is still a challenge, although atherectomy, stents and lithotripsy are all techniques that are employed. Lithotripsy (also...
Intact Vascular announces presentation of TOBA II pivotal data
Intact Vascular has announced that data from its Tack Optimized Balloon Angioplasty (TOBA) II pivotal study will be presented as a late-breaking clinical trial...
Late-breaking trial at CIRSE shows similar outcomes for severely versus non-severely calcified lesions following...
Data from a study seeking to determine the impact of severe calcification and 12-month outcomes of femoropopliteal disease treatment using the Stellarex drug-coated balloon...
Femoropopliteal dissection: Fix or prevent?
In this issue:
– Arterial dissection after balloon angioplasty: an underestimated cause of excessive stenting and patency loss
– Leave nothing behind in the femoropopliteal segment:...
Boston Scientific receives US FDA approval for Eluvia drug-eluting stent
Boston Scientific has announced that the US Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application to market the Eluvia Drug-Eluting...
Eluvia outperforms Zilver PTX in IMPERIAL 12-month results
The Eluvia drug-eluting vascular stent system (Boston Scientific) shows superior primary patency compared to the Zilver PTX drug-eluting stent (Cook Medical), concludes the 12-month...
SAVAL trial of new below-the-knee drug-eluting stent begins
The first patient has been enrolled in the SAVAL pivotal trial to evaluate clinical outcomes of the SAVAL below-the-knee (BTK) drug-eluting stent system (Boston...
Transcarotid artery revascularisation suggests reduced risk of major adverse events compared to standard carotid...
Real-world outcomes from the Transcarotid Artery Revascularisation (TCAR) Surveillance Project (TSP) were presented by Mahmoud Malas from John Hopkins Hospital (Baltimore, USA) at the...
IN.PACT Admiral DCB launched in Japan
Medtronic plc has announced the full commercial launch of the IN.PACT Admiral drug-coated balloon (DCB) in Japan. The launch follows the completion of a...
NuCryo Vascular announces commercialisation agreement with Lokai Medical for PAD treatment
NuCryo Vascular has signed a commercialisation agreement with Lokai Medical, a specialty distributor of coronary/peripheral and interventional devices, to distribute the PolarCath balloon dilatation...
Cagent Vascular raises US$11.87M funding
Cagent Vascular has announced the completion of US$11.87 million in Series B funding. The round was led by two strategic investors including one that...
BD acquires TVA Medical, makers of everlinQ endoAVF System
BD (Becton, Dickinson and Company) announced it has completed the acquisition of TVA Medical, a company that develops minimally invasive vascular access solutions...
BD acquires TVA Medical, makers of everlinQ endoAVF System
BD (Becton, Dickinson and Company) announced it has completed the acquisition of TVA Medical, a company that develops minimally invasive vascular access solutions...
Terumo gets CE mark for Kanshas drug-coated balloon catheter for lower extremities
Terumo has announced that it acquired CE mark for the Kanshas drug-coated balloon catheter used in the treatment of lower extremity peripheral arterial disease....
Humacyte appoints Jeffrey Lawson as president and CEO
Humacyte, an innovator in biotechnology and regenerative medicine, has announced that Jeffrey Lawson has been appointed president and chief executive officer. The former chairman...
Avinger’s next-generation Pantheris Lumivascular atherectomy system gets FDA clearance
Avinger has announced that the company received 510(k) clearance from the US Food & Drug Administration (FDA) for its next generation Pantheris Lumivascular atherectomy...
IJN first in Asia to perform spot stenting procedure with VascuFlex Multi-LOC
Institut Jantung Negara (IJN; Kuala Lumpur, Malaysia) has become the first hospital in Asia to perform peripheral vascular intervention (PVI) using VascuFlex Multi-LOC (B Braun),...
“Fantastic” live case demonstrates potential value of intravascular lithotripsy
In an exciting session at the Charing Cross Symposium (CX; 24-27 April, London, UK), the audience witnessed the demonstration of a novel treatment strategy...
Tack Endovascular System secures US$20 million in premarket approval funding
Intact Vascular, a developer of medical devices for minimally invasive peripheral vascular procedures, has announced that it closed a Series C financing totaling US$20 million....
The value of Swirling Flow and the BioMimics 3D clinical study programme
This article is an advertorial by Veryan Medical.
Authors: PA Gaines, T Sullivan, G Ansel, C Caro
Introduction
Medical advances in the treatment of femoropopliteal artery disease...
TOBA BTK trial study publishes one-year results for Tack endovascular system
The TOBA BTK (Tack Optimized Balloon Angioplasty Below the Knee) clinical trial results have recently been published in Catheterization and Cardiovascular Intervention. The multicentre...
SIR 2018: New biocompatible particle embolic device to slow or stop blood flow
Results and data on vascular embolic device GPX (Fluidx Medical Technology), a new proprietary in situ setting embolic agent that combines the benefits of coils, gel-beads, and...
IN.PACT SFA Japan trial shows significantly higher patency compared with PTA for femoropopliteal lesions
New two-year results from the IN.PACT SFA Japan trial were presented at the Leipzig Interventional Course (LINC; 30 January–2 February, Leipzig, Germany) by Osamu...
Serrenator Alto first-in-man PRELUDE study results presented at LINC 2018
Cagent Vascular, a developer of technology for vessel dilatation in cardiovascular interventions, has announced positive results from the first-in-human PRELUDE study of the company's...
