W.L. Gore & Associates said today it won Health Canada approval for its Tigris dual-component vascular stent designed to treat 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, […]
Gore must cough up fees to cover pursuit of sanctions in stent graft spat with Bard
A federal judge in Delaware yesterday ordered W.L. Gore & Assoc. to cough up some of the legal fees C.R. Bard (NYSE:BCR) incurred in defending itself against Gore’s bid for sanctions against Bard’s lawyers in their long-running war over stent graft patents. Gore alleged that the Bard legal time conspired to sit on an expert witness report […]
FDA approves Gore’s Viabahn VBX stent graft for iliac artery lesions
W.L. Gore & Assoc. said today that it won FDA approval for its Viabahn VBX stent graft for treating iliac artery lesions, including those found at the aortic bifurcation. Flagstaff, Ariz.-based Gore said the approval means the device is the only balloon-expandable stent graft indicated for the iliac artery. “The VBX stent graft combines radial strength with trackability […]
Veith 2016 Roundup: Stent grafts take center stage
Medtronic touts Endurant stent graft data from Engage study Medtronic (NYSE:MDT) touted data from a series of sub-group analyses from the 10-year 1,200-patient Engage study of its Endurant II and Endurant IIs stent grafts for treating abdominal aortic aneurysms last week at the annual Veith Symposium on vascular disease. First-time results from a review of […]
Gore wins Medicare add-on status for Excluder stent graft
W.L. Gore & Assoc. said today that it won new technology status from the U.S. Centers for Medicare & Medicaid Services for its Gore Excluder iliac branch endoprosthesis. Set to go into effect Oct. 1, the change will allow facilities that use the device, in conjunction with Gore’s Excluder AAA device for endovascular aneurysm repair, to be eligible […]
Gore touts 1-year data from Japanese study of Viabahn stent graft
W.L. Gore & Associates yesterday released 1-year data from a Japanese study of its Viabahn stent graft, touting a nearly 90% primary patency rate at 12 months. Data comes from a 103-patient single-arm study which enrolled a “challenging patient population” with lesions greater than 10cm, Newark, Del.-based Gore said. “Eighty-eight percent is an extremely high […]
Gore launches trial for Tag thoracic branch endoprosthesis
W.L. Gore & Assoc. said today that it enrolled the 1st patient in a pivotal study evaluating its Tag thoracic branch endoprosthesis as a treatment for lesions of the aortic branch and descending thoracic aorta. The Tag TBE is the 1st Gore device to win the FDA’s expedited access pathway designation and among the 1st medical devices […]
Gore launches DrySeal Flex introducer sheath
W.L. Gore & Associates said today it is launching its DrySeal Flex introducer sheath designed for use with its Gore Excluder iliac branch endoprosthesis device, which is used for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The newly-launched device is designed with improved flexibility, kink resistance and a hydrophilic coating to […]
Gore wins FDA nod for Tigris vascular stent
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, […]
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 […]
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