W.L. Gore & Associates today touted expanded FDA approval for its Viabahn endoprosthesis, now indicated for treatment of stenosis and thrombotic occlusions related to synthetic vascular access grafts.
That’s the FDA 2nd win for the Viabahn line in as many months, with FDA approval granted in November for the 25cm Viabahn endoprosthesis in treatment of peripheral artery disease.
"We are pleased to expand the Gore Viabahn endoprosthesis to hemodialysis access," Gore peripheral interventional business unit leader Ray Swinney said in prepared remarks. "We are committed to exceeding the expectations of vascular surgeons, interventional radiologists and interventional nephrologists who have been seeking a better solution for their dialysis access patients."
Gore described the Viabahn device as the "lowest profile, most flexible, self-expanding, small-diameter, endoprosthesis available."
It’s a vital stent graft win for Gore, which appears to be on the losing end of a long-running patent battle with arch-rival C.R. Bard (NYSE:BCR). Gore began recently to pay out damages after a federal judge upheld Bard’s win, beginning with a $35.7 million royalty payment last month.