“Promising” 12-month outcomes achieved with the Chocolate Touch drug-coated balloon
The final results of the ENDURE study, investigating the efficacy of the Chocolate Touch drug-coated balloon (QT Vascular), show “promising evidence of the drug...
First patients treated with Avinger’s next generation atherectomy device
Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the first use of their next generation Pantheris lumivascular atherectomy system. The...
Particulate embolisation after femoral artery treatment with drug-coated balloons
Drug-eluting technologies, such as balloons coated with paclitaxel (DCB), are now the gold standard treatment for patients presenting with symptomatic peripheral artery disease (PAD) in the...
TOBA single-centre trial shows 24-month patency rate of 87.5%
Positive single-centre 24-month results from Intact Vascular’s TOBA (Tack optimised balloon angioplasty) clinical study were presented at the 2017 VEITHsymposium 2017 (14–18 November, New York City, USA) by...
Serranator PTA serration balloon catheter receives CE mark
Cagent Vascular has announced the issuance of its CE marking for the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter. Cagent Vascular has also achieved...
Mercator announces completion of enrolment in LIMBO-ATX
Mercator MedSystems has announced completion of enrolment in the company’s LIMBO-ATX (Lower-limb adventitial infusion of dexamethasone via Bullfrog to reduce occurrence of restenosis after...
First patient enrolled in IDE study of the Pantheris system for in-stent restenosis
Avinger has announced initiation of INSIGHT, a prospective, global, single arm, multicentre study to evaluate the safety and effectiveness of the Pantheris Lumivascular Atherectomy...
Essential Medical completes enrolment in US IDE trial of Manta
Essential Medical has announced the completion of enrolment in the US pivotal investigational device exemption (IDE) trial of the Manta large bore vascular closure...
First procedure performed in Rox Medical’s CONTROL HTN-2 clinical trial
The first patient was treated in the CONTROL hypertension (HTN)-2 clinical study, the Rox Medical’s pivotal study to evaluate the safety and effectiveness of...
Medtronic launches Concerto 3D detachable coil system in USA and Europe
Medtronic is expanding its embolisation product portfolio with the launch of the Concerto 3D detachable coil system. The system was launched at the Cardiovascular...
Lesion preparation using Diamondback 360 orbital atherectomy enhances paclitaxel distribution in calcified peripheral arteries
CBSET, a not-for-profit preclinical research institute dedicated to translational research, education, and advancement of medical technologies, has announced that its scientists have published data...
Vasorum launches Celt ACD second generation vascular closure device in the USA
Following FDA approval of its PMA supplement, Vasorum has added a 7F Celt ACD vascular closure device to its Celt ACD 6F and Celt...
IN.PACT Admiral drug-coated balloon is approved in Japan
Medtronic announced on 8 September 2017 that the IN.PACT Admiral drug-coated balloon (DCB) received approval from the Japanese Ministry of Health, Labour and Welfare...
RD Global-Invamed receives CE mark to market Extender DCB and Temren atherectomy with CTO...
RD Global-Invamed has announced it has received CE marking to market the Extender drug-coated balloon (DCB) and Temren atherectomy with CTO catheter for treating...
Registry shows better patency and fewer reinterventions for Aperto drug-coated balloon in the treatment...
Drug-coated balloon treatment for vascular access stenosis offers a real alternative to plain balloon angioplasty, reducing the rate of reinterventions and prolonging the lifespan of...
First four Spanish VasQ cases completed
Laminate Medical has announced the success of the first four Spanish clinical cases using the VasQ device.
The cases were performed by Gaspar Mestres at...
Essential Medical marks first 1,000 Manta cases and expands production capacity
Essential Medical has announced that more than 1,000 Manta large bore vascular closure devices have been successfully deployed globally. To meet the growing demands...
Maarit Venermo
Maarit Venermo was driven to a life in medicine by her competitive nature and arrived at medical school with little idea of what speciality...
First commercial use of Ra Medical Systems’ DABRA takes place in USA
The Heart Endovascular & Rhythm of Texas announced its latest collaboration with Ra Medical Systems to use the Destruction of Arteriosclerotic Blockages by laser...
Lutonix for dysfunctional arteriovenous fistulae shows improved primary patency vs. plain balloon angioplasty at...
Interim twelve-month data from the Lutonix AV Clinical Trial indicate that treatment of dysfunctional arteriovenous (AV) fistulae with Bard’s Lutonix drug-coated balloon (DCB) produces...
First patients enrolled in Mercator MedSystems TANGO trial
Mercator MedSystems has announced the first patient enrolment into the TANGO (Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee) clinical trial. TANGO...
CX audience homes in on grey area between drug-coated balloons and stents
At the 2017 Charing Cross Symposium (CX; 25–28 April, London, UK), delegates heard brand new data for drug-coated balloons (DCBs) in “wider use” scenarios...
Humacyte’s Humacyl receives US FDA expedited review designation
The US Food and Drug Administration (FDA) has granted Humacyte’s Humacyl investigational human acellular vessel (HAV) Regenerative Medicine Advanced Therapy (RMAT) designation.
This designation means...
Tigris stent gets Health Canada approval for peripheral artery disease
Gore has announced the Health Canada approval of the Tigris vascular stent, a dual-component stent with a unique fluoropolymer/nitinol design. The device, which gained...
