BD announced today that it enrolled the first patient in a trial of its Vascular Covered Stent for treating peripheral arterial disease (PAD). Franklin Lakes, New Jersey–based BD is evaluating the safety and effectiveness of the stent in its AGILITY FDA investigational device exemption (IDE) trial. The self-expanding, low-profile, polytetrafluoroethylene encapsulated nitinol implant is deployed […]
Stent Grafts
Medtronic, Rijnstate enroll first patient in aneurysm repair trial
Medtronic , with Rijnstate, announced today that they enrolled the first patient in the Hercules trial comparing abdominal aortic aneurysm repair methods. Hercules compares endosuture aneurysm repair (ESAR) to standard endovascular aneurysm repair (EVAR). It looks at these methods in patients who have an abdominal aortic aneurysm (AAA) with a wide, infrarenal neck diameter. Abdominal aortic aneurysms […]
FDA approves Gore low-profile balloon-expandable endoprosthesis
W.L. Gore & Associates announced today that it received FDA approval for a lower-profile Viabahn VBX balloon-expandable endoprosthesis. FDA approval builds on the company’s proven VBX stent graft for treating complex vascular disease. The company says it offers the longest balloon-expandable stent on the market (79 mm) and the widest range of stent diameter adjustability. […]
Gore enrolls first patients in expandable stent graft trial
W.L. Gore & Associates announced today that it enrolled the first patients in a trial evaluating its Viabahn VBX stent graft. The study compares Gore’s balloon-expandable endoprosthesis to bare metal stenting for patients with complex iliac occlusive disease. It aims to inform practice guidelines around the best modalities suited for patients with this condition. Dr. […]
BD enrolls first patient in study of stent graft for treating portal hypertension
BD (NYSE:BDX) announced today that it completed the enrollment of the first patient in a trial of its Liverty TIPS stent graft. Franklin Lakes, New Jersey-based BD’s ARCH FDA investigational device exemption (IDE) study evaluates the safety and effectiveness of Liverty. The global, prospective, multi-center, single-arm clinical study looks at the investigational device in the […]
Cook Medical gets FDA nod for endovascular graft trial for treating aortic aneurysm
Cook Medical received FDA approval to initiate an investigational device exemption (IDE) study for an aortic aneurysm treatment. The study will evaluate the Zenith Fenestrated + Endovascular Graft (ZFEN+). It assesses the safety and effectiveness of ZFEN+ in combination with Bentley’s InnoMed BeGraft balloon-expandable Fevar bridging stent graft system. The companies aim to look at […]
Gore initiates study to compare VBX stent graft, metal stenting
Gore announced today that it initiated a clinical study comparing its VBX stent graft to bare metal stenting. The FORWARD study evaluates the methods in the treatment of complex iliac occlusive disease. Gore’s prospective, multicenter, randomized controlled trial includes up to 40 sites in the U.S., Australia, New Zealand and Europe. The company estimates a […]
10-year data shows durable outcomes with Medtronic Endurant stent graft system
Medtronic (NYSE:MDT) today announced positive results from its 10-year post-market registry for the Endurant stent graft. The Endurant stent graft system offers Endovascular aneurysm repair (EVAR) to treat patients with abdominal aortic aneurysm (AAA). Medtronic posted the real-world data at the 2023 Charing Cross Symposium in London, marking the completion of the study. Dr. Hence […]
Medtronic enrolls first patient in head-to-head aortic stent graft trial with Gore Medical
Medtronic (NYSE:MDT) today announced that it enrolled the first patient in a head-to-head trial of aortic stent graft systems. The Advance trial evaluates the Medtronic Endurant II/IIs and the Gore Excluder AAA device family. Medtronic said in a news release that it expects to enroll 550 patients at up to 50 global centers in the […]
Endologix wins CE mark for abdominal aortic aneurysm system
Endologix announced today that it received CE mark approval for its AFX2 endovascular abdominal aortic aneurysm (AAA) system. Irvine, California-based Endologix designed the AFX2 system with unique sealing technology that preserves native bifurcation to provide durable outcomes and personalized repair for AAA patients. “CE Mark certification under the new [EU MDR] requirements is a high-bar […]
Ariste Medical co-founder sees great potential for drug-coated implants and orthopedics
It’s been more than a decade since Lisa Jennings launched not one but two companies in the Great Recession. In 2020, she sold CirQuest Labs to MLM Medical Labs, where Jennings serves as chief scientific officer and managing director of U.S. operations. More recently, her pre-commercial medtech development startup, Ariste Medical, won FDA 510(k) approval for […]