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Amazon executive joins Medtronic to spearhead development in robotics and implantables
Medtronic has announced that Ken Washington has been appointed chief technology and innovation officer.
Washington joins Medtronic from Amazon where he served as vice president...
Medtronic announces first enrolment in head-to-head global randomised trial evaluating durability of EVAR
Medtronic has announced the first patient enrolment in the ADVANCE trial, a head-to-head randomised controlled trial of two leading aortic stent graft systems, the...
Medtronic receives CE mark for the first balloon-expandable covered stent indicated for ChEVAR
Medtronic announced that it has recently received CE mark for its Radiant balloon-expandable covered stent, the first and currently, only, covered stent indicated for...
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...
Medtronic names Laura Mauri as new chief scientific, medical and regulatory officer
Medtronic has announced that Laura Mauri has been appointed as the company’s chief scientific, medical and regulatory officer. This appointment adds to Mauri's prior responsibilities...
Cydar Medical announces strategic collaboration with Medtronic
Cydar Medical recently announced it has entered a strategic collaboration with Medtronic. Under the pilot arrangement, Cydar’s EV Maps software will be introduced to...
Medtronic issues voluntary recall for subset of IN.PACT Admiral and IN.PACT AV DCBs due...
Medtronic recently voluntarily recalled a subset of its IN.PACT Admiral and IN.PACT AV paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential...
Medtronic expands reach of AI-powered surgical video management and analytics platform
Medtronic has announced that it has entered into a contract with Vizient to add Touch Surgery Enterprise, an AI-powered surgical video management and analytics...
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...
Medtronic announces 2045 net zero emissions ambition to combat climate change
Medtronic has announced its ambition to achieve net zero carbon emissions by fiscal year 2045 across its operations and value chain to accelerate efforts...
Medtronic unveils data on hypertension treatment preferences, launches SPYRAL AFFIRM study
Medtronic today announced findings from a new study of patient preferences for the treatment of hypertension. The findings are set to be presented during...
Medtronic receives CE mark approval for radial artery access portfolio
Medtronic today announced it has received CE mark approval for its radial artery access portfolio, which includes the Rist radial access selective catheter and the Rist...
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...
Medtronic provides updated patient management recommendations regarding Valiant Navion recall
This week Medtronic announced that it has sent physicians updated patient management recommendations related to its voluntary recall of the Valiant Navion thoracic stent...
EuroPCR 2021: Late-breaking data demonstrate long-term benefits of Medtronic radiofrequency renal denervation in real-world...
Medtronic today announced new clinical data from the Global SYMPLICITY registry (GSR) indicating that renal denervation with the Medtronic Symplicity renal denervation system was...
Medtronic launches Chameleon PTA balloon catheter in selected countries
Medtronic recently announced the launch of its Chameleon percutaneous transluminal angioplasty (PTA) balloon catheter in the following countries: Germany, Italy, Portugal, South Africa, Spain,...
Medtronic launches IN.PACT AV DCB in Japan for patients undergoing haemodialysis
Medtronic has announced the launch of IN.PACT AV drug-coated balloon (DCB) in Japan. IN.PACT AV DCB is indicated for the treatment of obstructive lesions...
Medtronic announces voluntary recall of unused Valiant Navion thoracic stent graft system
Medtronic has voluntarily issued a global recall of its Valiant Navion thoracic stent graft system and informed physicians to immediately cease use of the...
Medtronic to acquire Avenu Medical
Medtronic today announced the planned acquisition of Avenu Medical, a medical device company focused on the endovascular creation of arteriovenous (AV) fistulae for patients...
Medtronic begins real-world, post-market study of Valiant Navion in patients with thoracic aortic dissection
Medtronic today announced the start of a prospective, observational, global, multicentre, real-world, post-market study to evaluate the safety and effectiveness of the Valiant Navion...
Medtronic provides ventilator progress update
Medtronic has announced updates regarding its efforts to increase ventilator production around the globe. The company is announcing progress in the ramp-up of its...
Medtronic shares ventilation design specifications to accelerate efforts to increase global ventilator production
Medtronic has announced it is publicly sharing the design specifications for the Puritan Bennett 560 (PB 560) to enable participants across industries to evaluate...
Medtronic begins pilot study as part of SPYRAL HTN clinical programme for renal denervation...
Medtronic has announced that it will begin enrolment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation (RDN)...
Medtronic IN.PACT™ AV DCB, now approved for AV fistula maintenance in the US
Watch Andrew Holden (Auckland, New Zealand) present the six-month results of the IN.PACT AV Access trial. The multicentre, prospective, randomised controlled trial shows that treatment...
Medtronic presents one-year Valiant Navion, four-year ANCHOR registry clinical outcomes
Medtronic has announced one-year outcomes for the Valiant Navion thoracic stent graft system for thoracic endovascular repair (TEVAR) and four-year clinical outcomes from the ANCHOR...
Medtronic DCB receives US FDA approval to treat arteriovenous fistula lesions
Medtronic today announced US Food and Drug Administration (FDA) approval of the IN.PACT AV drug-coated balloon (DCB), a paclitaxel-coated balloon indicated for the treatment...
Medtronic announces Shonin approval and launch of the Valiant Navion thoracic stent graft system...
Medtronic today announced Shonin approval from the Ministry of Health, Labour and Welfare (MHLW) and the launch of the Valiant Navion thoracic stent graft...
BIBA Briefings: Medtronic receives US FDA Breakthrough Device Designation for complex EVAR device
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Medtronic for its novel Valiant thoracoabdominal aneurysm (TAAA) stent graft. A...
Medtronic receives FDA breakthrough device designation for its Valiant Navion LSA branch thoracic stent...
Medtronic today announced it has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Valiant TAAA stent graft system...
Omar Ishrak to step down as Medtronic CEO next year
Omar Ishrak, Medtronic’s chairman and CEO is to retire on 26 April 2020, following the end of the company’s current fiscal year. Also, the...
Omar Ishrak to step down as Medtronic CEO next year
Omar Ishrak, Medtronic’s chairman and CEO is to retire on 26 April 2020, following the end of the company’s current fiscal year. Also, the...
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...
Medtronic and BD respond to FDA circulatory system devices panel
Both Medtronic and BD have released statements in response to the FDA circulatory system devices panel held last week (19–20 June, Washington, DC, USA)....
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...
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...
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...
US FDA approve new study of Medtronic’s Spyral renal denervation system
The FDA have given Medtronic approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system in patients with hypertension who...
Expanding patient care options with Medtronic
This article is an advertorial by Medtronic.
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic Inc. offers the broadest range of innovative medical...
Medtronic receives US FDA clearance for 200mm and 250mm IN.PACT Admiral drug-coated balloons
Medtronic has announced that it has received US FDA approval for 200mm and 250mm lengths of the IN.PACT Admiral drug-coated balloon (DCB) to treat...
Medtronic launches ChEVAR parallel graft technique study using Endurant II/IIs
Medtronic has announced the launch of the ENCHANT (Endurant ChEVAR New Indication Trial) study. The post-market, non-interventional, multi-centre, non-randomised, single-arm study will enrol approximately...
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...
First patient enrolled in study of Medtronic IN.PACT arteriovenous access drug-coated balloon
The first patient has been enrolled in Medtronic’s IN.PACT arteriovenous (AV) access drug-coated balloon (DCB) study for use in patients with end-stage renal disease.
The...
QT Vascular enters into asset purchase option agreement with Medtronic
QT Vascular has entered into an asset purchase option agreement with Medtronic for the acquisition of the group's non-drug coated Chocolate percutaneous transluminal angioplasty...
Five-year Medtronic ENGAGE Registry data show positive real-world outcomes for Endurant II
Medtronic has reported that its Endurant II abdominal aortic aneurysm (AAA) stent graft system continues to demonstrate long-term durability and consistent outcomes in a...
Consistent results for Medtronic IN.PACT Admiral in complex peripheral artery disease analyses
Two new sub-analyses from the IN.PACT Global Study of the IN.PACT Admiral in patients with peripheral artery disease have been reported at the annual...
Medtronic launches European below-the-knee clinical study of drug-coated balloon
Medtronic has launched the IN.PACT BTK study to evaluate the effectiveness of using a drug-coated balloon in patients with below-the-knee (BTK) peripheral artery disease.
This...
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...
Medtronic to distribute QT Vascular’s Chocolate balloon worldwide
QT Vascular has signed a definitive agreement with Medtronic, for the worldwide distribution of its Chocolate percutaneous transluminal angioplasty (PTA) catheter for a period...
US FDA grants Medtronic investigational device exemption for IN.PACT Admiral AV fistula study
Medtronic has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a study of the IN.PACT Admiral...
Results from Asia and Belgium demonstrate consistent results from Medtronic IN.PACT Admiral
New data presented at the 2017 Leipzig Interventional Course (LINC) have demonstrated strong efficacy and consistent outcomes for Medtronic’s IN.PACT Admiral drug-coated balloon across...
