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 […]
Stent Grafts
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 […]
Lombard Medical exits U.S. market, shares jump
Lombard Medical Technologies (NSDQ:EVAR) said yesterday that it’s bailing out of the U.S. market after an FDA decision requiring a 50-patient clinical study of its Intelliflex low-profile delivery system for the Aorfix stent graft. Lombard said it eliminated its U.S. sales force and moved most of its commercial operations to its U.K. facility, significantly reducing its cash burn. Irvine, […]
Medtronic touts 5-year Endurant stent graft data
More than 5 years after Medtronic‘s (NYSE:MDT) Endurant Stent Graft System 1st gained FDA approval, the medical device giant has released data pointing to long-term durability of the treatment for abdominal aortic aneurisms. Healio reported that Endurant showed durability and safety in patients 5 years after treatment, according to details published in the Journal of Vascular Surgery. […]
Abbott wins FDA nod for Absorb stent
Abbott (NYSE:ABT) said today it won FDA premarket approval for its Absorb bioresorbable everolimus eluting heart stent, touting it as the 1st fully dissolving stent approved for treating coronary artery disease. The newly cleared stent is designed to dissolve completely after approximately 3 years after serving to keep clogged arteries open and promote healing in […]
Lombard touts 1st commercial use of IntelliFlex LP with Aorfix stent graft
Lombard Medical Technologies (NSDQ:EVAR) today touted the 1st commercial use of its IntelliFlex low profile delivery system designed to implant the Aorfix endovascular stent graft in a procedure to treat an abdominal aortic aneurysm. The procedure was performed by Dr. Nilo Mosquera at Spain’s Complexo Hospitalario Universitario de Ourense on the 28th of June, the Irvine, […]
Lombard Medical wins CE Mark for Aorfix AAA stent graft delivery device
Lombard Medical Technologies (NSDQ:EVAR) said today it won CE Mark approval in the European Union for its IntelliFlex low profile delivery system for its Aorfix endovascular stent graft. The system is designed for the delivery of the company’s abdominal aortic aneurysm Aorfix endovascular stent graft, and includes an integrated exchange sheath designed for the delivery of […]
EuroPCR 2016 Update: TAVR innovations, FFR systems in the spotlight
UPDATED May 20, 2016, with more results out of Paris. St. Jude Medical (NYSE:STJ) announced it won CE Mark approval in the European Union for its PressureWire X Guidewire fractional flow reserve measurement system and is launching the product in Europe. The company announced the launch and clearance at the EuroPCR meeting in Paris this week. […]
Correction: Federal appeals court denies Endotach in Medtronic stent graft patent case
CORRECTION May 9, 2016: This article originally stated that the appeals court ruled against Medtronic. A federal appeals court today upheld a U.S. Patent & Trademark Office decision invalidating a stent patent licensed to Endotach, a subsidiary of patent troll Acacia Research, in its patent battle with Medtronic (NYSE:MDT). Endotach sued Medtronic in 2012, alleging that the medtech giant infringed a […]
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 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 […]