The FDA approved W.L. Gore’s third-generation, self-expanding stent for the treatment of peripheral artery disease. CE-marked in 2011, the device is designed to work better with natural knee movement when implanted in arteries in the leg.
Peripheral artery disease (PAD) refers to the narrowing of peripheral arteries, most commonly in the legs. Stents are usually implanted in the femoral artery in the thigh or the popliteal artery in the back of the knee.
The dual-component stent comprises a single-wire nitinol stent with flexible connections made of biocompatible fluoropolymer, the company said in a statement. This design allows the stent to withstand movement, such as extension, compression, flexion and torsion, without breaking. The FDA approval is supported by a clinical trial finding that the Tigris stent did not fracture in patients who had them, while stents in the control arm posted a 27% fracture rate, according to the statement.
“The TIGRIS Vascular Stent has an innovative design that is very different from any of the other nitinol stents that we currently use,” said Dr. John Laird, an interventional cardiologist, in the statement. “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 third-gen product improves upon first-gen devices, which had metal connections instead of polymer ones. This led to the stiffening of arteries, a high fracture rate and poor outcomes, Gore said. While second-gen stents incorporated new helical connections, they still had limited success when implanted in the femoral and popliteal arteries.
Other uncovered (or bare), self-expanding stents are made only of nitinol, while Tigris is made of two different components, nitinol and the fluoropolymer ePTFE, a Gore spokeswoman told FierceMedicalDevices via email. Gore also markets Viabahn, which is made of nitinol and encased completely in ePTFE, and so, is considered a covered stent.
Gore expects to debut the stent in the U.S., thus broadening the global user base of the device. The company believes this will also have a positive impact on ex-U.S. sales, the spokeswoman said. And while Viabahn is also indicated for PAD, the covered stent will not compete with the self-expanding, uncovered Tigris for market share, so the company does not expect “cannibalization.”
Medtronic ($MDT) and C.R. Bard ($BCR) market drug-coated angioplasty balloons to treat PAD, while Boston Scientific ($BSX) won an FDA nod for its self-expanding stent last summer.
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