W.L. Gore & Assoc. said the FDA granted pre-market approval for a new indication for its Viabahn endoprosthesis, to treat failed bare-metal stents in the peripheral vasculature.
The Viabahn device 1st won an FDA nod in 2005 for treating femoral artery lesions. A string of expanded indications has followed, including the most recent approval for treating in-stent restenosis in the superficial femoral artery, Gore said.
It’s designed to re-line the failed stent and adjacent vessel, according to a press release. In clinical studies, patients using the Gore Viabahn device were 3 times less likely than angioplasty patients to need a revascularization procedure, Gore said, noting that the Viabahn device kept arteries open in 75% of cases after 12 months, more than 45% higher than the angioplasty arm.
“The treatment of failed bare metal stents has long been a perplexing problem for vascular specialists, in which only a few treatments are FDA-approved and limited compelling clinical data exist,” Dr. Peter Soukas of the Brown Medical School said in prepared remarks. “This new indication for the Gore device and the accompanying data from the Reline trial provide physicians with the means to intervene confidently on a failed bare metal stent, extending the life of the intervention and improving patient outcomes.”
“The Gore Viabahn endoprosthesis remains 1 of the most studied stents or stent-grafts for use in the SFA,” Gore peripherals business leader Ray Swinney said in prepared remarks. “With the successful completion of the Gore Reline clinical study, physicians can now use this trusted device to solve the toughest challenges in the SFA and expand the long-term treatment options available for patients experiencing in-stent restenosis. FDA approval for this critical indication supports our dedication to pursuing innovative clinical solutions and our strong commitment to the physicians and patients we serve.”