W.L. Gore & Assoc. said it won pre-market approval from the FDA for its 25cm Viabahn endoprosthesis for peripheral arterial disease, claiming the device as the longest stent graft available in the U.S.
Newark, Del.-based Gore said the FDA approved the Viabahn device, which is treated with a heparin bio-active coating, for treating symptomatic PAD in the superficial femoral artery.
"The Gore Viabahn endoprosthesis is the only device of its kind approved for both the SFA and iliac artery. The availability of the longer-length 25cm device aligns well with the findings of multiple studies utilizing the endoprosthesis," peripheral interventional business leader Ben Beckstead said in prepared remarks.
It’s a much-needed 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 recently started to pay out damages after a federal judge upheld Bard’s win, beginning with a $35.7 million royalty payment last month.