Medtronic receives CE mark for lower-profile HawkOne directional atherectomy system
Medtronic has been granted CE mark approval for the HawkOne directional atherectomy system in a lower profile size for treating patients with peripheral artery...
Medtronic Endurant II/IIs granted CE mark for ChEVAR parallel graft technique
Medtronic has received CE mark for its Endurant II/IIs stent graft system to treat abdominal aortic aneurysm patients using a ChEVAR procedure—a parallel graft...
Enhanced outcomes found for Medtronic Heli-FX EndoAnchor patients with complex aortic abdominal aneurysm anatomy
Medtronic has announced data demonstrating that the company's Heli-FX EndoAnchor system enhances outcomes and durability in patients with complex aortic abdominal aneurysm (AAA) anatomy,...
Medtronic receives FDA clearance of new lower profile HawkOne 6F directional atherectomy system
Medtronic has received US Food and Drug Administration (FDA) 510(k) clearance for the HawkOne Directional Atherectomy System in a new size for treating...
Medtronic receives FDA clearance of TrailBlazer angled peripheral support catheter
The US Food and Drug Administration (FDA) has cleared Medtronic’s TrailBlazer angled support catheter for use in the peripheral vascular system.
The TrailBlazer angled support...
Medtronic Valiant Captivia demonstrates safety and efficacy at three years
Medtronic has announced new data, demonstrating safety and efficacy at three years in acute complicated type B aortic dissection patients treated with the Valiant Captivia thoracic...
New data demonstate durability, safety and efficacy for Medtronic’s In.Pact Admiral drug-coated balloon
New data, presented in a series of late-breaking clinical trial presentations at the Vascular Interventional Advances (VIVA) 2016 conference in Las Vegas, USA, have...
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...
Medtronic receives FDA approval for IN.PACT Admiral DCB 150mm lengths
Medtronic has received US Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon (DCB) in longer, 150mm lengths. The 150mm length...
First Medtronic Valiant Evo thoracic stent graft system procedure completed in clinical study
Medtronic and the University of Texas Health Science Center at Houston (UTHealth) have announced the first patient enrolled in a clinical study assessing the...
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.
Medtronic IN.PACT Admiral DEB granted CE mark for treatment of AV access in patients...
The IN.PACT Admiral drug-eluting balloon (DEB) has been granted CE mark for arteriovenous (AV) access to help maintain haemodialysis access in patients with end-stage...
Medtronic to manufacture IN.PACT Admiral drug-coated balloon at new high-tech facility
Medtronic will manufacture the IN.PACT Admiral drug-coated balloon (DCB) for the treatment of peripheral artery disease (PAD) at a new facility in Galway, Ireland.
According...
New aortic and peripheral data from two late-breaking trials revealed by Medtronic
New clinical data in interventional treatments for aortic and peripheral vascular diseases have been revealed by Medtronic during a late-breaking trial session at Vascular...
Medtronic drug-coated balloon sustains superiority over balloon angioplasty at two years in patients with...
The IN.PACT Admiral drug-coated balloon (DCB) provides superior clinical outcomes at two years compared to standard balloon angioplasty for the interventional treatment of peripheral arterial disease...
Medtronic to unveil new clinical data at TCT
Medtronic has announced a preview of notable clinical studies that will be presented at the annual Transcatheter Cardiovascular Therapeutics (TCT) symposium (11–15 October, San...
Medtronic’s Valiant thoracic stent graft system demonstrates durability after five years
Medtronic has announced favourable five-year data in the VALOR II study, demonstrating the durability of the Valiant thoracic stent graft system, an innovative and...
Medtronic completes first European patient cases with Endurant Evo AAA stent graft system
The first two European patient cases with the Endurant Evo AAA stent graft system were successfully performed by Hence Verhagen, chief of vascular surgery and his team at the Erasmus Medical Center in Rotterdam, the Netherlands.
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.
Medtronic acquires Aptus Endosystems
Aptus Endosystems' Helical Anchor Technology complements Medtronic's aortic stent platform for the treatment of complex aortic disease.
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.
Medtronic starts clinical study of Endurant Evo AAA stent graft system
The system is an investigational medical device designed to expand the applicability of a minimally invasive alternative to open surgical repair for the treatment of abdominal aortic aneurysms.
Medtronic begins enrolment in feasibility study of Valiant Mona LSA branch thoracic stent graft...
Investigational device enables endovascular repair of aortic aneurysms encroaching on left subclavian artery.
Medtronic to develop stent graft for thoracoabdominal aneurysms under patent license agreement with Sanford...
Medtronic announced on 14 April 2015 that it plans to develop a stent graft system for less invasive treatment of thoracoabdominal aortic aneurysms under an exclusive patent license agreement with South Dakota-based Sanford Health.
Medtronic initiates US launch of HawkOne directional atherectomy system
The HawkOne system can be used to treat all plaque morphologies in patients with peripheral arterial disease, including patients who have plaque blockages that have become severely calcified.
Medicare approves transitional pass-through payment for outpatient use of Medtronic drug-coated balloon
Decision provides supplemental reimbursement to US hospitals for new medical device with potential to improve standard of care for peripheral arterial disease in upper leg.
Medtronic’s pending acquisition of Covidien approved by Irish High Court
The Irish High Court has sanctioned the Covidien scheme of arrangement pursuant to which Medtronic will acquire Covidien under a new holding company incorporated in Ireland to be named Medtronic plc.
Medtronic drug-coated balloon tops standard balloon angioplasty in landmark study
The study indicates that Medtronic's In.pact Admiral drug-coated balloon significantly outperformed standard balloon angioplasty in the treatment of symptomatic peripheral artery disease in the upper leg.
Medtronic publishes latest Endurant AAA stent graft clinical study results
Medtronic has announced the latest results from two clinical studies analysing the performance of the Endurant AAA stent graft system.
Medtronic acquisition of Covidien receives US Federal Trade Commission and European Commission clearance
The US Federal Trade Commission (FTC) has given clearance of Medtronic's proposed acquisition of Covidien.
Medtronic launches Endurant IIs in Europe and the United States
According to the company, the new bifurcated component leverages proven design of predicate device and expands anatomical customisation options for endovascular repair of abdominal aortic aneurysms.
Medtronic drug-coated balloon for peripheral artery disease also benefits patients with diabetes
Medtronic's IN.PACT Admiral drug-coated balloon, used for the treatment of peripheral artery disease in leg arteries above the knee, provided a consistently favourable treatment effect in patients with diabetes in a landmark study of the investigational medical device, which is under review by the US Food and Drug Administration (FDA) for approval.
Medtronic announces executive team for the organisation upon Covidien acquisition
The new company will be comprised of four major business groups and four geographic regions led by a new Executive Committee. Omar Ishrak will remain as chairman and chief executive officer of the new company, Medtronic plc.
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.
Medtronic expands availability of aortic and peripheral solutions to US market
Valiant Captivia thoracic stent graft system proximal FreeFlo tapers line extension now with dissection indication, and the TOTAL across crossing support catheter for peripheral artery disease in the below-the-knee vessel bed are now available to physicians in the United States.
Volcano will acquire Pioneer Plus re-entry catheter from Medtronic
The Pioneer Plus re-entry catheter, which has regulatory clearance in the USA and Europe as well as other geographies, is an interventional device designed to enable the crossing of sub-total, total and chronic total occlusions within the peripheral vasculature.
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.
Medtronic receives FDA approval for aorto-uni-iliac Endurant II
The stent graft is now the only FDA-approved AUI device indicated for the treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients whose anatomy does not allow for the use of a bifurcated device.
Medtronic receives the CE mark for Sentrant introducer sheath
According to Medtronic, distinguishing features of Sentrant include optimal seal, reinforced coil, hydrophilic coating and flexibility, radiopaque marker and a dilator locking mechanism.
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.
Medtronic launches lower-extremity indication for Complete SE vascular stent internationally
The company announced the CE mark and international launch of the device for use in the lower extremities, specifically the superficial femoral arteries and proximal popliteal arteries.
Medtronic launches Amphirion Plus PTA Catheter for below-the-knee arteries
The Amphirion Plus PTA Catheter is designed to treat peripheral arterial disease. With an over-the-wire diameter of 0.014 inches, it joins the Amphirion Deep PTA Balloon Catheter, which targets lesions in arteries below the ankle.
Medtronic launches Endurant II in the USA
On 6 June 2012, Medtronic announced the US launch of the Endurant II Abdominal Aortic Aneurysm Stent Graft System, which recently received approval from the FDA.
Medtronic expands availability of Valiant Captivia Stent Graft in major global markets
Medtronic has announced the availability of the Valiant Captivia Thoracic Stent Graft System for endovascular repair of aortic aneurysms in China, Japan and the United States.
Medtronic joins Vascular Disease Foundation’s Corporate Roundtable
The Vascular Disease Foundation's Corporate Roundtable serves as a forum for dialogue between key industry representatives and most recognised thought leaders in the US vascular arena.
