W L Gore & Associates (Gore) has obtained the US Food and Drug Administration (FDA) approval of its GORE TIGRIS Vascular Stent to treat peripheral artery disease (PAD).
The GORE TIGRIS Vascular Stent is a third generation, self-expanding and dual-component stent featuring a fluoropolymer / nitinol design which has been designed to improve the anatomy conforming to the natural movement of the knee.
Its dual component structure is made from a single-wire nitinol stent with flexible and biocompatible fluoropolymer interconnections.
The stent can withstand biomechanical forces, such as extension, compression, flexion and torsion, without causing fractures in complex anatomies, namely the superficial femoral artery (SFA) and proximal popliteal artery (PPA).
The US clinical study supporting the FDA approval demonstrated the usage of TIGRIS stent resulting in zero fractures.
Davis, California-based interventional cardiologist John Laird said: “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.”
The device also features Gore's CBAS Heparin Surface which is a durable heparin bonding technology designed to inhibit thrombus formation, a common issue in both bare metal and drug-eluting stents.
The end-point covalent bonding attaches the heparin to the stent surface allowing the bioactive site to interact with the blood to help prevent clotting.
Image: GORE TIGRIS Vascular Stent. Photo: courtesy of Business Wire.