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REALITY study “sets new benchmark” for assessment of claudicants with severe femoropopliteal disease
Krishna Rocha-Singh (Springfield, USA) speaks to Vascular News about his presentation at VIVA20 (Vascular Interventional Advances; 6–7 November 2020; virtual) on the REALITY study,...
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...
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.
New analysis: Four multicentre trials support primary use of DCBs over bare metal stents...
A patient-level, propensity-adjusted comparison of three-year results from a quartet of prospective, multicentre trials support the primary use of drug-coated balloons (DCBs) versus bare...
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...
Latest meta-analysis on paclitaxel in peripheral arterial disease provokes mixed reception
“There appears to be heightened risk of major amputation after use of paclitaxel-coated balloons in the peripheral arteries,” findings from a systematic review...
Femoropopliteal bypass shows reintervention benefit over endovascular therapy for advanced premature PAD
Femoropopliteal bypass is associated with decreased reinterventions at one year compared to endovascular therapy in patients with advanced premature peripheral arterial disease (PAD). This...
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...
Real-world analysis demonstrates lower long-term mortality after DCB angioplasty of femoropopliteal lesions
In a real-world retrospective analysis, recently published in JACC: Cardiovascular Interventions, the long-term mortality rate was lower after drug-coated balloon (DCB) angioplasty than after plain...
BD announces publication of drug-coated balloon safety data for femoropopliteal PAD
BD has announced the publication of a company-initiated, independent analysis of the Lutonix 035 drug-coated balloon (DCB) femoropopliteal clinical programme in the Journal of...
New JAMA analysis with short follow-up finds “an association of survival” with drug-coated device...
A recent US-wide, multicentre analysis has found no evidence of increased all-cause mortality associated with the use of paclitaxel-coated devices compared with non-drug-coated devices...
IN.PACT SFA five-year outcomes show sustained benefits of drug-coated balloon in femoropopliteal lesions
The IN.PACT SFA trial’s co-principal investigator John Laird, from the Adventist Heart and Vascular Institute in St. Helena, USA, has presented the five-year outcomes...
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...
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...
PQ Bypass reports positive results for Detour system in patients with long femoropopliteal blockages
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour system for treating long-segment (>25cm)...
Outpatient atherectomy outcomes may be “worse than natural history of disease”
Atherectomy for occlusive disease in the femoral-popliteal and tibial-peroneal segments for claudication in outpatient settings may result in outcomes worse than the natural history...
Shockwave Medical announces plans for “largest ever” calcified peripheral artery disease study
Shockwave Medical has announced plans for DISRUPT PAD III—what is claims is the “largest ever” multicentre randomised study to exclusively enrol patients with calcified...
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...
One-year Japanese results support use of the Viabahn endoprosthesis to treat complex SFA disease
Gore has announced positive results from a prospective, multicentre investigational device exemption (IDE) clinical study of the Viabahn endoprosthesis with heparin bioactive surface in...
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...
New drug-coated balloons outperform plain angioplasty in the femoropopliteal artery at six and 12...
Performing angioplasty with new drug-coated balloons to treat femoropopliteal artery disease results in lower rates of late lumen loss and clinically-driven target lesion revascularisation compared with plain angioplasty at both six- and 12-month follow-up, according to new data.
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)...
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...
Biotronik Pulsar-18 self-expanding stent demonstrates efficacy in treating advanced superficial femoral artery disease
Investigator-initiated registry reveals 4 French interventions are effective and safe even for long, occluded femoropopliteal lesions.
Heparin-bonded endoprosthesis shows promising results in long femoropopliteal lesions
One-year results of the VIASTAR trial published online in the Journal of the American College of Cardiology suggest that a heparin-bonded covered stent may be superior to bare metal stents in the treatment of long femoropopliteal artery disease.
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.
FSS receives the CE mark for its new reconstrainable FlexStent femoropopliteal self-expanding stent system
The device is indicated for the femoropopliteal arteries; the system sizes include diameters of 5, 6, 7, and 8mm in lengths of 30 to 200mm with delivery system lengths of 80cm and 120cm.
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.
Zilver PTX receives FDA approval for the treatment of femoropopliteal lesions
For the first time, the FDA has approved a drug-eluting stent to treat blockages in a peripheral artery. In order to supply as many physicians as possible with this new technology, Cook said it is making Zilver PTX available initially in 80mm lengths in 6mm and 7mm diameters.
First US peripheral artery disease patient enrolled in CONNECT II trial
The CONNECT II global clinical trial is designed to evaluate the safety and efficacy of Ocelot (Avinger), the first-ever chronic total occlusion crossing catheter to use real-time intravascular optical coherence tomography imaging technology.
PATENT study shows positive results in treatment of in-stent restenosis in the femoropopliteal artery
Results from the PATENT (Photo-ablation using the Turbo-Booster and excimer laser for in-stent restenosis treatment) study presented at LINC 2012 in Leipzig, Germany, indicate 76% freedom from target lesion revascularisation at six months.
PEACE I All Comers registry results demonstrate efficacy of Pulsar-18 self-expanding stent
Along with earlier results from the 4EVER trial, PEACE I confirms the safety and efficacy of the Pulsar-18 stent with positive patency results, further establishing the benefits of 4 French intervention in treating even more advanced cases of femoropopliteal disease.