Medtronic introduces two next-generation cardiovascular devices in Japan
Medtronic announced plans to introduce in Japan the Integrity coronary stent system for the treatment of atherosclerosis and the Endurant AAA stent graft system for the treatment of abdominal aortic aneurysms.
Medtronic completes enrolment in clinical study of Complete Self-Expanding Vascular Stent
Milestone shows progress on indication-specific trials for treating peripheral arterial disease.
Medtronic completes enrolment for clinical study of Complete SE vascular stent
Milestone shows progress on indication-specific trials for treating peripheral arterial disease.
Medtronic completes acquisition of Invatec
The acquisition includes affiliated companies Fogazzi, which provides proprietary polymer technology to Invatec; and Krauth Cardio-Vascular, which has grown Invatec's market position in Germany.
Medtronic receives FDA approval for new indication for Complete self-expanding stent
Now indicated for treatment of peripheral disease in the iliac arteries, device redefines deployment accuracy for precise placement.
Medtronic strengthens peripheral pipeline with Invatec buy
Medtronic's acquisition of Invatec will enable the company to arm its peripheral vascular product range and obtain four drug-eluting balloons, currently being hailed as one of the most promising interventional devices.
Medtronic introduces 3D Recon service to enhance endovascular treatment of aortic aneurysms
Global partnership with Vital Images leverages advanced visualisation technology to streamline pre-case planning through patient follow-up.
Medtronic launches Valiant Thoracic Stent Graft at CX Symposium
This year's CX Symposium will see the introduction of Medtronic's innovative thoracic endograft device, the Valiant Thoracic Stent Graft with Xcelerant Delivery System.
CX 2023: IN.PACT AV three-year subanalysis trial data show “durable” long-term results
The vascular access masterclass session on Tuesday saw a first-to-podium presentation by Andrew Holden (Auckland City Hospital, Auckland, New Zealand) in which he presented...
Real-world data consistent with RCTs in highlighting the efficacy of drug-eluting technology
This advertorial is sponsored by Boston Scientific.
During a recent satellite symposium, which took place at the 2022 Cardiovascular Interventional Radiological Society of Europe (CIRSE)...
Endurant stent graft proves efficacious and durable in ENGAGE 10-year data
A first-to-podium presentation at the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK) saw Hence Verhagen (Erasmus Medical Center, Rotterdam, The Netherlands)...
Short neck AAAs: “Choosing what is best for the patient”
Navigating cases of abdominal aortic aneurysm (AAA) with short neck anatomy pose a serious challenge to vascular surgeons, but the list of potential options...
Study highlights need for “continuous comparative assessments” to guide endograft treatment decisions
A recent study comparing outcomes of endovascular aneurysm repair (EVAR) patients has reported no statistically significant differences in mortality or secondary rupture rates between...
Cost effectiveness of urea-based DCB treatment for CLTI patients “extremely important”
A range of experts, including Koen Deloose (Dendermonde, Belgium), Thomas Zeller (Bad Krozingen, Germany), Marianne Brodmann (Graz, Austria) and Antonio Micari (Messina, Italy), talk...
BIOPACT RCT suggests Passeo-18 Lux DCB non-inferior to IN.PACT Admiral DCB
Koen Deloose (Dendermonde, Belgium) talks to Vascular News about the key one-year data from the BIOPACT randomised controlled non-inferiority trial, which evaluated the safety...
IN.PACT Admiral DCB a cost-effective treatment for CLTI new study shows
Michel Reijnen (Arnhem, The Netherlands) presents the results of a study that sought to assess the potential cost-effectiveness of a urea-based drug-coated balloon (DCB;...
Experts react to “compelling” 36-month IN.PACT AV Access trial data
NOTE: This video is ONLY available to watch in selected countries and geographies
Robert Shahverdyan (Hamburg, Germany), Matteo Tozzi (Varese, Italy), Alexandros Mallios (Paris,...
ESC and EAPCI publish renal denervation consensus statement
Renal denervation represents another treatment option in patients with uncontrolled resistant hypertension and may be used in selected patients deemed intolerant to antihypertensive drugs.
These...
Cydar Medical raises US$11.5m in Series A funding round, appoints new chairman
Cydar Medical recently announced it has successfully completed a US$11.5 million (£9.3 million) Series A funding round including a US$3.7 million (£3 million) cornerstone...
Vascular News’ top 10 most popular stories of January 2023
January's top 10 highlights an individual patient data meta-analysis on the safety of carotid endarterectomy in the elderly and a new randomised trial on...
Roundtable: Will latest IN.PACT AV Access data impact practice and can this DCB treatment...
NOTE: This video is ONLY available to watch in selected countries and geographies
In this Vascular News roundtable, Andrew Holden (moderator; Auckland, New Zealand) is joined...
SPYRAL HTN-ON MED study demonstrates meaningful clinical benefits consistent with other SPYRAL HTN renal...
Medtronic has announced the six-month results from the full cohort of the SPYRAL HTN-ON MED clinical trial. The late-breaking data were presented at the...
Vascular News’ top 10 most popular stories of October 2022
Five-year outcomes from the randomised SPACE-2 trial on carotid artery stenosis, an interview with Joseph S Coselli, and a report on the "significant" increase...
BEST-CLI attracts US$3.3m funding injection to continue data analysis
The Novo Nordisk Foundation has made a US$3.3 million contribution toward the BEST-CLI (Best endovascular versus best surgical therapy in patients with critical limb...
SurVeil DCB demonstrates sustained durability of safety, efficacy endpoints in TRANSCEND
In the TRANSCEND clinical trial, the SurVeil drug-coated balloon (DCB; Surmodics) demonstrated "excellent efficacy and safety" out to 24-month follow-up. This is according to...
ABRE clinical study 36-month data show sustained effectiveness of Abre venous self-expanding stent system
Medtronic has announced the 36-month final results from the ABRE clinical study. The purpose of the ABRE clinical study was to evaluate the safety...
Vascular News’ top 10 most popular stories of September 2022
September's top 10 highlights a randomised trial that aims to examine early endovascular aneurysm repair (EVAR) in women, new radiation safety guidelines from the...
TCT 2022 hears “important data” from renal denervation trials
Findings from the RADIANCE II randomised pivotal trial, presented at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT, 16–19 September, Boston, USA), “confirm that ultrasound...
Vascular access creation: EndoAVF keeps future options open, but is not a replacement for...
Based on over four years of experience in a single centre, Robert Shahverdyan (Asklepios Klinik Barmbek, Hamburg, Germany) claims that endovascular arteriovenous fistula (endoAVF)...
EuroPCR 2022: Studies underscore potential of renal denervation as an adjunctive therapy for hypertension
Late-breaking trial data presented at EuroPCR 2022 (17–20 May, Paris, France) underscore the potential of renal denervation as an adjunctive therapy to treat hypertension,...
New sirolimus data provide encouragement despite “potentially disappointing” efficacy results
The results of a small-scale pilot study from Asia have indicated “potentially disappointing” results with a novel drug-eluting balloon in treating dysfunctional arteriovenous access...
First time data release: View the full IN.PACT AV Access trial three-year data presentation...
NOTE: This video is ONLY available to watch in selected countries and geographies
In a late-breaking Podium 1st presentation at the 2022 Charing Cross...
Vascular News’ top 10 most popular stories of April 2022
April's top 10 most popular stories include US Food and Drug Administration (FDA) approval of a frozen elephant trunk (FET) device, as well as...
IN.PACT AV Access: Three-year data support use of paclitaxel-coated balloon as “standard of care”...
The 36-month results from the IN.PACT AV Access study (Medtronic)—which were presented for the first time during at the 2022 Charing Cross (CX) International...
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...
ACC.22: Three-year data show “durable blood pressure reductions” through renal denervation
Long-term data from the first 80 patients in the SPYRAL HTN-ON MED trial have been presented during a featured clinical research session at the...
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...
Vascular News’ top 10 most popular stories of January 2022
Breakthrough designation for a new drug-eluting stent from Cook Medical, a meta-analysis on the safety of expedited carotid artery surgery vs. expedited stenting after...
Jeremy Durack and John Simpson to join Cordis-X innovation accelerator
Ajax Health has announced the appointments of two cardiovascular professionals to Cordis-X, an independent accelerator created to drive innovation and growth to Cordis.
"Since the...
Ellipsys™ Vascular Access System provides consistently great outcomes for AV fistula creation
Alexandros Mallios (Paris, France) and Robert Shahverdyan (Hamburg, Germany) talk to Vascular News about some of the benefits of the Ellipsys™ Vascular Access System...
Vascular News’ top 10 most popular stories of November 2021
November's top 10 features a large-scale analysis of Philips' intravascular ultrasound (IVUS) in lower extremity peripheral vascular interventions, five-year data on Avenu Medical/Medtronic's Ellipsys...
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...
