Gore wins Health Canada approval for Tigris vascular stent

W.L. Gore & Associates said today it won Health Canada approval for its Tigris dual-component vascular stent designed to treat peripheral artery disease.

The 3rd-generation dual-component stent features a combination of flexible fluoropolymer and single-wire nitinol and is designed to conform to the natural movement of the knee, the Newark, Del.-based company said.

“At Gore, we pride ourselves in continuous evaluation of how our technologies can benefit patients. To design an uncovered stent that navigates and conforms to the complex anatomy of the artery, we leveraged our long history with endovascular devices to develop the Gore Tigris Vascular Stent. The addition of this device to our peripheral interventional portfolio enables physicians to treat more diverse cases with Gore’s best in class products,” Gore peripheral intervention biz unit leader Ray Swinney said in a prepared statement.

A US clinical study which the company used to support FDA approval of the device reported a 0% rate of fractures versus the 27% from the control arm at 12 months. Gore’s Tigris stent won a nod from the FDA in August last year, and gained CE Mark approval in the European Union in 2011.

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