CX 2023 highlight: The BASIL-2 trial
Data and discussion on revascularisation treatment strategies for patients with chronic limb-threatening ischaemia (CLTI) will take centre stage at the CX 2023 Consensus update,...
IN.PACT Admiral DCB performs well across wide range of clinical and anatomical scenarios in...
In a pooled analysis of the predictors of drug-coated balloon (DCB) effectiveness, the IN.PACT Admiral DCB (Medtronic) performed well across a broad range of...
VIVA 2021: IN.PACT Admiral DCB found to provide “high five-year freedom from clinically-driven TLR”...
Real-world data drawn from the IN.PACT Global study looking at five-year freedom from clinically-driven target lesion revascularisation (TLR) among prespecified chronic total occlusion (CTO),...
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...
Case report: Recanalisation of a long SFA occlusion with Ultrascore™ Focused Force PTA Balloon...
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“Improving vessel compliance with focused force longitudinal plaque fracture seems to...
Concept Medical releases status updates on SIRONA RCT
Concept Medical has released a series of status updates on their head-to-head SIRONA (Sirolimus versus paclitaxel drug-eluting balloon angioplasty in femoropopliteal diseases) randomised controlled...
CX audience supports call to change agency recommendations regarding paclitaxel use in peripheral interventions
Addressing representatives from the US Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA) directly, Thomas Zeller (Bad Krozingen,...
Real data and experience for below-the-knee bypass back heparin-bonded ePTFE as “the best alternative...
In a Gore-sponsored satellite symposium at the 2021 Charing Cross (CX) Digital Edition (19–22 April, online), Richard Neville (Falls Church, USA) and Walter Dorigo...
Real data and experience for below-the-knee bypass back heparin-bonded ePTFE as “the best alternative...
In a Gore-sponsored satellite symposium at the 2021 Charing Cross (CX) Digital Edition (19–22 April, online), Richard Neville (Falls Church, USA) and Walter Dorigo...
CX audience supports call to change agency recommendations regarding paclitaxel use in peripheral interventions
Addressing representatives from the US Food and Drug Administration (FDA) and UK Medicines and Healthcare products Regulatory Agency (MHRA) directly, Thomas Zeller (Bad Krozingen,...
FDA Perspective in NEJM highlights need for continued clinical studies on paclitaxel devices
Following the publication of the SWEDEPAD interim analysis, Andrew Farb, Misti Malone, and William H Maisel, representatives of the Center for Devices and Radiological...
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...
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...
Flex Vessel Prep system receives new indication to address in-stent restenosis
VentureMed Group recently announced that the US Food and Drug Administration (FDA) cleared the company's Flex Vessel Prep system for use in the treatment...
PQ Bypass completes enrolment in DETOUR II pivotal study
PQ Bypass has announced enrolment of the final subject in the company’s DETOUR II investigational device exemption (IDE) clinical trial. This milestone occurs only...
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...
New prediction model for target lesion revascularisation grants “new level of security” to paclitaxel...
“Please feel free to utilise this in your practice,” Michael Dake (University of Arizona Health Sciences, Tucson, USA) urged on the first day of...
CMS grants additional reimbursement for the Eluvia drug-eluting vascular stent system
Boston Scientific announced that the US Centers for Medicare and Medicaid Services (CMS) granted a new technology add-on payment (NTAP) for the Eluvia drug-eluting...
Veryan Medical announces US launch and first commercial implant of BioMimics 3D vascular stent...
Veryan Medical recently announced the US launch and first commercial implant in the USA of the BioMimics 3D vascular stent system.
According to a press...
Hotly-contested meta-analysis suggests a higher risk of death or amputation at one year when...
A new meta-analysis, just published in the Journal of Vascular and Interventional Radiology (JVIR), suggests significantly worse amputation-free survival at one year with the...
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...
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...
Holden et al find no causal link between paclitaxel dose and all-cause mortality
The methodology underpinning the conclusion by Konstantinos Katsanos (Patras, Greece) et al that there is a positive dose-response relationship between paclitaxel and mortality is...
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...
SCAI supports continued use of paclitaxel-coated balloons
Experts from the Society for Cardiovascular Angiography and Interventions (SCAI) have reviewed the recent meta-analysis by Katsanos and colleagues and have concluded that the...
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...
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...
IVUS outperforms angiography in dissection detection post-PTA
The iDissection Classification trial results published in the Journal of Invasive Cardiology have shown that with the use of intravascular ultrasound (IVUS) investigators were...
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...
New CMS reimbursement code “severely underpays” for drug-coated balloons
Drug-coated balloon (DCB) angioplasty devices have been categorised by the US Centers for Medicare and Medicaid Services (CMS) into the same billing code as...
First patient treated in DETOUR II IDE trial
PQ Bypass has announced the enrolment of the first patients in the pivotal DETOUR II trial in the USA. The trial is a prospective,...
First data from head-to-head comparison of Ranger and IN.PACT drug-coated balloons presented at LINC
Early data from the first randomised controlled trial to compare two drug-coated balloons (DCBs) suggest that the primary patency obtained with the Ranger DCB...
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...