Percutaneous bypass using femoral vein could be “an important step” in treatment of long...
In a first-time data release, Dierk Scheinert presented six-month outcomes from the DETOUR trial of percutaneous bypass in long segment femoropopliteal occlusions at the...
North Dallas Research Associates begin enrolling TOBA II BTK patients
North Dallas Research Associates, Dallas, Texas, and its private practice, Cardiac Center of Texas, have announced their participation in the Tack Optimized Balloon Angioplasty II...
Cagent Vascular announces FDA 510(k) clearance of Serranator Alto serration balloon catheter
Cagent Vascular has announced US Food and Drug Administration 510(k) clearance of its lead product, the Serranator Alto percutaneous transluminal angioplasty serration balloon catheter. The Serranator...
The success of deep venous intervention rests on mid- to long-term outcomes
In this interview, Vascular News speaks to Prakash Saha, King’s College Hospital, London, UK, about the growth of deep venous treatment and how the...
Achieving haemostasis in radial artery access
The VasoStat (Forge Medical) is a haemostasis device designed for radial, brachial and transpedal procedures. The device is placed over the puncture site to...
Tack endovascular system secures CE mark for repair of dissections following below-the-knee angioplasty
Intact Vascular has attained the CE mark for the Tack endovascular system for the repair of arterial dissections following percutaneous transluminal angioplasty (PTA) below...
US trial of Essential Medical’s MANTA device begins
Essential Medical has announced the start of the Manta vascular closure device US pivotal trial.
The first US case was performed on November 28 by...
Akesys and Elixir announce first human implant of the Prava bioresorbable scaffold
Akesys Medical has announced their first clinical trial and successful implant of the Prava sirolimus-eluting bioresorbable peripheral scaffold system for the treatment of blockage...
Avinger granted expanded US FDA indications for Pantheris image-guided atherectomy device
Avinger has received expanded indications from the US Food and Drug Administration (FDA) recognising the Pantheris lumivascular atherectomy system as a technology that can be...
The use of robotics in peripheral artery disease interventions
Despite significant advances in pharmacotherapy and device technology for percutaneous cardiovascular interventions, the fundamental technique of manually advancing intravascular devices at the patient’s table...
Lymphoedema management: A collaborative approach for patients and clinicians
Lymphoedema is a chronic, progressive condition which can often be debilitating. It is caused by a deficiency or failure of the lymphatic system. Due...
Shockwave Medical Lithoplasty system is cleared by the FDA
Shockwave Medica has announced clearance from the US Food and Drug Administration (FDA) of the Lithoplasty system for the treatment of calcified plaque in...
First patient enrolled in the MIMICS-3D registry
Veryan Medical has announced that the first patient has been enrolled into the company-sponsored MIMICS-3D registry by Michael Lichtenberg, Arnsberg, Germany. MIMICS-3D is a...
Essential Medical announces closing on US$14.9 million series B funding
Essential Medical has announced that it has completed a series B financing of US$14.9 million. The round was led by Amzak Health along with...
CE mark granted to InSeal Medical for InClosure vascular closure device
InSeal Medical has received CE mark approval for its InClosure VCD; a large bore vascular closure device. According to a press release, the InClosure...
Gore Tigris vascular stent gains FDA approval for treatment of peripheral artery disease
Gore has announced US Food and Drug Administration (FDA) approval of the Gore Tigris vascular stent, a dual-component stent with a unique fluoropolymer/nitinol design....
REALITY trial enrols first patient in study evaluating Medtronic directional atherectomy and DCB
Medtronic and VIVA Physicians reported on 27 July 2016 the first patient enrolled in the REALITY Study. The VIVA-sponsored study is assessing outcomes for...
Vasorum receives premarket FDA approval for Celt ACD vascular closure device
Vasorum has received approval of its premarket approval application from the US Food and Drug Administration (FDA). Celt ACD, which has received CE mark and...
CE mark granted to Essential Medical’s Manta device
Essential Medical has received CE mark approval for Manta, the company's large bore vascular closure device.
Nicolas Van Mieghem, principal investigator in the EU study...
Essential Medical announces FDA approval to begin US trial for the Manta large bore...
Essential Medical announced on 8 July 2016 that it has received investigational device exemption (IDE) approval from the FDA to begin the US clinical...
Enrolment commences for Intact Vascular’s TOBA III trial
Intact Vascular has announced that its Tack Optimised Balloon Angioplasty III (TOBA III) clinical trial has commenced enrolment, with the first patient treated by...
Good day for drug-coated balloons, swirling flow stents and drug-eluting stents at CX 2016
The CX Peripheral Arterial Challenges session at the 2016 Charing Cross Symposium (CX 2016; 25–29 April, London, UK) saw a host of new developments...
Carbon dioxide flushing of stent grafts may help reduce air embolisation during TEVAR
A study published in the Journal of Endovascular Therapy suggests that carbon dioxide flushing may be a solution for the “potentially underappreciated” problem of...
When to use intervention for deep venous thrombosis and pulmonary embolism
At the 2016 Leipzig Interventional Course meeting (LINC; 26–29 January, Leipzig, Germany), Michael R Jaff, Boston, USA, discussed the challenges facing intervention for deep...
Avinger announces FDA clearance and US launch of enhanced Pantheris system
Avinger has received 510(k) clearance from the US Food and Drug Administration (FDA) for an enhanced version of its Pantheris lumivascular atherectomy system, an...
