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# FDA Approves Gore’s Tigris Vascular Stent
- URL: https://www.fdaweb.com/fda-approves-gores-tigris-vascular-stent/
- Published: 2016-08-02T12:00:00.000Z
- Updated: 2026-09-14T21:20:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136369

FDA has approved a W.L. Gore & Associates PMA for the Gore Tigris Vascular Stent, a dual-component stent with a fluoropolymer/nitinol design. The device was designed to improve anatomical conformability with the natural movement of the knee when treating peripheral artery disease, the company says. “The stent has been designed to weather biomechanical forces (extension, compression, flexion and torsion) without fractures, even in the most complex anatomies, namely in the superficial femoral artery (SFA) and proximal popliteal artery (PPA),” the company says. Approval was based in data from a U.S. clinical study that showed the Tigris stent had no fractures, while the control devices experienced a 27% fracture rate.