Spectranetics announces FDA approval of Stellarex drug-coated balloon
Spectranetics has announced receipt of US Food and Drug Administration (FDA) pre-market approval of the Stellarex drug-coated balloon (DCB), designed to restore and maintain blood flow...
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...
Leaving nothing behind: Is it time to move away from primary stenting in the...
This educational supplement is only available in countries in Europe.
This educational supplement explores the concept of “leaving nothing behind" in the treatment of the superficial...
Enrolment completed in the MIMICS-2 study
Veryan Medical has announced completion of patient enrolment in the MIMICS-2 clinical study of its BioMimics 3D self-expanding stent system (BioMimics 3D), which features...
Medtronic submits final data to FDA for In.Pact drug-coated balloon
The application includes data that demonstrates superior clinical outcomes compared with conventional angioplasty, with the lowest rates of repeat procedures (target lesion revascularisation) and the highest rate of uninterrupted blood flow (primary patency) at 12 months ever reported for the interventional treatment of peripheral artery disease.
How I treat the superficial femoral artery
The superficial femoral artery still represents one of the major challenges facing endovascular specialists. Dennis Gable, chief of Vascular Surgery, Heart Hospital Baylor Plano,...
Drug-eluting devices for the superficial femoral artery–why and when to treat?
While a large number of physicians are now convinced that drug elution represents a step forward from angioplasty and bare metal stenting in the...
Covidien completes enrolment in the DEFINITIVE AR study
This new clinical study addresses restenosis prevention in patients with peripheral arterial disease.
Clinical trial for Zilver PTX paclitaxel-eluting stent shows sustained patency after three years
Patients treated with the Zilver PTX paclitaxel-eluting stent (Cook Medical) have shown 70.7% primary patency in the superficial femoral artery at 36 months compared to 49.1% patency for patients with percutaneous transluminal angioplasty and provisional bare metal stent placement.
Randomised trial shows early benefit of Zilver PTX drug-eluting stent
The results of the ZILVER PTX study were presented as a late breaking trial by Michael Dake, Stanford University, at the Transcatheter Cardiovascular Therapeutics 2010 congress.
Drug-coated balloons continue to show early promise
Preliminary data for the Lutonix Moxy drug-coated balloon were presented at the Transcatheter Cardiovascular Therapeutics 2010 congress.
More vascular and endovascular controversies at Charing Cross
World class faculty of the leading endovascular and vascular specialists
BASIL-2 points towards endovascular-first revascularisation strategy in CLTI patients
A question from Manj Gohel (Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK) on what the Charing Cross (CX) audience should take back to...
AVS’ pulsatile IVL technology attracts an additional US$8.8 million to close US$28.8 million Series...
AVS, an early-stage medical device company focused on safely and effectively treating severely calcified arterial disease with its pulsatile intravascular lithotripsy (PIVL) therapy, has...
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...
Shockwave IVL: Preserving options in no-stent zones
This article forms part of an educational supplement sponsored by Shockwave Medical. Explore the full Compliance is Key series here.
Bella Huasen (Lancashire Teaching Hospitals...
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,...
Patients with claudication receive more “aggressive” surgical management in high-competition regions, study finds
Demonstrating the “susceptibility” of care delivery to regional market competition, M Libby Weaver (University of Virginia, Charlottesville, USA) presented the case that intermittent claudication...
The BeBack crossing catheter: A “game-changer” in endovascular PAD practice
This advertorial is sponsored by Bentley.
Crossing chronic total occlusion (CTO) lesions are challenging procedures. The BeBack crossing catheter—Bentley’s first product to be available in...
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...
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)...
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...
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...
Endologix submits premarket approval application to FDA for Detour system
Endologix has announced the submission of a premarket approval (PMA) application requesting approval for the Detour system to the US Food and Drug Administration...
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...
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...
BD launches first-in-human trial of a peripheral sirolimus drug-coated balloon
BD has announced the start of enrolment in a first-in-human trial of a peripheral sirolimus drug-coated balloon (DCB).
The PREVISION trial is a prospective, multicentre,...
New data on Biotronik’s Passeo-18 Lux DCB presented at LINC 2022
Biotronik recently announced the presentation of two studies on the performance of its drug-coated balloon (DCB) catheter Passeo-18 Lux at the Leipzig Interventional Course (LINC)...
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...
New long-term data of paclitaxel devices continue to show no increased mortality compared to...
New long-term data from the SAFE-PAD (Safety assessment of femoropopliteal endovascular treatment with paclitaxel-coated devices) study were presented today as late-breaking clinical research at...
Cardiovascular Systems announces first in-human experience with peripheral everolimus DCB
Cardiovascular Systems Inc (CSI) has announced the start of enrolment in a first in-human trial of the peripheral everolimus drug-coated balloon (DCB) being developed...
Vascular News’ top 10 most popular stories of February 2022
February's top 10 includes a consensus statement from the Society for Vascular Surgery (SVS) and the Enhanced Recovery after Surgery (ERAS) Society on perioperative...
SIRONA head-to-head randomised trial achieves 50% enrolment
Concept Medical recently announced that the SIRONA randomised controlled trial (RCT)—a head-to-head comparison of sirolimus versus paclitaxel drug-eluting balloon angioplasty in the femoropopliteal artery—has...