ArtVentive announce enrolment in OCCLUDE post-market study of the EOS embolisation device
ArtVentive Medical has announced enrolment in the ongoing OCCLUDE post-market surveillance study. This study aims to further the use of the EOS endoluminal occlusion...
Edoxaban with aspirin may be a “paradigm shifting” treatment for peripheral artery disease patients...
Peripheral artery disease patients who undergo endovascular treatment may have a lower risk of major and life-threatening bleeding events and a lower risk or...
In the spotlight: Atherectomy
The removal of plaque from peripheral arterial lesions is often needed when preparing vessels for adjunct therapies such as drug-coated balloons and drug-eluting stents....
Essential Medical completes enrolment of EU clinical studies for Manta large bore vascular closure...
Essential Medical has completed enrolment of its European CE mark clinical study of Manta, the company’s large bore vascular closure device.
Preliminary results from the...
Intact Vascular presents positive data from TOBA-BTK study at LINC 2016
Positive six-month results from Intact Vascular’s TOBA-BTK (Tack Optimised Balloon Angioplasty—Below-the-Knee) clinical study have been reported at LINC 2016. The data were presented by...
Intact Vascular presents positive data from TOBA-BTK study at LINC 2016
Positive six-month results from Intact Vascular’s TOBA-BTK (Tack Optimised Balloon Angioplasty—Below-the-Knee) clinical study have been reported at LINC 2016. The data were presented by...
NuCryo Vascular receives 510(k) clearance for PolarCath reusable cryoplasty inflation device
NuCryo Vascular has received 510(k) clearance for its reusable cryoplasty inflation device. NuCryo will be selling the current and next generation model via a...
Supera stent offers effective cost-saving peripheral artery disease treatment for both payer and provider
The Supera peripheral stent offers the lowest risk of repeat procedures and is an “economically attractive” treatment for both payer and provider, according to...
First VasQ cases completed in Germany
Laminate Medical Technologies has announced the success of the first two German clinical cases using VasQ—an external support device for arteriovenous fistulas implanted during...
Drug-coated balloons can be a valid tool in the treatment of renal in-stent restenosis...
Following the positive results obtained by drug-coated balloon in the peripheral arterial disease, many operators have started to extend the indications of these devices...
GAIA-DEB: Drug-coated balloon before biodegradable scaffold does not prevent restenosis
Results from the GAIA-DEB study published online ahead of print in the Journal of Endovascular Therapy show no sustained benefit of dilation with a...
ArtVentive Medical begins testing the next generation of its EOS Technology
ArtVentive Medical has conducted the first animal study of its next generation of the ArtVentive Endoluminal Occlusion System (EOS Gen II). The EOS is...
We “still await” the ideal venous stent, despite rapid development in technology
By Athanasios D Giannoukas
Today, venous stenting plays an important role in the treatment of deep venous pathologies. The current indications for its use include acute...
Spiral laminar flow is the predominant flow pattern in 97% of patients in observational...
Vascular Flow Technologies has presented data showing that spiral laminar flow is the predominant flow pattern in arteries.
The “Spiral laminar flow in arteries” study...
Cardiovascular Systems enrols first patients in OPTIMIZE study
The first two patients have been enrolled in Cardiovascular Systems’ OPTIMIZE peripheral orbital atherectomy system study. Taking place in Europe, OPTIMIZE will evaluate the...
IN.PACT SFA two-year results “have potential to drive paradigm shift” in femoropopliteal lesion treatment
Two-year results of the IN.PACT SFA randomised controlled trial demonstrate durability and continued superiority of the IN.PACT Admiral drug-coated balloon (Medtronic) over plain balloon...
Intact Vascular announces conditional FDA approval for TOBA II study and enrolment of first...
The US Food and Drug Administration has granted conditional approval for a US and European Investigational Device Exemption (IDE) clinical trial to investigate the...
Visceral and renal aneurysms: When and how to occlude or preserve
By Rabih A Chaer
Visceral artery aneurysms are rare with an incidence as low as 0.1–2% in the general population. Though the morbidity and mortality...
CMS grants new technology add-on payment for inpatient use of Medtronic’s drug-coated balloon
The decision will provide patients with additional access to the IN.PACT Admiral drug-coated balloon with the potential to improve the standard of care for peripheral arterial disease in vessels above the knee.
CMS approves add-on payment for Lutonix drug-coated balloon for inpatient use
The purpose of the reimbursement is to help cover additional cost to US hospitals for treating Medicare beneficiaries with Lutonix in the inpatient setting.
Eximo Medical announces completion of its series A round and plans for first in...
The company's Cathi hybrid catheter is to be used in a safety and efficacy peripheral atherectomy study planned for Q4 2015. According to Eximo, the technology has the potential to optimise safety and performance expected to reduce the risk of vessel perforation.
Essential Medical commences EU studies for Manta large bore vascular closure device
Initial patients in the study were enrolled in Rotterdam, the Netherlands, and Milan, Italy, where Manta 18F devices were successfully deployed achieving immediate haemostasis following transcatheter aortic valve replacement.
Selective use of embolic protection devices should be considered for complex superficial femoral artery...
At SITE, Gustavo S Oderich said that there are no definitive studies supporting routine use of embolic protection devices in superficial femoral artery interventions. However, he stated that these devices prevent embolisation during complex procedures.
