W.L. Gore & Associates said today it won FDA premarket approval for its Tigris self-expanding vascular stent designed for treating 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 interventional biz unit Ray Swinney said in a press release.
The company touted data from a study used to support approval of the device which reported a 0% rate of fractures versus the 27% from the control arm.
“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. The precision offered by this flexible, dual component device allows for easy insertion and predictable clinical outcomes, even in challenging anatomy,” Dr. John Laird said in prepared remarks.
In June, Gore said it won CE Mark approval in the European Union for its Excluder conformable device designed to treat abdominal aortic aneurysms in patients with challenging anatomies.
The newly cleared Excluder device won approval for patients with either proximal aortic neck angles of up to 90 degrees or a minimum aortic neck length of 10 mm, the company said.