Endologix announces completion of enrolment in TORUS 2 study for PAD in SFA
Endologix has completed enrolment in the TORUS 2 investigational device exemption (IDE) clinical study in the USA, a press release reports.
The TORUS 2...
Philips IVUS linked with improved health outcomes in large-scale analysis of lower extremity peripheral...
Royal Philips today announced the results of a new large-scale, real-world analysis of Centers for Medicare & Medicaid Services (CMS) data on the health...
Vascular News’ top 10 most popular stories of September 2021
September's top 10 features five-year ACST-2 results, a new tool to assess amputation risk following popliteal vascular injury, and an interview highlighting the questions...
BIOPACT head-to-head non-inferiority randomised controlled trial completes enrolment
Biotronik is proud to announce the completion of enrolment of the investigator-initiated BIOPACT randomised controlled trial (RCT). This non-inferiority study evaluates the safety and...
Vascular News’ top 10 most popular stories of June 2021
New data from Philips' TOBA II below-the-knee (BTK) clinical trial, physicians' call for the AMPREDICT decision support tool to be applied in clinical practice,...
ACC.21: SAFE-PAD finds no increased risk of death with drug-coated devices used for lower...
Researchers have found no statistically significant difference in mortality between patients treated with drug-coated devices and non-drug-coated devices in the SAFE-PAD study. Eric Secemsky...
CX 2021 Industry Partner On-demand Content
CX 2021 Industry Partner On-demand Content
Satellite Symposium: Innovative approaches to address Aortic and Fem-Pop procedural challenges
Moderator:
Ross Milner, Chicago, United StatesSatellite Symposium: Occlusive Iliac artery pathology:...
“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,...
Debate over flow reduction in asymptomatic high-flow fistulas leaves CX 2021 audience split
Consensus is split over the need for flow reduction in high-flow fistulas to avoid cardiac complications in dialysis patients, polling taken during the Charing...
Episode 1: Go behind the scenes to delve into the birth and evolution of...
To mark the 20-year anniversary of drug-coated balloons, Bruno Scheller (Homburg/Saar, Germany) and Gunnar Tepe (Rosenheim, Germany), talk to Vascular News about their contributions...
Acute kidney injury is associated with medium-term mortality following endovascular intervention for PAD
Acute kidney injury is a common complication after intervention for peripheral arterial disease (PAD), and is associated with “medium-term mortality” following percutaneous transluminal angioplasty...
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...
Paclitaxel situation “crystallising” thanks to new data and teamwork, VIVA audience hears
This year's Vascular Interventional Advances annual meeting (VIVA 2020; 6–8 November, online) opened with a session on controversial hot topics and advanced multidisciplinary approaches...
DETOUR I two-year outcomes: “Excellent” functional improvement in complex PAD cohort
During a late-breaking data session at this year’s Vascular Interventional Advances annual meeting (VIVA 2020; 6–8 November, virtual), Ehrin Armstrong (University of Colorado, Denver,...
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...
Safety and efficacy of IN.PACT Admiral sustained out to five years
In a late-breaking data session at this year’s Vascular Interventional Advances conference (VIVA 2020; 6–8 November, virtual) Thomas Zeller (University Heart Center Freiburg, Bad...
“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...
“No signal of increased risk of long-term mortality” with paclitaxel-coated Luminor DCB, EffPac trial...
An ad hoc, two-year analysis of the EffPac study found no signal of increased risk of long-term mortality, nor any adverse events, within two...
Hence Verhagen
Hence Verhagen talks to Vascular News about his career in vascular surgery to date. He lauds the impact of the shift from open to...
MHRA: Warning to be added to paclitaxel device IFUs in Europe
In a new field safety notice, the UK Medicines and Healthcare products Regulatory Agency (MHRA) states that a warning and clinical summary section will...
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...
CX 2020 LIVE pioneers virtual vascular conference format in COVID-19 era
CX 2020 LIVE came to life online—despite COVID-19—using state-of-the art broadcast technology to bring together more than 1,000 vascular specialists, live, from 95 countries across...
Independent analysis, with oncology input, re-examines DCB data after paclitaxel mortality signal
Kenneth Ouriel (New York, USA) talks to BLearning Peripheral at LINC 2020 (Leipzig Interventional Course; 28–31 January 2020, Leipzig, Germany) about a recent independent analysis to assess safety...
MedAlliance receives CE mark approval for SELUTION SLR sirolimus drug-eluting balloon for endovascular applications
MedAlliance has announced the award of its first CE mark approval: for SELUTION SLR, a novel sirolimus drug-eluting balloon (DEB), for the treatment of...
German claims data report higher long-term and amputation-free survival in CLTI patients treated with...
There is no sign of increased all-cause mortality following the use of paclitaxel-coated devices for the treatment of symptomatic peripheral arterial occlusive disease, a...
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...
Reaction to the Katsanos et al meta-analysis
Internal BIBA MedTech data show that perceptions on paclitaxel devices have shifted considerably in the twelve months that have elapsed since Konstantinos Katsanos (Patras,...
Pivotal study of next-generation advancement in stent graft technology for PAD treatment initiated
The first patient has been enrolled in the TORUS 2 multicentre, clinical trial, evaluating the use of the self-expanding Torus stent graft system (PQ...
