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FDA approves vascular stent for PAD

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W.L. Gore and Associates announced that the FDA has approved the Tigris Vascular Stent for the treatment of patients with peripheral artery disease, according to a company press release.

The self-expanding stent features a dual-component structure comprised of single-wire nitinol stent with flexible and biocompatible fluoropolymer interconnections, specifically designed to withstand biomechanical forces without fractures, even in complex anatomies, according to the release. The wire nitinol wire frame is interconnected by a durable expanded polytetrafluoroethylene structure to allow flexibility without sacrificing strength, according to the release.

John R. Laird

 “The Tigris Vascular Stent has an innovative design that is very different from any of the other nitinol stents that we currently use. The extreme flexibility of this stent makes it well suited for the superficial femoral artery and proximal popliteal artery, and the delivery system is highly accurate,” John R. Laird, MD, professor of medicine and medical director of the UC David Vascular Center, stated in the release.

In an FDA-supported U.S. clinical study that supported approval, there were no fractures among participants who received the stent compared with a 27% fracture rate in the control arm, according to the release.

The device gained CE mark in 2011, according to the release.

Disclosure: Laird reports consulting and serving on advisory boards for Abbott Vascular, Bard, Boston Scientific and Medtronic, and receiving research support from W.L. Gore and Medtronic.