FDA clears guidewire for Cardiovascular Systems’ peripheral orbital atherectomy systems
According to the company, the ViperWire advance peripheral guidewire with flex tip offers greater flexibility and navigation; improves systems' ease-of-use when treating calcified lesions in torturous arterial anatomy.
Medtronic announces financial investment in Arsenal AAA
In return for the investment, Medtronic has received an option to acquire Arsenal AAA after the company achieves certain milestones. Financial terms of the investment were not disclosed.
CMS approves removal of offset charge associated with pass-through payment for DCBs in the...
With the offset charge removal, the full cost of peripheral drug-coated balloons will be reimbursed under the Medicare outpatient prospective payment system.
IN.PACT Admiral shows positive results in long lesions at one year
Presented for the first time at EuroPCR 2015, new clinical data from two different studies show that the IN.PACT Admiral drug-coated balloon successfully treated long lesions in the superficial femoral and popliteal arteries.
NuVascular forms business advisory board
Executives from technology and energy sectors join effort to develop next generation of nanotechnology.
Intact Vascular’s Tack system first-in-man results published
Early experimental and clinical experience with the Tack endovascular system for lower extremity post-angioplasty dissection suggests a safe and feasible alternative treatment.
CE mark for Magellan10F robotic catheter
Hansen Medical has announced that the company's Magellan 10F robotic catheter has received the CE mark for use in the peripheral vasculature.
EverFlex peripheral stent delivers sustained patency in long, complex lesions
Medtronic's EverFlex is a nitinol stent system that expands to a predetermined diameter to re-open stenotic regions of the superficial femoral artery and proximal popliteal arteries that supply blood to the legs.
Vascular Solutions launches PolarCath Peripheral Dilatation System
The PolarCath peripheral dilatation system is indicated for use in dilating stenoses in the peripheral vasculature and for the treatment of obstructive lesions of PTFE access grafts or arteriovenous dialysis fistulae.
OCT imaging after carotid artery stenting reveals microdefects related to device design
A study published in the European Journal of Vascular and Endovascular Surgery shows that in the carotid arteries, stent malapposition is more frequent with closed-cell stents while plaque prolapse is more common with open-cell stents.
Medicare approves pass-through payment for Lutonix drug-coated balloon for outpatient use
The purpose of the supplemental reimbursement is to cover additional cost to US hospitals for treating Medicare beneficiaries with Lutonix in the outpatient setting.
White matter damage is associated with poor outcome in vascular surgery claudicant patients
The results of the BAROSLEEP study, published in EJVES, show that microstructural white matter damage is associated with poor outcome in patients with claudication requiring surgical revascularisation. Timo Laitio spoke to Vascular News about the study and its clinical implications.
The IN.PACT DEEP trial: Putting the results into context
By Krishna Rocha-Singh
How can we account for the lack of treatment effect of the IN.PACT Amphirion below-the-knee drug-eluting balloon (Medtronic) versus standard percutaneous transluminal...
IN.PACT Admiral drug-eluting balloon receives FDA approval
In the IN.PACT SFA trial, the device demonstrated the lowest clinically-driven target lesion revascularisation rate (2.4%) ever reported for an interventional treatment of peripheral arterial disease in the superficial femoral artery.
Gunnar Tepe
Gunnar Tepe, professor of Radiology, Department of Diagnostic and Interventional Radiology, Klinikum Rosenheim, Rosenheim, Germany, was involved in the development of the first drug-coated...
Cardionovum begins clinical study of Aperto drug-coated balloon
Cardionovum has initiated a 150-patient clinical study of its novel paclitaxel-releasing, high-pressure shunt balloon dilatation catheter, Aperto.
Early results suggest Lithoplasty may be effective in the treatment of calcified peripheral lesions
Results of the DISRUPT PAD study show that Lithoplasty, a new balloon-based technology, demonstrates safety and efficacy in the treatment of superficial femoral artery and popliteal artery disease.
Veniti announces first US patients enrolled in VIRTUS trial
Veniti has enrolled the first US patients in the VIRTUS trial of the Venti Vici venous stent system, with four procedures performed at two sites.
First drug-eluting balloon approved in USA
The FDA has approved the Lutonix drug-eluting balloon for the management of peripheral artery disease. This is the first time that the agency has approved such a device for this indication in the USA.
Rotarex S and Aspirex S endovascular catheters approved in Brazil
These endovascular rotational catheters from Straub Medical restore blood flow in occluded blood vessels by removing occlusion material from the vessel.
First European patients enrolled in QT Vascular’s ENDURE trial
QT Vascular has announced that it has enrolled the first European patients in the ENDURE trial in Germany. Multiple patients have already been enrolled in this study by Andrew Holden, Auckland, New Zealand.
Mechanical blood clot removal system helps clean up patient’s leg
Andre Bouhasin, an interventional cardiologist with West County Heart and Vascular Diagnostics, St Louis, Missouri, USA, used a novel device to remove blood clots and emboli from a protective filter and native arteries to restore blood flow in a patient's leg.
DEFINITIVE LE study results show directional atherectomy is safe and effective in claudication and...
The multicentre, 800-patient study also demonstrated that directional atherectomy was non-inferior for treating peripheral arterial disease in patients with diabetes compared with those without diabetes.
