W.L. Gore & Associates said today it won FDA premarket approval for its Tigris self-expanding vascular stent designed for treating peripheral artery disease. The 3rd-generation dual-component stent features a combination of flexible fluoropolymer and single-wire nitinol and is designed to conform to the natural movement of the knee, the Newark, Del.-based company said. “At Gore, […]
W.L. Gore & Associates
Gore touts Viabahn endoprosthesis superiority over PTA in new study
W.L. Gore & Associates today released results from a clinical study of its Viabahn endoprosthesis in AV access graft outflow interventions, touting a 50% increase over percutaneous transluminal angioplasty alone in target lesion primary patency at 6 months. The company reported that treatment with the Viabahn resulted in significantly better outcomes when compared against PTA […]
Gore wins CE Mark for Excluder stent graft
W.L. Gore & Associates said today it won CE Mark approval in the European Union for its Excluder conformable device designed to treat abdominal aortic aneurysms in patients with challenging anatomies. The newly cleared Excluder device won approval for patients with either proximal aortic neck angles of up to 90 degrees or a minimum aortic […]
Gore touts 1st implant of Synecor in CQI trial
W.L. Gore & Associates said today its Synecor biomaterial designed for hernia repair was used in the 1st procedure of its clinical quality improvement project. The robotically assisted surgical procedure was performed at the Our Lady of the Lake hospital in Baton Rouge, La. by Dr. Karl LeBlanc, the Newark, Del.-based company said. “I think that […]
Gore wins Health Canada approval for Excluder stent graft
W.L. Gore & Associates said today it won Health Canada approval for its Excluder iliac branch endoprosthesis designed for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The IBE device is designed to be used in conjunction with Gore’s Excluder AAA endoprosthesis for treating abdominal aortic aneurisms. The Excluder device is designed […]
Gore launches new type of study for Synecor hernia biomaterial
W.L. Gore & Associates said today it is launching a clinical quality improvement project to study its Synecor biomaterial designed for open, laparoscopic and robotic single-stage hernia repairs. The Synecor biomaterial is comprised of dense monofilament polytetrafluoroethylene macroporous knit to provide strength and reduce bacteria growth, Gore’s Bio-A Web tissue scaffold and a non-porous PGA/TMC […]
Gore wins FDA nod for Excluder stent graft
W.L. Gore & Assoc. said today that it won FDA approval for its Excluder stent graft for treating abdominal aortic aneurisms. The Excluder device is designed to treat aneurysms in the iliac arteries as they branch off from the aorta. The approval, announced at the Houston Aortic Symposium, makes Gore the 1st company on the U.S. market […]
Gore wins 510(k) for Synecore hernia repair biomaterial
W.L. Gore & Associates said today it won FDA 510(k) clearance for its Synecor biomaterial designed for open, laparoscopic and robotic single-stage hernia repairs. The Synecor biomaterial is comprised of dense monofilament polytetrafluoroethylene macroporous knit to provide strength and reduce bacteria growth, Gore’s Bio-A Web tissue scaffold and a non-porous PGA/TMC film to minimize tissue […]
Gore touts bioabsorbable hernia mesh study data
W.L. Gore & Associates today released data from a long-term study of its Gore Bio-A tissue reinforcement bioabsorbable mesh designed to treat complex ventral hernias in patients with contaminated fields. The study was published in the Annals of Surgery. Gore’s Bio-A is designed as a web of biocompatible synthetic polymers that are gradually reabsorbed into […]
PAD: Gore launches post-approval study of Viabahn stent graft
W.L. Gore & Associates said this week that it launched a post-approval study of its Viabahn stent graft for treating peripheral artery disease. The 108-patient Reline Max study will examine the treatment of in-stent restenosis in the superficial femoral artery using the Viabahn device, which is designed to inhibit blood clots with its heparin coating. The Viabahn […]
Gore wins round in stent graft bout with Bard
W.L. Gore & Associates won a round against C.R. Bard (NYSE:BCR) in an ongoing stent graft patent validity battle as a Delaware federal judge upheld the validity of 2 Gore stent graft patents. The court ruled that Gore’s patent on stent graft devices in tubes less than 0.1 millimeter was valid, rejecting Bard’s invalidity argument, […]