Benefits of percutaneous fistula creation further bolstered by five-year Ellipsys data
The Ellipsys vascular access system (Avenu Medical/Medtronic) can be used to easily and safely create durable percutaneous arteriovenous fistulas (pAVFs) for haemodialysis—with new, long-term...
Episode 4: Real world data show IN.PACT Admiral DCB is “very efficient” even in...
In this penultimate episode of a special five-part series on the history of drug-coated balloons (DCBs), Jos van den Berg (Lugano, Switzerland) is joined...
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),...
IN.PACT AV DCB sustained “superior” effectiveness in subgroups with high reintervention rates out to...
Several subgroups of patients treated with the IN.PACT AV drug-coated balloon (DCB; Medtronic) for arteriovenous fistulas (AVFs) demonstrated a “statistically significant” higher rate of...
Juxtarenal aortic neck challenges session sees unanimous ESAR vote and support for CHEVAR
Thought-provoking presentations, debate and polling during the first day of CX Aortic Vienna 2021 (5–7 October, broadcast) have shed light on important considerations for...
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...
Episode 3: The unique recipe for long-term clinical benefit with IN.PACT™ Admiral™ DCB
In this third episode of a special five-part series on the history of DCBs, Jos van den Berg (Lugano, Switzerland) moderates a Vascular News roundtable discussion...
IN.PACT™ AV Access trial demonstrates “outstanding” patency rates & “significant” advantages through 24 months
Andrew Holden (Auckland, New Zealand) presents the latest results from the IN.PACT™ AV Access trial (Medtronic), which indicate “outstanding” target-lesion primary patency rates of 52.2% through 24...
FDA clears Koya Medical’s Dayspring compression system for lower extremities
Koya Medical announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for...
FDA clears Koya Medical’s Dayspring compression system for lower extremities
Koya Medical announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for...
More mixed results for DCBs in AV access maintenance as evidence mounts
Additional randomised controlled data regarding the effectiveness of drug-coated balloons (DCBs) in maintaining arteriovenous (AV) access offers new evidence, but it is freighted with...
FDA clears Koya Medical’s Dayspring compression system for lower extremities
Koya Medical announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for...
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:...
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,...
Episode 2: Are all peripheral drug-coated balloons created equal?
“Not all Drug-Coated Balloons (DCBs) are created equal”, Juan Granada (New York, USA), tells Vascular News in this second episode of a five-part series on the history of DCBs.
Granada discusses why there...
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,...
Two-year IN.PACT AV Access results presented at CX 2021
Medtronic recently announced the safety and effectiveness results through 24 months for the IN.PACT AV Access clinical study. The data, which were presented virtually...
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...
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,...
“Radiation will be a thing of the past”: FORS in the spotlight at CX...
Opening the Charing Cross (CX) 2021 Digital Edition (19–22 April, online), experts deliberated crucial controversies in the abdominal aortic space. Discussion emphasised the potential...
Vascular News’ top 10 most popular stories of March 2021
Newly-published data on the benefits of a dedicated vascular limb salvage clinic, key product launches in the vascular access space, and evidence to suggest...
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...
‘Indisputable evidence’ that DCB is the “gold standard” for treating vascular access stenosis
NOTE: This video is ONLY available to watch in selected countries and geographies
Tobias Steinke (Düsseldorf, Germany), Matteo Tozzi (Varese, Italy) and Robert Shahverdyan...
Lower-dose SurVeil DCB achieves non-inferiority with IN.PACT Admiral balloon
Kenneth Rosenfield (Boston, USA) speaks to Vascular News about the TRANSCEND trial, a non-inferiority randomised controlled trial, which looked to demonstrate safety and efficacy of the...
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...
COMPARE trial shows low dose DCB is “as safe and efficacious” as high dose...
Sabine Steiner (Leipzig, Germany) talks to Vascular News about the 24-month results from the COMPARE trial – which were presented at LINC 2021 (The...
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...
LINC 2021: Positive first-time data presented for IN.PACT AV DCB and Ellipsys system
New data presented for the first time at LINC 2021 (The Leipzig Interventional Course; 25–29 January, online) support the use of drug-coated balloons (DCBs)...
LINC 2021: Head-to-head trials take centre stage in drug-eluting technology late-breaking session
Data from two head-to-head trials on drug-eluting technologies in femoral artery treatment were presented during a late-breaking session at LINC 2021 (The Leipzig Interventional...
ChEVAR technique essentials: A practical guide to chimney endovascular aneurysm repair
NOTE: This supplement is only available to read in selected countries and geographies
In this supplement, sponsored by Medtronic:
From a bailout procedure to a...
Largest US nephrology group is first in Illinois to offer Ellipsys vascular access technology...
Nephrology Associates of Northern Illinois and Indiana (NANI), the largest nephrology group in the USA, is the first practice in Illinois to adopt the Ellipsys vascular access system (Avenu Medical, now...
IN.PACT™ AV Access trial shows improvement in patency “for the entire fistula”
A trio of vascular experts including Raphaël Coscas (Paris, France), Alexandros Mallios (Paris, France) and Kate Steiner (Stevenage, UK) discuss the key findings of...
Complications of EVAR in 2020: Are they lower than they were a decade ago?
Mo Hamady discusses developments in aortic stent grafts in recent years, and offers a contemplation on the complications associated with endovascular aneurysm repair (EVAR)....
PAVE trial finds “no evidence of a benefit” from paclitaxel-coated balloons in preserving AV...
There is no evidence of a benefit from additional paclitaxel-coated balloon use compared to standard balloon angioplasty alone in the context of preserving arteriovenous...
New England Journal Of Medicine publishes “outstanding” six-month IN.PACT AV Access™ results
NOTE: This video is ONLY available to watch in selected countries and geographies
Robert Lookstein (New York, USA; principal investigator) and Andrew Holden (Auckland,...
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...
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...
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...
Case report shows Ellipsys system creates fused, permanent vascular access for dialysis
A new case report published in the Journal of Vascular Surgery (JVS) provides one of the first known opportunities to directly visualise the anastomosis...
DCB in dialysis access: Do we finally have the right evidence?
NOTE: This supplement is only available to read in selected countries and geographies
In this supplement, sponsored by Medtronic:
Tobias Steinke outlines his treatment algorithm...
“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...
Sac regression with Endurant is associated with decreased risk of all-cause mortality
"Sac regression should be the new paradigm of success after EVAR ," concluded Dittmar Böckler (University of Heidelberg, Heidelberg, Germany) at the European Society...
CX Aortic Vienna addresses juxtarenal issues in the challenging abdominal aneurysm neck
Expert speakers gathered online on the last day of CX Aortic Vienna to discuss juxtarenal issues in the challenging abdominal aneurysm neck, covering topics...
Polling at CX Aortic Vienna shows desire for fragile aorta-specific stent grafts
Use of a specifically designed stent graft to treat a fragile aorta was backed by three quarters of the CX Aortic Vienna audience, polled...
CX Aortic Vienna audience agree sac diameter is of crucial importance in post-EVAR surveillance
During the CX Aortic Vienna sac size and endovascular aneurysm repair (EVAR) follow-up session, polling revealed that 94% of the audience agreed with the...
Ascending aorta: Challenges of obtaining data discussed at CX Aortic Vienna
In the ascending aorta session at CX Aortic Vienna, presentations focused on various treatment options, including frozen elephant trunk (FET) and endovascular intervention. The panellists emphasised the...
Six-month IN.PACT AV Access results published, show superiority of DCB angioplasty
Just-published six-month results of the IN.PACT AV Access study show that drug-coated balloon (DCB) angioplasty is superior to standard angioplasty for the treatment of...
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...
Global SYMPLICITY Registry shows renal denervation lowered blood pressure in patients with hypertension out...
Medtronic has reported new data from the Global SYMPLICITY Registry (GSR), which showed that renal denervation (RDN) with the Medtronic Symplicity renal denervation system...
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...
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 aortic arch discussion highlights importance of underlying pathology and benefit of...
Last week, the CX 2020 LIVE agenda turned to the technically challenging topic of aortic arch interventions. Through presentations, discussion, and polling, the session—chaired...
CX 2020 LIVE gains CME accreditation: Attendees from 79 countries participate live
In a boost for vascular education, the CX 2020 LIVE sessions have been granted European Union (EU) and US reciprocal Continuing Medical Education (CME) points in recognition of its...
Nearly 70% of CX 2020 LIVE global aortic audience finds type II endoleak without...
A global audience tuned into the second session and inaugural aortic offering of CX 2020 LIVE. With registrations now well over 4,000, the pioneering...
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...
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,...
Expanding treatment possibilities in TEVAR
NOTE: This supplement is only available to read in selected countries and geographies
In this supplement, sponsored by Medtronic:
Fabio Verzini discusses his clinical experience...
“Excellent” long-term results after EVAR using Endurant stent graft in 180 AAA patients
Results from a real-world experience over more than 10 years using the Endurant stent graft (Medtronic) demonstrate that it is safe and effective, with...