Avinger enrols first patient in VISION trial
VISION is a global investigational device exemption (IDE) clinical trial, approved by the FDA, to evaluate Avinger's Pantheris catheter for the treatment of peripheral artery disease.
Ultrasound-enhanced delivery of paclitaxel inhibits restenosis after balloon angioplasty
Results from a feasibility study conducted in Italy indicate that ultrasound-enhanced paclitaxel delivery inhibits arterial smooth muscle proliferation after balloon angioplasty in peripheral arterial disease.
Covidien releases two-year results demonstrating sustained effectiveness of drug-coated angioplasty balloon technology
Covidien's Stellarex drug-coated angioplasty balloon continues to be shown as safe and effective for treatment of peripheral arterial disease, according to new 24-month data released from the company's ILLUMENATE first-in-human study.
First patients enrolled in a clinical study of drug-coated Chocolate balloon
TriReme Medical announced that the first three patients were enrolled in a clinical study of its unique drug-coated Chocolate percutaneous transluminal angioplasty balloon. Andrew Holden, co-principal investigator of the study, performed these procedures at Auckland City Hospital, in Auckland, New Zealand.
Andrew Holden
Andrew Holden, associate professor of Radiology, Auckland University School of Medicine, Auckland, New Zealand, has been involved in the investigation of several endovascular devices...
Interim outcomes in Chocolate balloon angioplasty registry demonstrate high rates of procedural success and...
The TriReme Medical Chocolate percutaneous transluminal angioplasty balloon achieved high rates of treatment success and limb preservation in patients with peripheral arterial disease.
Boston Scientific launches OffRoad re-entry catheter system
Boston scientific has launched the OffRoad re-entry catheter system, which provides physicians with a new option for treating complete blockages in the major arteries of the leg.
It is time to restate the vascular surgical principles of lower limb revascularisation
Proximal before distal and techniques for one level do not necessarily apply to another. I am reminded of these principles in the article reporting...
Passeo-18 Lux drug-eluting balloon released in Europe
Six- and 12-month data from the BIOLUX P-I study showed that patients treated with Passeo-18 Lux were less likely to require reintervention than those treated with plain balloon angioplasty.
IN.PACT Amphirion drug-eluting balloon recalled after negative results below the knee
The first presentation of data from IN.PACT DEEP clinical study will occur at LINC; none of Medtronic's other drug-eluting balloons or peripheral products are affected.
Catheter-directed prostaglandins effective in the treatment of critical limb ischaemia
By Marcelo Pataro, Marcelo Dándolo, Juan Chica and Oscar Ojeda
Prostaglandins are unsaturated fatty acids that are produced by the metabolism of phospholipids of the...
Therapy with GM-CSF fails to improve walking ability for patients with peripheral artery disease
In a study presented at the AHA Scientific Sessions and published online in JAMA, researchers have found that therapy with granulocyte-macrophage colony stimulating factor (GM-CSF) did not improve treadmill walking time at three months of follow-up.
MIMICS data suggest patency protective effect with BioMimics 3D stent
Data presented at a late breaking clinical trials session at VIVA13 show that the 3D helical geometry of the BioMimics stent has demonstrated safety and promising clinical performance at 12 months in patients with femoropopliteal lesions.
Balloon with microneedle creates drug-eluting reservoir to prevent restenosis
Patrice Bergeron, Marseille, France, presented initial results of a new device used in the treatment of peripheral arterial disease at the MEET Congress. The new balloon deploys a microneedle into the adventitia and diffuses anti-inflammatory drug into the arterial wall.
Avinger receives the CE mark for Pantheris lumectomy system
The Pantheris system combines directional atherectomy capabilities with real-time intravascular visualisation to remove plaque from blocked arteries. The system is designed to remove the blockage while avoiding the disruption of normal arterial wall structures.
Abbott completes acquisition of IDEV Technologies
The acquisition expands Abbott's global peripheral technology portfolio with IDEV Technologies' Supera Veritas self-expanding nitinol stent system, which has the CE mark for treating peripheral arterial disease.
Harvard researchers create vascular endothelial cells
Using a unique approach, the researchers induced the differentiation of specific cell types by generating mechanical forces on the surface of the iPSC-derived endothelium mimicking the flow of blood.
First premarket approval module for In.pact Admiral drug-eluting balloon submitted to the FDA
The ongoing global clinical programme of In.pact drug-eluting balloons for the treatment of peripheral artery disease in the lower extremities includes 24 studies involving more than 4,200 patients at approximately 230 sites worldwide.
Medtronic reaches major milestone in clinical programme for In.pact Admiral drug-eluting balloon
Medtronic also announced that it plans to submit the first module of the pre-market approval application for the In.pact Admiral drug-eluting balloon to the FDA over the summer.
Flow diversion is a game changer
After listening to data for flow diverts, the majority of CX delegates voted yes to the question "Is intracranial flow diversion a game changer?"
Embolic capture angioplasty balloon an effective tool for avoiding embolic events in long peripheral...
Thomas Zeller, Bad Krozingen, Germany, and colleagues, reported their initial experience with the Proteus embolic capture angioplasty balloon for peripheral vascular disease in 15 patients in the Journal of Endovascular Therapy.
Real PTX study will compare drug-eluting stent and drug-eluting balloon in femoropopliteal lesions
At the LINC congress, Dierk Scheinert presented the details of a randomised trial that will evaluate the Zilver PTX drug-eluting stent vs. paclitaxel-eluting balloons in symptomatic femoropopliteal artery disease.