VIVA 2019: One-year freedom from clinically-driven target lesion revascularisation in MIMICS-3D registry
One-year results of the MIMICS-3D study were announced today at the 2019 Vascular Interventional Advances conference (VIVA; 4–7 November, Las Vegas, USA). Freedom from...
Real-world use of the Tack Endovascular System published
Intact Vascular has announced the peer-reviewed publication, “Practical applications of Tack implants for infrainguinal dissection repair: A single-centre experience” currently available online, with...
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...
Benefit and risk: Meta-analysis draws a heterogeneous picture of drug-coated balloon angioplasty
Scientists of Jena University Hospital, Germany, conducted a meta-analysis sought to evaluate benefit and risk of paclitaxel-coated balloon angioplasty compared to plain old balloon...
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...
No increased short- to midterm mortality among dialysis access patients treated with paclitaxel-coated balloon
A systematic review and meta-analysis, recently published in the Journal of Endovascular Therapy, found no difference in short- to midterm mortality among patients who...
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...
Medtronic statement regarding updated FDA letter to healthcare providers on paclitaxel devices to treat...
Medtronic has issued the following statement regarding the US Food and Drug Administration’s (FDA) updated letter to healthcare providers for paclitaxel-devices in patients with...
FDA: Paclitaxel device clinical trials “may continue”; Agency is working to change informed consent...
Clinical studies of paclitaxel-coated balloons and paclitaxel-eluting stents “may continue and should collected long-term safety (including mortality) and effectiveness data”, says the US Food...
MHRA issues medical device alert for paclitaxel use in the UK
Do not use paclitaxel drug-coated balloons (DCBs) or drug-eluting stents (DESs) in the routine treatment of patients with intermittent claudication until further notice, a...
MHRA limits routine clinical use of paclitaxel devices following expert advisory group advice
The UK Medicines and Healthcare products Regulatory Agency (MHRA) acted to limit the future use of paclitaxel-eluting stents and paclitaxel-coated balloons in routine clinical...
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...
The impact of paclitaxel concerns on vascular access
At the 2019 Charing Cross Symposium (CX; 15–18 April, London, UK), there was a section of the programme on drug-coated balloon trial updates which...
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...
While CX audience deems paclitaxel not dangerous, vascular pathologist says establishing “truth takes time”
Delegates voted overwhelmingly against the notion that there was a demonstrable danger in any organ of the body attributed to circulating paclitaxel. These polling...
CIRSE updates position on paclitaxel use in peripheral arteries
The Cardiovascular and Interventional Radiological Society of Europe (CIRSE) has released a statement on the use of paclitaxel-coated balloons and stents in the treatment...
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...
Pooled analysis of four RCTs finds no increased mortality with paclitaxel-coated devices over a...
A new paper looking specifically at mortality has found no difference in deaths between paclitaxel-coated balloons and uncoated balloons when used in the femoropopliteal...
Revised safety analysis of Medtronic’s IN.PACT Admiral DCB published in JACC
Medtronic has issued the following statement regarding revised clinical study data:
On 15 February, 2019, Medtronic issued a statement regarding a programming error in the...
Vascular Leaders Forum discussions seek consensus on paclitaxel
The Vascular Leaders Forum (VLF, 1–2 March, Washington DC, USA), hosted by the non-profit organisation VIVA Physicians, is a special consortium which was called...
“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...
Medtronic revises IN.PACT post-market study data due to programming error, but conclusions remain the...
Medtronic has issued the following statement regarding revised clinical study data:
Recently, Medtronic became aware of a programming error in the clinical data reporting isolated...
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...
Latest data from Philips reinforces the safety profile of Stellarex low-dose DCB
A new pooled analysis of patient-level data from Philips demonstrates the “strong safety profile” of the company's Stellarex drug-coated balloon (DCB) in above-the-knee studies,...
BASIL-3 and SWEDEPAD trials paused for review of paclitaxel meta-analysis data
The findings published by Konstantinos Katsanos and colleagues in JAHA quickly sparked wide-spread debate across the vascular community, as the meta-analysis’ implications and questions...
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...
US FDA evaluating paclitaxel data, recommend patient surveillance
The impact of the 2018 meta-analysis of randomised paclitaxel-device trials, published in the Journal of the American Heart Association by Konstantinos Katsanos et al,...
PQ Bypass announces US$60 million in financing for PAD treatment
Medical device company PQ Bypass has entered into an agreement that provides for up to an aggregate of US$60 million in equity financing, led...
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...
Pooled analysis of four RCTs finds drug-coated balloons superior to plain angioplasty in almost...
A pooled analysis of four randomised controlled trials finds drug-coated balloon (DCB) angioplasty superior to plain angioplasty in patients with femoropopliteal artery disease, irrespective...
SWEDEPAD 1 and SWEDEPAD 2 trials halt inclusion after Katsanos et al’s meta-analysis on...
Vascular News has learned that inclusion into the SWEDEPAD studies, that are examining benefits of drug-eluting technology for peripheral arterial disease patients, has been...
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...
Without additional long-term and patient-level data, Katsanos et al’s conclusion is premature
By Thomas Zeller
The Katsanos et al meta-analysis reports an increased risk of mortality beyond one year across randomised studies of paclitaxel-coated balloons (DCB) and...
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,...
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...
