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FDA approves stent graft for SFA in-stent restenosis
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W.L. Gore has announced that its Viabahn endoprosthesis has received FDA approval for the treatment of in-stent restenosis in the superficial femoral artery.
In addition to this new indication, the self-expanding, low-profile stent graft is also FDA approved in de novo and restenotic lesions in the superficial femoral artery (SFA), and can be used to treat iliac artery and arteriovenous disease. The device features a durable, reinforced, biocompatible and expanded ePTFE liner that is attached to a nitinol stent structure, the manufacturer stated in a press release.
“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,” Peter A. Soukas, MD, assistant professor of medicine at Brown Medical School, Providence, R.I., said in the release. “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.”
In the RELINE trial, patients who received the stent graft were roughly three-times less likely to have target lesion revascularization at 1 year than those who received percutaneous transluminal angioplasty (PTA). Those in the stent graft arm also had a primary patency rate of 74.8%, which was more than 45% higher than the PTA arm, according to the release.