Sanofi announces commercial launch of LeGoo at the Society of Thoracic Surgeons meeting
As the first atraumatic intraluminal occlusion gel, LeGoo is injected into a blood vessel and forms a plug that molds to the shape of the vessel, stopping blood flow temporarily.
Is fractional flow reserve applicable to peripheral arteries as well as coronaries?
By Christopher K Zarins
The primary objective of treating an arterial stenosis is to improve blood flow. But how do we determine whether a lesion needs...
Medtronic drug-eluting balloon study completes enrolment
The IN.PACT SFA II trial enrolled 181 patients at more than 40 US sites and randomised them 2:1 to the IN.PACT Admiral drug-eluting balloon or a non-coated angioplasty balloon.
CSI presents late-breaking data at ISET 2013
CSI's minimally invasive Orbital Atherectomy technology protects healthy vessel tissue while removing even the most difficult-to-treat plaque throughout the leg with fewer complications.
STROLL trial two-year results highlight durability of clinical outcomes with S.M.A.R.T. stent
The STROLL study assessed the safety and efficacy of the S.M.A.R.T. Vascular Stent Systems in treating patients with obstructive superficial femoral artery disease.
Stem cells found to heal damaged artery in lab study; raises hope for developing...
Scientists at the Texas Biomedical Research Institute have for the first time demonstrated that baboon embryonic stem cells can be programmed to completely restore a severely damaged artery.
Covidien completes enrolment in the DEFINITIVE AR study
This new clinical study addresses restenosis prevention in patients with peripheral arterial disease.
Covidien to acquire drug-eluting balloon company
CV Ingenuity's core technology, while still in the investigational phase, is a drug-eluting balloon platform with a novel, proprietary, tunable, rapid-release system.
How we perform distal bypasses in TASC D lesions
By Roberto Sacilotto
In the past decade, the most significant change in the treatment of critical limb ischaemia has been the shift from bypass surgery...
True Human monoclonal antibody may help to reduce restenosis after percutaneous revascularisation of the...
Results from a phase II study in patients who underwent percutaneous revascularisation of the superficial femoral artery and received the IL-1a True Human monoclonal antibody (MABp1, XBiotech) have shown a 58% reduction in major adverse cardiovascular events and 60% longer patency in treated vessels compared to control patients.
BioMimics 3D Stent gets the CE mark for the treatment of superficial femoral and...
The CE mark approval was based on results from the MIMICS study which demonstrated the BioMimics 3D Stent is safe and showed positive clinical outcomes at both six and 12 months.
Gore Hybrid Vascular Graft available in 10cm configuration
The new configuration of this vascular graft used for replacement or bypass of diseased vessels, allows physicians to access even deeper vessels and create new access sites in anatomical locations that would have otherwise been abandoned.
Penetrating trauma in the endovascular era
By Roberto Chiesa
The dawn of modern vascular traumatology dates back to World War II and is associated with two important aspects: the use of...
Supera stent shows positive patency outcomes in SUPERB trial
"In the SUPERB trial, the Supera stent achieved one-year patency rates not previously achieved in a pivotal trial for any stent placed in the superficial femoral artery (SFA) and proximal popliteal artery," said Kenneth Rosenfield, co-principal investigator of the trial at VIVA 2012.
Spectranetics announces US launch of Tapas catheter at VIVA
The Tapas catheter features a drug infusion system allowing treatment of long peripheral vascular segments with only one device.
Is this a setback for drug-eluting balloons?
Vascular News has learned from industry sources at the CIRSE annual meeting that Bayer HealthCare is looking into discontinuing the production of the Cotavance drug-eluting balloon using the Paccocath technology.
The role of genetic testing in aortic disease
By James H Black III
Patients with connective tissue disorders have benefitted tremendously from the advent of modern molecular biology research including mapping of the...
Promus Element Plus drug-eluting stent launched in Europe for treatment of severe lesions below...
The Promus Element Plus BTK is indicated for the treatment of critical limb ischaemia or severe lower leg claudication in infrapopliteal lesions.
Can a new generation peripheral stent minimise thrombotic risk?
By Anna Maria Ierardi and Gianpaolo Carrafielo
Endovascular treatment for atherosclerotic obstructions in femoropopliteal arteries is widely used for patients with intermittent claudication and critical...
Intact Vascular gets CE mark approval for Tack-it Endovascular Stapler device
The Tack-it Endovascular Stapler device is designed to optimise peripheral angioplasty results for the treatment of peripheral artery disease.
Charles McCollum
Charles McCollum, University of Manchester, UK, became consultant and senior lecturer in Surgery at the Charing Cross Hospital, London, UK, in 1983, aged 32....
Lower restenosis and re-occlusion rates with drug-eluting balloons in DEBATE-BTK
The preliminary results of the study show that a paclitaxel-eluting balloon seems to provide better results in terms of 12-month restenosis and re-occlusion below the knee compared to conventional balloon angioplasty.
Infant acute limb ischaemia should be treated non-operatively
Children with acute limb ischaemia should be treated conservatively with observation and anticoagulation, and intervention should be performed only in cases presenting tissue loss, a study presented by Jesus M Matos at the Society for Vascular Surgery Annual Meeting has recommended.