Real-world data with long-term follow-up confirm no increased mortality signal with paclitaxel-based devices
Data from an unselected, real-world cohort of 64,000 claimants of the German BARMER Health Insurance reveals no signal of increased long-term mortality when paclitaxel-based...
Getinge contributes to ventilator manufacturers group to form Ventilator Training Alliance
Several of the world’s ventilator manufacturers announce a newly formed Ventilator Training Alliance (VTA) to support frontline medical providers to access a centralised repository...
Aortic neck dilation after FEVAR leads to little clinical impact, new mid-term study data...
Data, gathered in a study on the impact of aortic neck dilation after fenestrated endovascular aortic aneurysm repair (FEVAR), show that the process does...
Virtual ACC: Renal denervation bests sham control to safely lower blood pressure in patients...
Three months after undergoing renal denervation, patients with untreated high blood pressure had statistically significant reductions in average blood pressure over 24 hours compared...
Impressions from LINC 2020: Strong clinical and economic case for widespread use of IN.PACT...
NOTE: This video is ONLY available to watch in selected countries and geographies
Andrew Holden (Auckland, New Zealand), Alexandros Mallios (Paris, France), Robert Lookstein (New...
Preliminary experience with LSA branched devices shows promising results
Preliminary experience with left subclavian artery (LSA) branched devices indicates low morbidity and stroke rates with high patency rates. This was the conclusion of...
LINC 2020: Real-world evidence shows no increased mortality signal with paclitaxel-coated device use in...
Dierk Scheinert (Leipzig, Germany) moderates a panel with Eva Freisinger (Münster, Germany) and Thomas Zeller (Bad Krozingen, Germany) to discuss the developments over the...
LINC 2020: Positive new data for AV access interventions released
New arteriovenous (AV) access results were presented at the 2020 Leipzig Interventional Course (LINC; 28–31 January, Leipzig, Germany), including data on percutaneous AV fistula...
LINC 2020: One year IN.PACT AV results show sustained patency benefit for DCB in...
NOTE: This video is ONLY available to watch in selected countries and geographies
The one-year IN.PACT AV trial results, first presented at LINC 2020 (28–31 January, Leipzig,...
VIVA 2019: IN.PACT AV DCB shows “consistent effectiveness performance” in subgroup analysis
Today Medtronic shared a six-month subgroup analysis from the IN.PACT AV Access trial, which evaluated how the IN.PACT AV DCB—an investigational device not currently...
VIVA 2019: Four-year data from the IN.PACT Global study highlight durable performance and safety...
Medtronic today announced four-year data from the IN.PACT Global study, which reinforce the long-term durability and safety of the IN.PACT Admiral drug-coated balloon (DCB)...
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...
A panel of experts comments on IN.PACT AV ACCESS data
NOTE: This video is ONLY available to watch in selected countries and geographies
Jos van den Berg (Lugano, Switzerland) speaks to Andrew Holden (Auckland, New...
CIRSE 2019: IN.PACT AV access trial meets primary safety and effectiveness endpoints
Medtronic has announced the first-ever results from the IN.PACT AV access clinical study comparing the investigational IN.PACT AV drug-coated balloon (DCB) to percutaneous transluminal...
CE mark reinstated for Nellix endovascular aneurysm sealing system
Endologix has announced that the CE mark for the Nellix endovascular aneurysm sealing (EVAS) system has been reinstated. The CE mark for the system...
FDA notifies BD that Lutonix paclitaxel balloon PMA application for below the knee “not...
The US Food and Drug Administration (FDA) have denied BD premarket approval (PMA) for the company’s Lutonix drug-coated balloon (DCB) in the treatment of...
FDA notifies BD that Lutonix paclitaxel balloon PMA request for below the knee “not...
The US Food and Drug Administration (FDA) have denied BD premarket approval (PMA) for the company’s Lutonix drug-coated balloon (DCB) in the treatment of...
Webinar: Safety of paclitaxel devices—What does the evidence say?
Jos van den Berg (Lugano, Switzerland), Antonio Micari (Bergamo, Italy) and Marianne Brodmann (Graz, Austria) sit down after a specially convened US FDA panel...
With CoveredSeal, Valiant Navion™ offers physicians the “best of both worlds” for TEVAR procedures
Paul Hayes (Cambridge, UK), Frank Arko (Charlotte, USA) and Fabio Verzini (Turin, Italy) discuss the Valiant Navion™ (Medtronic) live thoracic endovascular aortic repair (TEVAR)...
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...
EVAR versus open repair: Not bowled OVER by the latest trial results
The OVER trial investigators, led by the late Frank Lederle, recently released the long-term results of endovascular aneurysm repair (EVAR) versus open repair. Janet...
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...
EuroPCR 2019: Renal denervation linked to reduction in subclinical atrial fibrillation
Data presented at EuroPCR today indicates that renal denervation with the Symplicity system (Medtronic) is associated with a reduction in subclinical atrial fibrillation in...
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...
Virtual reality stimulates discussion at CX
For the first time, the audience at the 2019 Charing Cross Symposium (London, UK) was able to experience an array of virtual reality live...
Endoanchors add to therapy options for AAA
Using EndoAnchors to fix and seal endovascular aortic grafts is safe and effective for short-neck abdominal aortic aneurysm (AAA) patients, two-year data from the...
Design of Valiant Navion “improves upon current-generation TEVAR”
In the Aortic Podium 1st session at the 2019 Charing Cross Symposium (CX; 15–18 April, London, UK), Fabio Verzini (Turin, Italy) reported the 30-day...
CX 2019: Evidence supports safety of paclitaxel-coated devices
At the Charing Cross International Symposium, Gary Ansel (Columbus, Ohio) moderates a global panel that includes Thomas Albrecht (Berlin, Germany), Peter Schneider (San Francisco,...
VenaSeal maintains safety and efficacy at extended five-year follow-up
The first-ever 60-month data on Medtronic’s VenaSeal closure system were presented on Tuesday, indicating that at five years, treatment with the cyanoacrylate adhesive for...
Surmodics provides update regarding TRANSCEND clinical trial
Surmodics has announced the company has now resumed patient enrolment into its TRANSCEND clinical trial, and is nearly 75% of the way to its...
Paclitaxel-releasing devices: An unfolding story
Paclitaxel Timeline:
Meta-analysis finds a higher risk of death in the long term when paclitaxel-coated devices are used in the leg
Without additional long-term...
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...
Chimney EVAR rising: Will the technique overcome perceived shortcomings and move to the next...
In this article, Konstantinos P Donas and Frank J Criado review the evidence for endovascular aneurysm repair using the chimney technique, and consider where...
Atherectomy included in pivotal study of QT Vascular’s Chocolate Touch DCB
The FDA has granted approval to include the use of atherectomy for lesion preparation in its ongoing US pivotal study of the Chocolate Touch...
Positive Valiant Captivia five-year outcomes anounced at STS
Medtronic has released new data supporting the long-term durability, safety, and efficacy of the Valiant Captivia thoracic stent graft system for the treatment of...
Patient-level analysis shows no correlation between paclitaxel and mortality—reactions from LINC
Renowned experts expressed confidence in the continued use of paclitaxel-coated devices after independent patient-level data presented at LINC 2019 did not show correlation between...
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...
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...
IN.PACT Admiral DCB three-year results reveal “consistent and durable” treatment
The IN.PACT Admiral drug-coated balloon (DCB; Medtronic) exhibits a consistent and durable treatment effect in “a more complex patient demographic than typically seen in...
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,...
Vascular Dynamics names Martin Rothman chief medical officer
Martin T Rothman has been appointed as chief medical officer of Vascular Dynamics, effective 1 January 2019.
Rothman is a pioneer in interventional cardiology, as...
Patient-level survival analysis demonstrates no link between paclitaxel dose and mortality in patients treated...
New data on the IN.PACT Admiral drug-coated balloon (DCB; Medtronic) in patients with peripheral arterial disease (PAD) in the superficial femoral (SFA) and popliteal...
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...
IN.PACT independent patient-level meta-analysis shows no correlation between paclitaxel exposure and mortality
A renowned panel, moderated by Dierk Scheinert (Leipzig, Germany), comprising Peter Schneider (Honolulu, USA), John Laird (St Helena, USA) and Thomas Zeller (Bad Krozingen,...
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,...
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...
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...
FDA approves Valiant NAVION for inclusion in physician-sponsored IDE
The Valiant NAVION stent graft system (Medtronic) has been approved by the US Food and Drug Administration (FDA) for inclusion in a physician-sponsored investigational...
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...
The resurgence of renal denervation
More than ever before, arterial hypertension represents one of the greatest health threats and challenges for both patients and treating physicians. With the new...
Outcomes of the ANCHOR registry show consistent outcomes for endoanchors at three years
Real-world outcomes in patients from the ANCHOR registry at three years show safe and effective performance of the Heli-FX EndoAnchor system (Medtronic) in complex...
