Data Presented From Austrian Registry of Gore's Tigris Vascular Stent
January 24, 2019—Gore & Associates announced that findings demonstrating the safety and effectiveness of the company's flexible, self-expanding Tigris vascular stent to treat peripheral artery disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The study showed that the device can be incorporated into a modern “leave-nothing-behind” treatment algorithm that reserves stent usage for more challenging patients. The data were presented at LINC 2019, the Leipzig Interventional Course held January 22–25 in Leipzig, Germany.
The prospective, physician-sponsored registry study evaluated the safety and efficacy of the Tigris vascular stent for treating SFA and PPA occlusive lesions in 100 patients at a single site in Austria.
At 12 months, the device met its primary endpoint, with 93% primary patency and 100% secondary patency. Patients who were implanted with the device had 95% freedom from target lesion revascularization and an average improved ankle brachial index of 0.21 (from 0.69 at baseline to 0.90 at the 12-month follow-up). Additionally, zero stent frame fractures were observed at 12 months.
In the announcement, Martin Werner, MD, commented, "This very positive data on the Gore Tigris vascular stent is extremely relevant because the stent was only used in patients that did not respond to predilation with a balloon, meaning the stent was only implanted in challenging patients that required mechanical stabilization, the less challenging patients were treated with drug-coated balloons.”
Dr. Werner noted, “Several features about this stent make it ideal for use in the high-motion region behind the knee—it is on target, every time with no geographic misses during deployment, its unique combination of nitinol and expanded polytetrafluoroethylene make it highly flexible and conformable and it is one of the safest and easiest to use stents on the market. I’m impressed with the very positive patency rates we’ve seen at 12 months and look forward to seeing if these encouraging results are maintained at 24 months.”
Additionally, Gore noted that this and other studies showed a lack of stent frame fractures and all devices successfully implanted with no device-related complications at the time of implantation or within the 30-day implantation window.
With the confidence from these findings, the company announced the launch of its Fracture-Free Assurance Program for the device in the United States. Subject to the terms and conditions of the program, Gore will provide a refund for device fractures within 10 years of implantation.