PQ Bypass said today it won CE Mark approval for 3 devices designed to treat patients with superficial femoral artery lesions due to peripheral artery disease. The Sunnyvale, Calif.-based company said it won clearance for its Torus stent graft system, PQ Snare and PQ crossing device, all used in the company’s Detour procedure. “With an increased focus […]
Stent Grafts
Gore wins FDA nod, launches Viatorr Tips endoprosthesis in US
W.L. Gore & Associates said today it won FDA premarket approval for and launched its Viatorr Tips endoprosthesis with controlled expansion designed for transjugular intrahepatic portosystemic shunt procedures. The Newark, Del.-based company said that the newly cleared Viatorr Tips endoprosthesis is designed with proprietary ePTFE graft lining to minimize transmural permeation of bile and mucin. […]
Bard logs win in long-running stent graft patent spat with Gore
A Delaware federal jury awarded a win to C.R. Bard (NYSE:BCR) in an ongoing spat with W.L. Gore & Associates over ultra thin stent graft patents. The 8-man jury ruled that Bard’s patent does not infringe on Gore’s patent, and that Gore’s patent is invalid, according to court documents released yesterday.. The ruling is the most recent […]
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 […]
China’s Microport puts $15m into Lombard Medical
Lombard Medical Technologies (NSDQ:EVAR) said today that China’s MicroPort Orthopedics invested $15 million as part of a partnership deal between the 2 companies. Through the partnership, Lombard will seek to accelerate commercialization of its Aorfix and Altura stent grafts for treating abdominal aortic aneurysms. Microport will gain exclusive marketing rights for both products in China and Brazil, as […]
Medtronic wins expanded CE Mark indication for Endurant II stent graft
Medtronic (NYSE:MDT) said today that it won an expanded CE Mark indication in the European Union for its Endurant II/IIs stent graft for treating abdominal aortic aneurysms. The expanded indication covers a new endovascular implantation approach using a parallel graft chimney approach called ChEVAR, which allows the device to be used to treat aneurysms with […]
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 […]
Endologix shares dive on FDA request for more Nellix data
Endologix (NSDQ:ELGX) shares are off nearly -25% today after the company said the FDA asked for more data on its Nellix stent graft for treating abdominal aortic aneurysms. Irvine, Calif.-based Endologix said the federal safety watchdog wants 2-year follow-up data from its EVAS-Forward investigational device exemption study. The additional data submission, expected during the 2nd quarter of […]
Abbott wins Japanese approval for Absorb
Abbott (NYSE:ABT) said today it won approval from the Japanese Ministry of Health, Labor and Welfare for its Absorb bioresorbable heart stent, touting it as the 1st fully dissolving heart stent approved in the country. The stent is now cleared for use in patients with coronary artery disease, the Chicago-based company said, with approval coming […]
Study: Endovascular aneurysm repair shows higher long-term mortality
Endovascular repair of abdominal aortic aneurysms showed a higher mortality rate over the long term compared with open surgical repair, according to a study published yesterday in The Lancet. The study, “Endovascular versus open repair of abdominal aortic aneurysm in 15-years’ follow-up of the UK endovascular aneurysm repair trial 1,” was based on data from the […]