Valiant Navion receives CE mark approval
CE mark approval has been granted for the Valiant Navion thoracic stent graft system (Medtronic) for the minimally invasive repair of all lesions of...
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...
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...
Valiant Navion thoracic stent graft receives FDA approval
The US Food and Drug Administration (FDA) has approved Valiant Navion thoracic stent graft system (Medtronic) for the minimally invasive repair of all lesions...
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...
Cagent Vascular appoints Brian Walsh as chairman of the board
Cagent Vascular, a developer of next-generation angioplasty balloons using proprietary serration technology, announces Brian Walsh to serve as chairman of the Board.
Brian Walsh...
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...
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...
SPYRAL HTN-ON MED study presents initial data on renal denervation system
Medtronic has announced first-ever-data from the SPYRAL HTN-ON MED Study. Initial study results found statistically significant and clinically important blood pressure reductions in hypertensive...
Endospan elects Jeff Elkins as a director
Endospan, a company developing off-the-shelf endovascular repair of Aortic Arch Disease including aneurysms and dissections, has announced that it has elected Jeff Elkins to its board of...
STEP seeks to advance patient safety after TEVAR
Stroke is a major concern following TEVAR (thoracic endovascular aortic repair) and Charing Cross delegates heard the results from a collaborative study that pooled...
IN.PACT Admiral DCB receives FDA approval for long SFA lesions
Medtronic has announced that it has received US Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon (DCB) to treat long superficial...
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....
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...
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...
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:...
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...
LINC 2018 data highlight IN.PACT Admiral as safe and effective treatment option in peripheral...
Medtronic added to its body of clinical evidence supporting the IN.PACT Admiral drug-coated balloon with new presentations that demonstrated durable and consistent clinical outcomes...
ENCHANT will evaluate ChEVAR technique with Endurant II/IIs stent graft system
The post-market, non-interventional, multicentre, non-randomised, single-arm study will enroll approximately 150 patients across 25 sites in Europe and Russia, and will evaluate the safety...
“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...
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...
First patient enrolled in TRANSCEND trial for SurVeil DCB
Surmodics has announced enrolment of the first patient in TRANSCEND, the pivotal clinical trial for the SurVeil drug-coated balloon (DCB). The randomised trial will evaluate...
Endurant II/IIs stent graft receives FDA approval for short neck anatomies with Heli-FX EndoAnchor
Medtronic has received US Food and Drug Administration (FDA) approval for the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm (AAA) patients...
Successful results for Aortica’s AortaFit FEVAR planning software
Benjamin Starnes, chief of Vascular Surgery at the University of Washington (Seattle, USA), has reported successful results for the first 30 patients undergoing fenestrated...
Lombard Medical appoints Jonathan Hornsby as vice president of sales and marketing
Lombard Medical has announced the appointment of Jonathan Hornsby as vice president of sales and marketing, effective immediately.
Jonathan Hornsby brings over 20 years of...
Five-year ENGAGE data demonstrate comparable EVAR outcomes in male and female patients
Five-year data from Medtronic’s ENGAGE global registry indicate that endovascular aneurysm repair (EVAR) outcomes are comparable between male and female patients when using the...
Two- and four-year IN.PACT Admiral drug-coated balloon data indicate good mid- and long-term safety...
Medtronic has released data reinforcing the durability and safety of the IN.PACT Admiral drug-coated balloon (DCB) in patients with peripheral artery disease (PAD). The...
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...
Surmodics receives IDE approval to initiate SurVeil drug-coated balloon pivotal trial
Surmodics has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a pivotal clinical trial of the...
The use of embolic filters to reduce the stroke risk in TEVAR
Richard Gibbs and colleagues have previously demonstrated that 80% of patients undergoing thoracic endovascular aneurysm repair (TEVAR) have evidence of new post-procedural cerebral infarcts by comparing pre-...
IN.PACT Admiral approved for reimbursement in France and Belgium
Medtronic has announced recent reimbursement approvals in both France and Belgium.
A Ministerial decree was published in the Official Journal of French Republic to enlist...
Fabrizio Fanelli: IN.PACT Global study new data
Vascular News interviews Fabrizio Fanelli, Rome, Italy, on the results of the IN.PACT Admiral drug-coated balloon (Medtronic) in long lesions, lesions with calcification, chronic...
Shockwave Medical appoints Doug Godshall as president and chief executive officer
Shockwave Medical has announced the appointment of Doug Godshall as president and chief executive officer.
Godshall was most recently the chief executive officer and a...
Spotlight on non-thermal varicose vein treatments in first-ever CX Venous Edited Cases
For the first time, Day One of this year’s CX Venous Workshop included two edited case presentations (CX Venous Edited Cases). The standing-room only...
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...
Watch and learn: CX Aortic Edited Cases
Tuesday’s CX Aortic Edited Cases session featured exciting and engaging standing-room only case presentations, including Andrew Holden’s (Auckland, New Zealand) first-in-man implantation of the...
Mounting evidence supports increasing use of parallel graft endovascular techniques for select complex aortic...
In a 15-year evolution, parallel graft techniques have emerged as part of the effort to rescue or preserve excluded aortic branches in the context...
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...
Intact Vascular completes enrolment in TOBA II clinical trial
Intact Vascular’s TOBA II (Tack optimized balloon angioplasty II) clinical trial has completed enrolment. A total of 210 patients have been enrolled in TOBA II at 33 sites...
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...
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...
Endovascular treatment in the aortic arch
The development of endovascular stent grafts in the descending aorta has significantly reduced the number of open surgical repairs being performed. However, the ascending...
VeClose trial reports “excellent” clinical and quality of life outcomes at two years
The pivotal VeClose trial is investigating the performance of the VenaSeal cyanoacrylate-based adhesive (Medtronic) for vein closure. At LINC 2017, Vascular News caught up...
TOBA II BTK clinical trial commences enrolment with first implant of Tack Endovascular System
Intact Vascular’s TOBA II BTK (Tack optimised balloon angioplasty II below the knee) clinical trial has commenced enrolment, with the first patient treated by Joseph Cardenas at Yuma Regional Hospital and...
Japanese IN.PACT SFA study demonstrates clinical outcomes consistent with other trials
The one-year clinical outcomes from the MDT-2113 IN.PACT SFA Japan trial have been released. The data was recently presented by Osamu Iida, Kansai Rosai...
VeClose trial indicates 24-month non-inferiority of VenaSeal versus radiofrequency ablation
Two-year outcomes of the VeClose pivotal trial have been reported, showing a 94.3% closure rate and “continued non-inferiority results to radiofrequency ablation” when using...
Scott Hutton appointed general manager of Vascular Intervention at Spectranetics
Scott Hutton has been named general manager of Vascular Intervention at Spectranetics.
In this role, Hutton will report directly to the president and chief executive...
Comparison of EVAR 1 and ENGAGE data shows the evolution of EVAR
The EVAR 1 trial—investigating the efficacy of endovascular aneurysm repair (EVAR) versus open repair—and the ENGAGE registry—examining the performance of the Endurant (Medtronic) stent...
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...
VEITH 2016: New data support strength and durability of Endurant II/IIs stent graft
Medtronic announced data supporting the strength and durability of the Endurant II/IIs stent graft system to treat abdominal aortic aneurysm patients. The results, presented...
Valiant Captivia stent graft shows 90% freedom from dissection-related mortality at three years
The Valiant Captivia thoracic stent graft system (Medtronic) has demonstrated freedom from all-cause mortality of 79.4% and freedom from dissection-related mortality of 90% at...
Device developments in EVAR: What we learned from the past; what we need for...
The introduction of endovascular grafts for treatment of abdominal aortic aneurysms represents the major determinant for the endovascular revolution of the last 25 years....
PQ Bypass announces Peter Wehrly as president and CEO
PQ Bypass, a medical technology company pioneering a fully percutaneous approach to femoral-popliteal bypass surgery, announced on 14 September 2016 the addition of several...
US FDA approves first drug-coated balloon for treatment of in-stent restenosis
The US Food and Drug Administration (FDA) has approved Medtronic’s IN.PACT Admiral drug-coated balloon as a treatment for in-stent restenosis in patients with peripheral...
Any instructions for use non-adherence predicts graft-related adverse events in elective EVAR patients
Frequently, instructions for use (IFU) parameters published by device manufacturers are not adhered to in order to increase patient candidacy for endovascular aneurysm repair...
WAVES trial shows 100% vein closure at one month with short return to work...
A post-market evaluation of the VenaSeal closure system (Medtronic) has found that, at one month, 100% of treated veins remained closed, quality of life...
US FDA approves study of Sanford Health Unitary Manifold stent graft system
Sanford Vascular Innovations, a division of Sanford Health, has receive US Food and Drug Administration approval to study the Unitary Manifold stent graft system...
Plain balloon angioplasty remains a useful adjunct to drug-coated balloons for SFA disease
Despite improved outcomes in recent drug-coated balloon trials, standard balloons still have an important and complementary role to play in treating superficial femoral artery...
