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 […]
Stent Grafts
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 […]
Endologix launches Alto abdominal stent graft in Canada
Endologix (NSDQ:ELGX) today said it launched its Alto abdominal stent graft in Canada following its recent Health Canada approval. The Alto abdominal stent graft system is a polymer-based therapy for abdominal aortic aneurysm (AAA) patients. It uses a low-profile delivery system with a conformable sealing ring that molds in-situ to the patient’s specific aortic neck anatomy. […]
Medtronic stent graft recall is serious
The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent graft system as Class I, the most serious kind. Medtronic’s Valiant Navion is designed to repair lesions of the descending thoracic aorta, using a long catheter to place the stent graft inside the aorta before it expands to fit within the aorta to […]
Medtronic issues voluntary recall of Valiant Navion thoracic stent graft system
Medtronic (NYSE:MDT) announced today that it issued a voluntary recall of unused Valiant Navion thoracic stent graft systems. Fridley, Minn.-based Medtronic’s global recall included informing physicians to immediately cease use of the device until further notice, according to a news release. The company initiated the recall in response to information it recently obtained from the Valiant […]
Endologix files for bankruptcy, will go private
Endologix (NSDQ:ELGX) announced today that it has filed for Chapter 11 bankruptcy protection and simultaneously agreed to be purchased by its largest creditor. That creditor, Deerfield Partners, will take the Irvine, Calif.-based abdominal aortic aneurysm (AAA) stent graft developer private. The bankruptcy filing and sale “provide the best path to address the financial challenges resulting from […]