Overview of vascular imaging modalities
Vascular speciaslists speak about the use of imaging in carotid, venous, thoracic, abdominal aortic aneurysm and lower limb interventions.
What have we learned from stem cell and gene therapy trials in the periphery?
For angiogenic gene therapy, mixed results in phase I/II trials were followed by a negative result in a very large phase III trial (TAMARIS), Sigrid Nikol, Asklepios Klinik St Georg, Hamburg, Germany, will tell delegates at CX 33.
Setback for gene therapy in TAMARIS
Although earlier trials were promising, the TAMARIS trial showed that an experimental gene therapy growth factor failed to prevent death or amputations in patients with severely blocked lower limb blood vessels. Sigrid Nikol, Asklepios Klinik St Georg, Hamburg, Germany, explains to VascularNews.com the negative results of TAMARIS.
What is the evidence that tibial angioplasty works?
Peter Schneider told delegates at the Society for Vascular Surgery (SVS) Annual Meeting, in Boston, that tibial artery angioplasty has benefits when compared with...
Zenith Low Profile AAA Endovascular Graft receives CE mark
Click on story to view video demonstration.
Cordis launches ExoSeal vascular closure device
New trial results on ExoSeal Vascular Closure Device support its clinical safety and efficacy. Device was lauched during EuroPCR in May 2010.
Cutting balloons no better than conventional angioplasty
Erich Minar, Medical University Vienna, Austria, reviewed the effectiveness of cutting balloon angioplasty at the TCT conference, in San Francisco, USA.
Invatec announces launch of REEF HP PTA balloon catheter in Europe at CIRSE 2009
New catheter specifically designed for AV shunts and hard-to-dilate peripheral lesions
Zilver PTX drug-eluting stent from Cook Medical could greatly reduce need for leg amputations...
World's first drug-eluting stent for a widespread form of peripheral arterial disease now available throughout the EU.
Endovascular repair must go 3D
3D computed tomography can now overcome the limited accuracy of conventional angiography in measuring complex anatomy, says Florian Dick
Endpoints
Nicolas Diehm says uniform endpoint definitions are mandatory to grant comparability of future endovascular studies
Endovascular therapy for the treatment of peripheral arterial occlusive disease...
Seaweed and fireflies guide stem cell treatment for peripheral artery disease
Successful delivery of live, traceable stem cells for reconstitution of blood vessels is demonstrated in animal model
New exhibitors at CX 31
Every year, new exhibitors see the CX Symposium as an excellent opportunity to showcase their products and services to an internationalaudience of medical professionals.
New products at CX 31
A range of new products for the treatment of vascular disease will be launched and showcased at the CX Symposium. Aorfix (Lombard), Lifestent (Bard), Viabahn (Gore), IN.PACT (Invatec), and VenaCure EVLT (Angiodynamics) are some of the innovations available in the industry area.
Multilayered stent heralds “paradigm shift”
Investigational study presented at the International Congress on Endovascular Interventions shows promise for revolutionary stent
Promising results of Pathway for atherectomy device
Dr William A Gray presented the conclusions of the peripheral arterial disease intervention with the Pathway Medical Atherectomy System at the ISET 2009 meeting.
CX Innovation Showcase: Window on new technologies
New technologies get an airing at this year's Charing Cross International Symposium
Positive results for sirolimus-eluting stents in treating CLI
Dr. Konstantinos Katsanos, presented study at the recent EuroPCR meeting in Barcelona held from May 22-25 2007.
CryoPlasty provides a ‘valuable alternative’ to amputation
David Kessel, at the 2007 Charing cross meeting in London.
Boost for stenting in the SFA
The results from three studies revealed that stenting is a safe and effective treatment option for treating SFA lesions
Protege RX carotid stent approved in the US
The Prot©g© RX Carotid Stent has an innovative delivery system that allows physicians to place the stent accurately and also provides great visible confirmation due to its distinct radiopaque markers.
Angioblasts may stimulate vascular regeneration
Interest generated in the use of angioblasts for neovascularization of ischemic or injured tissue
New visualization system for PAD patients
The new system combines real-time imaging with the company's FDA-cleared SilverHawk Plaque Excision system.
EMPiRE study to assess GORE Neuro Protection System
..."The GORE Neuro Protection System is an important advancement in protecting patients during carotid artery stenting procedures"
Atherectomy devices in new trials
First patient has been enrolled in the CELLO (CliRpath Excimer Laser System to Enlarge Lumen Openings) trial
SilverHawk to start multi-center clinical trial
FoxHollow Technologies' SilverHawk plaque excision system
The art of clotbusting
Clot Lysis and Thrombolytic Therapy
CX consensus 2005 and TASC 2006
Recommendations compared
Hybrid treatment for acute Type A dissection “safe and feasible” for high-risk patients
The role of hybrid procedures for acute type A dissection
ev3 reveals 30-day carotid results
The Preliminary 30-day results from the Phase I CREATE trial
Clinical trial updates at Charing Cross
Including SIROCCO II, ASTRAL, MAVEric, SAPPHIRE and MIMIC
Charing Cross goes from strength to strength
Last year's Charing Cross International Symposium reached new heights
Gene therapy could replace amputation
ISET celebrates 15 years of innovation in education
Beyond drug-eluting stents
What happens when the drug is gone?
Laser best in the long-term
Study on endovenous laser therapy treatment for varicose veins