Key clinical questions I would like to see answered in the future of deep...
Therapies in deep venous thrombosis (DVT) have been slow to advance over the past 50 years. Recently, growing awareness and improvements in tools and...
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...
When and how to treat type B dissections
The use of endovascular repair for uncomplicated type B dissections is still a controversial topic, with no consensus amongst vascular specialists. Vascular News spoke...
The use of Drug-Coated Balloons in AV ACCESS (OUS only)
This educational supplement highlights the use of the IN.PACT Drug-Coated Balloon for the treatment of dysfunctional dialysis access, presents a best practice algorithm for...
VenaSeal closure system demonstrates long-term durability and improved quality of life in venous reflux...
At the 2016 Charing Cross Symposium (26–29 April, London, UK) and the International Vein Congress (28–30 April, Miami, USA) Medtronic unveiled clinical data for...
Presentation compares ENGAGE Global Registry with landmark EVAR 1 trial results
A presentation at the Abdominal Aortic Aneurysm Challenges session during the 2016 Charing Cross Symposium (26–29 April, London, UK) has compared the ENGAGE global registry...
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...
First two fenestrated EVAR procedures performed with the Aortica AortaFit system
Two cases have been successfully completed using the AorFit (Aortica) system to support simplified fenestrated endovascular aneurysm repair (FEVAR). The surgeries were performed by...
First patient treated with Valiant thoracoabdominal aortic aneurysm stent graft in clinical study
The procedure was performed by Patrick Kelly, Sanford Health, through a physician-sponsored, investigational device exemption, approved by the US Food and Drug Administration
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....
InnAVasc appoints Joseph Knight as new president
Joseph Knight has been appointed president of InnAVasc.
“We are pleased to announce Joe’s appointment as resident,” says Jeffrey Lawson, chief executive officer of InnAVasc....
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...
Valiant Captiva thoracic stent graft shows encouraging two-year results in treating type B aortic...
The Valiant Captiva (Medtronic) thoracic stent graft has demonstrated positive outcomes at two years when used to treat acute complicated type B aortic dissections....
VenaSeal closure system launched in the USA
Medtronic’s VenaSeal closure system has been granted pre-market approval (PMA) from the US Food and Drug Administration (FDA) for the treatment of symptomatic venous...
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...
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)...
When and how to use chemical and mechanical barriers for in-stent restenosis
In-stent restenosis patients with severe claudication or critical limb ischaemia should be treated with drug-coated technologies if they present with focal lesions and with...
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...
Entrust delivery system launched in the United States
According to Medtronic, the new system provides an easy to use, accurate and controlled, one-handed stent delivery system when treating patients with peripheral arterial disease.
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.
VenaSeal demonstrates 96.8% closure rate in the treatment of incompetent greater saphenous veins
The 12-month closure rates for Medtronic's VenaSeal closure system are comparable to those achieved using radiofrequency ablation.
Cyanoacrylate embolisation agent non-inferior to radiofrequency ablation for incompetent great saphenous veins treatment
Twelve-month results from the VeClose trial have demonstrated cyanoacrylate adhesive (CAE) is non-inferior to radiofrequency ablation (RFA) for the treatment of incompetent great saphenous veins.
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.
Companies announce new round of renal denervation randomised trials
Medtronic has announced the initiation of the SPYRAL HTN clinical trial programme studying renal denervation in uncontrolled hypertension, and Boston Scientific has announced the initiation of the REDUCE-HTN: REINFORCE, studying the Vessix renal denervation system.
Silk Road Medical appoints Andrew Davis as executive vice president of global sales
Davis will lead the company's commercialisation efforts for the transcarotid artery revascularisation procedure with the Enroute transcarotid neuroprotection system and Enroute transcarotid stent 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.
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.
BEST-CLI to shed light on top practices for critical limb ischaemia
In September 2014, the BEST-CLI (Best endovascular vs. best surgical therapy in patients with critical limb ischemia) trial started enrolling patients in North America....
UK risk score for EVAR complications may benefit international patients
A study published in the British Journal of Surgery has provided international validation of the St George's Vascular Institute risk score, developed to predict the risk of complications in patients undergoing EVAR.
Prot̩g̩ GPS stent receives FDA approval for the treatment of iliac artery stenosis
The news on the approval of the device from Medtronic follows the nine-month results of the DURABILITY Iliac study, which were presented in November 2014 and showed a 95.8% nine-month primary patency rate.
Cardiva Medical appoints John Russell as president and chief executive officer
Russell succeeds Charles Maroney, who has served as chief executive officer since June, 2010 and who will remain in his role as member of the Cardiva board of directors.
FDA approves VenaSeal closure system to permanently treat varicose veins
The Medtronic VenaSeal system is intended for patients with symptomatic superficial varicose veins of the legs.
FDA classifies Covidien field action for Trellis-6 and Trellis-8 systems as a Class 1...
Medtronic announced today that a previously communicated global voluntary recall to address an issue with certain lots of its Trellis-6 and Trellis-8 peripheral infusion...
Vascular Flow appoints new chief clinical officer
Barbara Bunger has previously led clinical trial operations for Medtronic and developed clinical, regulatory and quality strategies for Si-Bone.
Spectranetics completes acquisition of Stellarex drug-coated balloon assets from Covidien
Spectranetics has now launched the product in Europe, with US commercialisation anticipated in the 2017 timeframe, following US Food and Drug Administration approval.
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...
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.
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...
Spectranetics to acquire Covidien’s Stellarex drug-coated balloon
The Spectranetics corporation and Covidien have announced a definitive agreement under which Spectranetics will acquire Covidien's Stellarex drug-coated angioplasty balloon platform for US$30m.
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...
CryoLife appoints Pat Mackin as president and chief executive officer
CryoLife has announced that its Board of Directors has appointed James Patrick (Pat) Mackin, age 47, as president and chief executive officer, effective September 2, 2014.
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.
Advancing evidence-based medicine in the aorta
Vascular News interviewed international EVAR and TEVAR thought-leaders to gain their perspectives on evidence-based aortic intervention. The interviews show that long-term clinical evidence from...
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...
Sustained reduction in target lesion revascularisation with In.Pact Pacific drug-coated balloon
Data presented at the Leipzig Interventional Course show the reduction in target lesion revascularisation and major adverse events observed with In.Pact Pacific drug-coated balloon (Medtronic) in the PACIFIER study is sustained at two years.
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...
Renal denervation during surgery for aortic aneurysms and occlusive disease
By Juan Parodi
Hypertension is one of the most prevalent diseases in the world and represents a major cardiovascular risk factor. Sympathetic nerves of the...
First patients randomised in SYMPLICITY HTN-4 study for patients with moderate uncontrolled hypertension
Medtronic's second randomised renal denervation trial in the USA will potentially expand access to the Symplicity renal denervation system for even larger uncontrolled hypertension patient population.
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.
ENGAGE registry shows low complication rates with Endurant II at three years
Results from the study also show 90.7% freedom from secondary endovascular procedures and 98.4% freedom from aneurysm-related mortality with the EVAR device from Medtronic.
Valiant Mona LSA stent graft system demonstrates proof of concept in early feasibility study
Presented at the VEITHsymposium, acute results from initial trial of new medical technology show promise for endovascular approach to thoracic aortic aneurysms involving left subclavian artery.
FDA approves Complete SE Vascular Stent for use in the superficial femoral and proximal...
Medtronic announces that the US Food and Drug Administration (FDA) has approved the Complete SE (self-expanding) vascular stent for use in the lower extremities, specifically in the superficial femoral artery and proximal popliteal artery.
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.
New Pacific Plus peripheral angioplasty balloon gets FDA clearance and the CE mark
The balloon, from Medtronic, is indicated for the treatment of narrowed arteries in a variety of locations within the vasculature, including the renal, iliac, iliofemoral, femoral, popliteal and infrapopliteal arteries.
First-in-man implantation of left subclavian artery branched TEVAR device conducted in the USA
The procedure with the new Valiant Mosa LSA Stent Graft System is part of a feasibility trial taking place at Carolinas HealthCare System's Sanger Heart & Vascular Institute and Cleveland Clinic and occurred two days after a presentation about the device at CX35.
Endurant stent graft shows sustained durability in complex patients
Analysis of ENGAGE registry found similarly strong outcomes with device for endovascular treatment of abdominal aortic aneurysms in short and standard neck lengths.
Thoracic-length Heli-FX aortic securement system receives the CE mark
Similar to the system that was cleared in May 2011 and designed for treating abdominal aortic aneurysms, the new system consists of a longer delivery device with additional tip configurations to bring the helical EndoAnchor technology to the treatment of thoracic aneurysms.
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.
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.
Drug-eluting balloons are an emerging strategy for carotid in-stent restenosis
Two studies published in the Journal of Endovascular Therapy have concluded that the use of drug-eluting balloons to treat in-stent restenosis after carotid artery stenting shows promising preliminary results.