IN.PACT SFA Trial five-year data and Total IN.PACT All-Subjects analysis presented at VIVA
The five-year and final results from the pivotal IN.PACT SFA Trial and one-year all-subjects results from the Total IN.PACT Pooled Analysis of the IN.PACT...
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...
BioMimics 3D stent receives US FDA premarket approval
UK-based Veryan Medical has announced that the company has received premarket approval (PMA) for their BioMimics 3D vascular stent system from the US Food...
Five-year evaluation of Zilver PTX stent in a real-world population continues to show favourable...
Five-year results from a Japanese post-market surveillance study aimed at evaluating the Zilver PTX drug-eluting stent (DES) in a real-world population show consistently positive...
Live from CIRSE 2018: Three-year results from global study confirm the safety of the...
The largest prospective, independently-adjudicated study of drug coated balloons (DCBs) in a broad range of lesions in real-world patients confirms the safety and performance...
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...
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...
DETOUR I 12-month data show promising durability of bypass system
Results from the DETOUR I trial evaluating the DETOUR System (PQ Bypass) for percutaneous bypass showed promising 12-month durability for patients with extremely long...
MIMICS-3D registry completes enrolment
Veryan Medical has announced completion of enrolment of the 500th patient in the MIMICS-3D pan-European registry, a prospective, multicentre, observational registry to evaluate the...
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),...
MIMICS-2 shows 90% freedom from target lesion revascularisation at one year with swirling flow...
The BioMimics 3D (Veryan Medical) helical swirling flow stent system provides an alternative to antiproliferative drugs, according to one-year data from the MIMICS-2 trial....
Multiple stent delivery system continues to show safe and effective results at 12 months...
Data from the LOCOMOTIVE registry first-in-man trial investigating the VascuFlex Multi-Loc, B Braun’s multiple stent delivery system, were presented by Klaus Amendt (Diakonissenkrankenhaus, Mannheim,...
How would you treat these lesions?
This educational supplement is for distribution within Europe only.
In this supplement:
The rationale of directional atherectomy and DCB angioplasty for the treatment of “no-stent zones”
CASE #1:...
One-year MIMICS-2 results show BioMimics 3D stent results in nearly 90% freedom from target...
Thomas Zeller (Bad Krozingen, Germany) presented the 12-month results from Veryan Medical’s MIMICS-2, a prospective, single arm, multicentre clinical study to evaluate the safety...
PQ Bypass receives IDE approval to initiate pivotal DETOUR II clinical trial
PQ Bypass has received conditional approval of its investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate the pivotal...
New Mimics data support use of the BioMimics 3D swirling flow stent in primary...
New significant outcomes from the Mimics study have been presented at the 15th annual conference on Vascular Interventional Advances (VIVA; 11-14 September, Las Vegas,...
Contego Medical announces ENTRAP Study initiation for Vanguard IEP peripheral balloon angioplasty system with...
Contego Medical has announced the initiation of the ENTRAP Study evaluating usage of its Vanguard IEP peripheral balloon angioplasty system with integrated embolic protection...
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...
PQ Bypass announces CE mark for Detour percutaneous bypass technologies
PQ Bypass has announced CE mark approval for a trio of proprietary devices: the Torus stent graft system, PQ Snare, and PQ Crossing Device,...
ATTRACT fails to meet primary endpoint, but experts agree results are “hypothesis-generating”
Data from the randomised controlled ATTRACT trial revealed that the addition of catheter-based intervention to standard-of-care anticoagulation failed to significantly decrease the occurrence of...
Global cohorts report drug-coated balloon success above the knee and “promising” results below the...
Three global registries reported fresh data at the 2017 Leipzig Interventional Course (LINC; 24–27 January, Leipzig, Germany), all of which showed encouraging outcomes for...
Promising 12- and 24-month East Asian experiences for drug-coated balloons
Results from two Asian studies presented at LINC 2017 (24–27 January, Leipzig, Germany), show encouraging outcomes for drug-coated balloon versus percutaneous transluminal angioplasty treatment...
Medtronic announces Health Canada licence for IN.PACT Admiral drug-coated balloon
Medtronic Canada, a subsidiary of Medtronic, has announced it has obtained Health Canada licence for the IN.PACT Admiral drug-coated balloon. IN.PACT Admiral is a primary...
LEG-DEB registry reports encouraging six-month interim analysis for LegFlow
Six-month interim analysis of the Legflow drug-eluting balloon for the treatment of femoropopliteal occlusions (LEG-DEB) registry indicates that “the use of a new generation...
SUPERFAST results show advantage of Supera for chronic total occlusions
New data from a propensity matched prospective study suggest the Supera stent (Abbott Vascular) delivers superior results when compared to older generation nitinol stents...
Lutonix Global Real-World Registry 24-month outcomes presented at VIVA 2016
Bard has announced the presentation of the final 24-month results from the Lutonix Global Real-World Registry at the Vascular Intervention Advances (VIVA) 2016 meeting...
Six-month Shockwave Medical Disrupt PAD data show “consistent and predictable” procedural success
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...
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...
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...
UK NICE publishes Medtech Innovation Briefing on Lutonix
The UK National Institute for Health and Care Excellence (NICE) has developed a Medtech Innovation Briefing (MIB) on the Lutonix drug-coated balloon (DCB) for...
