FDA Approves Gore's Tigris Vascular Stent

August 2, 2016—Gore & Associates announced US Food and Drug Administration (FDA) approval of its Tigris vascular stent, a dual-component stent with a fluoropolymer/nitinol design. The third-generation Tigris self-expanding stent, which achieved European CE Mark approval in 2011, was designed to improve anatomical conformability with the natural movement of the knee when treating peripheral artery disease.

According to the company, the Tigris’ dual-component structure is made from a single-wire nitinol stent with flexible and biocompatible fluoropolymer interconnections. The device also features Gore’s CBAS heparin surface, which is designed to resist thrombus formation. Endpoint covalent bonding keeps heparin anchored to the stent surface while the bioactive site remains free to interact with the blood to help prevent clotting.

The stent has been designed to withstand biomechanical forces (extension, compression, flexion, and torsion) without fractures, including in the complex anatomies of the superficial femoral artery and proximal popliteal artery. In the United States clinical study that supported FDA approval of the device, the Tigris stent was found to have zero fractures versus the control-arm devices that experienced a 27% fracture rate, noted the company.

John R. Laird, MD, commented in Gore’s announcement, “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. Laird is an interventional cardiologist in Davis, California.