Gore's Tigris Vascular Stent Approved in Canada to Treat PAD
March 9, 2017—Gore & Associates announced that Health Canada has approved the company's Tigris vascular stent. The third-generation, self-expanding device gained European CE Mark approval in 2011 and received US Food and Drug Administration (FDA) approval in 2016.
According to Gore, the Tigris stent is designed to improve anatomical conformability with the natural movement of the knee when treating peripheral artery disease. The device features a dual component structure made from a single-wire nitinol stent with flexible and biocompatible fluoropolymer interconnections.
The stent has been designed to withstand biomechanical forces without fracturing withiin the most complex anatomies, specifically the superficial femoral and popliteal arteries. In the United States clinical study that supported FDA approval, the Tigris vascular stent demonstrated zero fractures at 12 months, whereas the control arm devices had a 27% fracture rate at 12 months.
The Tigris device also incorporates the company's CBAS heparin surface, which is designed to resist thrombus formation. Endpoint covalent bonding keeps heparin anchored to the stent surface, and the bioactive site remains free to interact with the blood to help prevent clotting, stated the company.