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...
New IN.PACT Admiral data reinforce efficacy in females, chronic total occlusions and patients with...
Medtronic has announced with several new presentations that showed durable and consistent clinical outcomes in the most challenging patients with peripheral artery disease. The...
Charing Cross Symposium 2016: Tackling the challenges in the vascular and endovascular arena
Halfway through its Controversies, Challenges and Consensus cycle, the Charing Cross Symposium will examine this year the numerous and varied challenges currently facing the...
Boston Scientific receives CE mark for Eluvia drug-eluting stent, begins IMPERIAL trial
Boston Scientific has received CE mark for the Eluvia drug-eluting vascular stent. It is to begin commercialisation of the product immediately in countries which...
Real-world comparison shows similar efficacy between Bard Lutonix and Medtronic IN.PACT drug-coated balloons
Results presented at LINC 2016 revealed no significant difference at 18 months in target lesion revascularisation and sustained clinical improvement between the Lutonix and the IN.PACT drug-coated balloons. Clinical improvement was measured by improvement in Rutherford class from baseline or prior to drug-coated balloon treatment.
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....
Meta-analysis on nitinol stents shows higher ankle-brachial index and shorter lesions result in better...
In a presentation at the 2015 Vascular Interventional Advances meeting (VIVA; 2–5 November, Las Vegas, USA), Krishna Rocha-Singh, St John’s Hospital, Springfield, USA, gave...
Veryan Medical sets up German direct sales operation for BioMimics 3D peripheral self-expanding stent
Veryan Medical set up a direct sales operation in Germany through which it will sell its BioMimics 3D peripheral self-expanding stent system.
Chas Taylor,...
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...
IN.PACT Admiral cost-effectiveness study and results for in-stent restenosis highlighted at VIVA
Medtronic has added to the data for its IN.PACT Admiral drug-coated balloon with the presentation of both its formal cost-effectiveness analysis from the US cohort of...
Sebastian Debus
Sebastian Debus is taking over as secretary-general of the European Society for Vascular Surgery (ESVS) for a five-year term this September. Professor and Chairman,...
Eluvia drug-eluting stent demonstrates 96.1% primary patency at 12 months
According to Boston Scientific, these results represent the highest 12-month primary patency reported for an interventional treatment of femoropopliteal artery lesions among comparable trials.
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.
First patient enrolled in Veryan Medical’s MIMICS-2 study
The study will evaluate the BioMimics 3D stent system against the performance goals defined by VIVA Physicians for the safety and effectiveness of nitinol stents used in the treatment of symptomatic disease of the femoropopliteal artery.
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.
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.
Boston Scientific and Bard announce distribution agreement for Lutonix
Agreement extends reach of Lutonix drug-coated balloon to prepare and treat diseased femoropopliteal vessels.
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...
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...
Veryan’s BioMimics 3D nitinol stent shows improved patency at two-year follow-up
Two-year data from the Mimics study, presented at the late-breaking clinical trials session at the VIVA Symposium, have confirmed that BioMimics 3D provides a significant improvement in long-term primary patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention.
Not all drug-eluting balloons are equal
By Thomas Zeller
Following successful first-in-man trials (THUNDER, FEMPAC) using the Paccocath/Cotavance coating technology (Bayer, iopromide & 3µg/m2 paclitaxel), two recently presented major pivotal trials...
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.
EXCITE ISR shows superiority of laser atherectomy over angioplasty alone
The study results presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference demonstrated a 93.5% procedural success rate of laser with angioplasty vs. 82.7% with angioplasty alone.
Humacyte receives fast track designation for HumaGraft for vascular access in haemodialysis programme
HumaGraft is being developed to help provide reliable and robust vascular access for haemodialysis patients with end stage renal disease and to reduce or avoid certain serious complications that arise with the current standards of care associated with the current forms of vascular access for haemodialysis.
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.
LEVANT 2 one-year results presented at FDA panel meeting
Data from the LEVANT 2 trial comparing the Lutonix drug-eluting balloon with angioplasty alone in the treatment of peripheral arterial disease show that the primary endpoints of both safety and efficacy were met and superior efficacy and non-inferior safety of Lutonix compared to control angioplasty was demonstrated.
EXCITE trial data demonstrate acute, superior procedural success
The Excimer laser randomised controlled study for treatment of femoropopliteal in-stent restenosis (EXCITE ISR) showed a 93.5% procedural success rate with laser atherectomy plus percutaneous transluminal angioplasty for the treatment of in-stent restenosis versus 82.7% with percutaneous transluminal angioplasty alone.
Large real-world experience shows positive results with Zilver PTX in challenging patient population
A post-market surveillance study of the Zilver PTX drug-eluting stent conducted in Japan has shown positive results with the device in the treatment of femoropopliteal lesions. According to the investigators, the results "confirm the benefit of the Zilver PTX technology".
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...
Two-year MIMICS data confirm long-term patency protection with BioMimics 3D
Two-year follow-up data have shown that BioMimics 3D, a nitinol stent with unique three-dimensional helical geometry, provides an improvement in long-term patency compared to a straight nitinol control stent in patients undergoing femoropopliteal artery intervention for symptomatic peripheral arterial disease.