FDA approves Valiant Captivia stent graft for aortic transection repair
Results from the RESCUE trial, to be presented at the upcoming VEITHsymposium, supported the new FDA indication approval for thoracic aortic transections.
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.
FDA clears HeliFX Aortic Securement System for thoracic endovascular aneurysm repair
Similar to the original HeliFX system (Aptus Endosystems) that was cleared in November 2011 and designed for treating abdominal aortic aneurysms, the new system consists of a longer delivery device with additional tip configurations for the treatment of thoracic aortic aneurysms.
Endurant abdominal aortic aneurysm stent graft shows durable performance at two years in US...
The study found that nearly all (97.6%) of the aneurysm sacs that were treated with the Endurant AAA stent graft decreased or remained stable in size at two years post-procedure, with only 0.8% type I endoleaks and no type III endoleaks.
Aptus Endosystems initiates the ANCHOR post-market registry
ANCHOR is a global, multicentre, prospective post-market registry, which will evaluate the use of the HeliFX Aortic Securement System (Aptus Endosystems) in the treatment of abdominal aortic aneurysms.
Two new clinical studies to evaluate the Symplicity renal denervation system for different conditions
The studies, sponsored by Medtronic, are the Global SYMPLICITY patient registry which is set to evaluate the real-world, long-term impact of renal denervation in more than 5,000 patients and the SYMPLICITY-HF which is the first clinical trial to examine renal denervation in patients with chronic heart failure and renal impairment.
Endurant II abdominal aortic aneurysm stent graft system gets CE mark
"The Endurant II AAA stent graft system (Medtronic) will confer considerable confidence to vascular surgeons who use EVAR to treat even the most complex abdominal aortic aneurysms," said Hence Verhagen, chief of vascular surgery at the Erasmus Medical Center in Rotterdam, The Netherlands.
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.
Aptus receives FDA clearance for EndoStapling system
The HeliFX system from Aptus Endosystems provides physicians with a novel technology to repair endovascular grafts that have migrated away from the implant site, have developed endoleaks or are at risk of developing these complications, which are commonly seen after EVAR.
First patient enrolled in the post-approval US study of the Endurant stent graft system
ENGAGE PAS is a prospective, multicentre, single-arm study designed to demonstrate the long-term safety and effectiveness of the Endurant stent graft (Medtronic) for the treatment of abdominal aortic aneurysms in a post-market environment.
VALOR II study highlights strengths of Valiant Thoracic Stent Graft
Medical device shows strong safety and efficacy in treatment of thoracic aortic aneurysms through one-year of patient follow-up in US clinical study.
Is current carotid stent design inadequate?
At CX33, there was a debate on the motion "Current carotid stent design is inadequate and contributes significantly to procedure-related stroke." Sumaira Macdonald, Newcastle, UK, spoke for the motion and William Gray, New York, USA, against.
Endurant receives FDA approval
The device showed no post-implant aneurysm ruptures or aneurysm-related deaths through one year of patient follow-up in the US clinical trial.
“Encouraging” results with the Endurant stent graft in US trial at one year
Definitive results from IDE study demonstrate durable safety and effectiveness of implantable medical device for minimally invasive treatment of abdominal aortic aneurysms.
One-month data show early safety and effectiveness with the Valiant thoracic stent graft
Initial results from US study demonstrate early safety and effectiveness of the Medtronic device for minimally invasive treatment of thoracic aortic aneurysms.
New retail partner joins fight against abdominal aortic aneurysms
US pharmacy chain will join Find the AAAnswers campaign to support free education, risk assessment and screening for vascular disease affecting more than 1 million Americans.
Aneurysm sac shrinkage greater with fenestrated grafts
A comparison of endovascular aneurysm repair of abdominal aortic aneurysms with suprarenal fixation devices or fenestrated devices showed no difference in terms of survival and re-intervention rates.
Europe set for wave of next generation EVAR devices
Endurant, Zenith LP, Excluder C3 and Incraft amongst devices that expand the stent graft market.
Jan Blankensteijn
Jan Blankensteijn, Division of Vascular Surgery, VU Medical Center, Amsterdam, The Netherlands, and principal investigator of the DREAM trial, has EVAR as his first...
First patient treated with Valiant Thoracic Stent Graft in aortic dissection trial
Minimally invasive procedure with the Medtronic device may stabilise bleeding and improve clinical outcomes.
Talent stent graft shows durable performance in patients with abdominal aortic aneurysms
Five-year results from US clinical trial presented at Vascular Annual Meeting showed freedom from major adverse events at 30 days was 89.2% in the Talent group.
Post-market study announced for Talent thoracic stent graft
Medtronic launch THRIVE study to assess aneurysm-related mortality at five years
Talent thoracic stent graft launches in Japan
Medical device expands patient access to minimally-invasive treatment for aortic aneurysms
CX 31- Van Herzeele calls for simulation-based endovascular skills training first
Virtual reality simulation, one of the new courses at this year's Charing Cross Symposium, is a valuable training tool which could lower errors and costs in real life.
Thoracic challenges: dissection and aneurysms
Each year 50,000 patients are diagnosed with lesions of the thoracic aorta in Europe
Quo Vadis endovascular abdominal aortic aneurysm repair?
Editorial: Roger Greenhalgh
Critical issues in endovascular stent grafting
11th international symposium concerning 'Critical Issues in endovascular stent grafting', took place in Groningen, The Netherlands, 2007.
CX 30th ‘Vascular and Endovascular Consensus Update’
The 30th Charing Cross International Symposium will take place at Imperial College, London, UK, from April 12th to 15th 2008.
Uncertainty remains following mid-term INSTEAD results
Dr Mike Dake presented Neinaber's results oon his behalf at the Charing Cross meeting.
Cook reveals aneurysm market results for 2006
Barry Thomas from Cook Medical's Aortic Intervention Division, presented an overview of the global market events relating to abdominal aortic aneurysm (AAA) stent grafts.
VALOR II and VIRTUE to evaluate Valiant system
"The Valiant stent graft has quickly become the most widely used thoracic graft outside the United States..."
Symptomatic patients should be treated with closed cell stents
Dr Marc Bosiers discusses whether device characteristics affect outcomes in carotid artery stenting
EVC 2006: Expanding endovascular indications
At this year's meeting were many challenging questions including - what evidence is there for endovascular treatment'?
MasterClass discusses the management of thoracic aortic disease
The event was again organised by Peter Taylor and John Reidy of Guy's and St Thomas' NHS Foundation Trust, London, UK.
Study to assess stenting vs medical treatment in acute Type B dissections
Study investigates mortality and the re-intervention rate due to dissection related disease
Lifeline challenges EVAR 2 outcomes
AHRQ Review
Boston-Guidant story draws to close
New entity is the world's third largest medical device company
VALOR high-risk arm reveals highly-favorable outcomes
Medtronic Vascular Talent Thoracic Stent Graft System
Global Endovascular Forum
New techniques, technologies and horizons
Towards Vascular and Endovascular Consensus
at Charing Cross
Battle for Guidant continues to rage
The battle between Johnson & Johnson and Boston Scientific
What future for carotid stenting?
Annual meeting of the Vascular Society
Guidant sues Johnson & Johnson to complete merger
Largest in the healthcare industry
EUROSTAR Registry hailed at ESVS
Guest speakers concluded that the Registry had provided the vascular community with many valuable lessons
INSTEAD study for type B aortic dissection completes enrolment
136 patients with type B aortic dissections
Thoracic aortic dissection at 2005 Thoracic Masterclass
Vascular News attended the recent Masterclass V
Graft designs hot topic at Critical Issues Symposium
The latest issues surrounding endovascular aortic repair and carotid stenting
Latest from VALOR trial
Presented at Charing Cross by Dr Ron Fairman
New endograft study validates emergency endovascular repair
The results from the New ERA Study
US Thoracic Market set to explode
At the moment the market for Thoracic grafts appears ready to expand significantly in the US
Towards Vascular and Endovascular Consensus at Charing Cross
Over 1,500 people from 60 countries attended the 27th Charing Cross International Symposium
Clinical trial updates at Charing Cross
Including SIROCCO II, ASTRAL, MAVEric, SAPPHIRE and MIMIC
Profile: Ken Ouriel
Vascular News talks to Dr Kenneth Ouriel
Charing Cross goes from strength to strength
Last year's Charing Cross International Symposium reached new heights
Johnson & Johnson to buy Guidant for $25.4bn
Johnson & Johnson announced an agreement to buy Guidant
Big push to get SAAAVE Bill passed
Screen Abdominal Aortic Aneurysms Very Efficiently
Exciting times for the British Vascular Foundation
The BVF will continue to operate much as it has done before but under the auspices of the Vascular Society.
The 7th International Symposium on Critical Issues in Endovascular Grafting
The most important European meeting of the year for aortic endografting
The impact of drug-eluting stents
Coronary vascular stenting is expected to go through a massive change over the next few years with drug-eluting stents replacing bare-wire stents and non drug-coated stents.