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.
Low-dose Lutonix drug-eluting balloon shows lower late lumen loss than plain angioplasty at six...
Treatment of femoropopliteal lesions with the device reduces late lumen loss with safety comparable to that of control angioplasty, according to LEVANT I trial results published in JACC: Cardiovascular Interventions.
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.
Thomas Zeller
Thomas Zeller, head, Department of Angiology at Universitäts—Herzzentrum Freiburg, Bad Krozingen, Germany, says that interventional angiology “almost did not exist” when he performed his...
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.
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.
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.
Positive 12-month results for the Passeo-18 Lux paclitaxel-eluting balloon
New device showed higher freedom from target lesion revascularisation and reduced late lumen loss and restenosis in comparison with uncoated balloon catheter in femoropopliteal lesions.
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.
Final results of PATENT study support successful use of laser atherectomy for treating patients...
Data presented by Thomas Zeller at LINC indicate 82% and 52% freedom from target lesion revascularisation at six and 12 months, respectively, with procedural success rate at 98.9%.
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.
What is the impact of drug-eluting balloons in Europe?
By Nicolas Diehm
Endovascular therapy has matured to be the primary revascularisation strategy for about 90% of patients with peripheral arterial disease (EVEM panel data...
First US patient treated following FDA approval of Zilver PTX drug-eluting stent
Just weeks after the FDA approved Cook Medical's Zilver device, Riverside Methodist Hospital in Columbus, USA, has treated the first patient with the device as part of Cook's US commercial launch.
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.
CONNECT II clinical trial completes enrolment
Avinger has announced that it has successfully completed enrolment in its CONNECT II global clinical trial. A study focused on treatment of peripheral artery disease.
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...
Avinger enrols first European patient in CONNECT II global clinical trial
CONNECT II is a multicentre, non-randomised study designed to evaluate the safety and efficacy of Ocelot, Avinger's first therapeutic catheter to incorporate optical coherence tomography.
UH Case Medical Center enrols first patient in LEVANT 2 trial
LEVANT 2 will investigate whether the Moxy drug-coated balloon (Lutonix) is more effective than standard angioplasty at keeping leg arteries open and free from re-blockage over time.
FDA approves the Wildcat catheter for crossing chronic total occlusions
Results from the CONNECT trial demonstrated that Wildcat (Avinger) was able to cross 89.3% (efficacy) of chronic total occlusions in peripheral artery disease that were not crossable with standard guidewire techniques while maintaining a 95.2% safety profile.
Spectranetics announces first patient enrolled in EXCITE ISR clinical trial
The study will compare the safety and efficacy of excimer laser atherectomy utilising the Turbo-Tandem and Turbo Elite products with balloon angioplasty, compared with angioplasty alone.
TASC guidelines set to recommend “endovascular first” for all lesions
The new guidelines are set to recommend an endovascular first strategy, even for TASC D lesions. However, TASC IIb remains unpublished as vascular surgical societies have so far failed to endorse these recommendations. A criticism levelled at TASC has been the "fundamentally flawed" decision to change the lesion categorisation repeatedly, which was described as "shifting the goalposts"
Eurocor launches peripheral drug-eluting balloon
The Freeway is the latest second-generation angioplasty balloon technology designed for the treatment of critical limb ischaemia associated with peripheral arterial disease.
First patient enrolled in CONNECT clinical trial
Avinger has announced the enrolment of the first patient in the CONNECT (Chronic total occlusion crossing with the WildCat Catheter) clinical trial.
Maquet announces first patient enrolled in clinical trial of Fusion vascular grafts
The first patient was enrolled by Wei Zhou at VA Palo Alto Health Care System in Palo Alto, USA.
DUET compares standard catheter-directed vs. ultrasound-accelerated thrombolysis
The DUET study, a randomised trial conducted to compare standard catheter-directed thrombolysis vs. ultrasound-accelerated thrombolysis in The Netherlands, has begun enrolment of its 60 thrombo-embolic infra-inguinal disease patients.
John Mannick
Vascular News talks to John Mannick of the Brigham and Women’s Hospital about entering vascular surgery by the toss of a coin, and winning...
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.
Heparin-bonded PTFE claims superior patency above the knee
First randomised study of heparin-bonded expanded polytetrafluoroethylene grafts shows a clear trend towards improved patency in femoropopliteal bypass.
Drug-eluting stents too expensive, say CX delegates
Delegates at the CX Symposium say the economic climate means drug-eluting stents are not a realistic treatment option in the superficial femoral artery
New toys for old boys – the CLI tool box revisited
By Florian Dick
Infrapopliteal disease is the most frequent cause of major amputations and this is also one of the vascular regions where currently some...
The Great Debates at CX
Charing Cross is famous for its 'Great Debates'
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.
GORE PROPATEN vascular graft launched at VEITH
The GORE PROPATEN Vascular Graft is specifically designed for those vascular procedures in which the risk of acute graft thrombotic failure is of clinical concern.
What is the level of evidence for stenting in the superficial femoral artery?
Comments by Professor Johannes Lammer
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
New trials to evaluate stenting in peripheries
Vascular News reports of two company-sponsored trials
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
Cook focuses on paclitaxel-eluting devices for the periphery
Cook restructures its license agreement with Angiotech
