FLAGSTAFF, Ariz.--(BUSINESS WIRE)--The GORE® TIGRIS® Vascular Stent, a flexible self-expanding stent to treat peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) developed by W. L. Gore & Associates, Inc. (Gore), demonstrated that it is a safe and effective device that can be incorporated into a modern “leave-nothing-behind” treatment algorithm that reserves stent usage for more challenging patients. These findings were recently presented at LINC 2019 in Leipzig, Germany.
To further demonstrate the complete confidence that Gore has in this device’s efficacy in the challenging region behind the knee, the company also announced today the launch of its Fracture-Free Assurance Program for the device in the United States. Under the program, Gore will provide a refund for device fractures within 10 years of implantation. The Fracture-Free Assurance Program is subject to the terms and conditions at goremedical.com/fracture-free.
“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 pre-dilation 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,” commented Martin Werner, MD. “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 ePTFE 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.”
The prospective, physician-sponsored registry study evaluated the safety and efficacy of the GORE TIGRIS Vascular Stent in treating SFA and PPA occlusive lesions of 100 patients at a single site in Austria. At 12 months, the device met its primary endpoint demonstrating 93 percent primary patency and 100 percent secondary patency. Patients with the device had 95 percent freedom from target lesion revascularization (TLR) and an improved ankle brachial index (ABI) was observed with an average ABI improvement of 0.21 (from 0.69 at baseline to 0.90 at the 12-months follow-up). Additionally, zero stent frame fractures were observed at 12 months. This and other studies showing a lack of stent frame fractures led Gore to create the new Fracture-Free Assurance Program confirming its confidence in the stent. All devices were successfully implanted with no device related complications at the time of implant or within the 30-day implant window.
“Peripheral arterial disease in distal anatomy was previously very difficult to treat effectively via stents because the region behind the knee led to high fracture rates. At Gore, we tackled this challenge head on by designing a stent that flexes with the knee while remaining strong to prevent stent frame fractures,” commented Eric Zacharias, Vascular Leader at Gore. “The extensive data that we have from our previous investigational device exemption (IDE) study and this most recent prospective study show the GORE TIGRIS Vascular Stent is able to deliver precise placement and conformability in complex anatomies leading to long-term efficacy and safety. We have so much confidence in the data behind this device that we have launched our Fracture-Free Assurance Program.”
The GORE TIGRIS Vascular Stent is part of Gore’s portfolio of devices for the treatment of PAD including the GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, and GORE® PROPATEN® Vascular Graft.
For more information on the GORE TIGRIS Vascular Stent visit goremedical.com/tigris
For full details on the Fracture-Free Assurance Program visit goremedical.com/fracture-free
Medical Products Division
Gore engineers devices that treat a range of cardiovascular and other health conditions. With more than 40 million medical devices implanted over the course of more than 40 years, Gore builds on its legacy of improving patient outcomes through research, education and quality initiatives. Product performance, ease of use and quality of service provide sustainable cost savings for physicians, hospitals and insurers. Gore is joined in service with clinicians and through this collaboration we are improving lives. https://www.goremedical.com/
*For complete indications and other important safety information for Gore commercial products referenced herein, refer to applicable Instructions for Use (IFU).
W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Founded in 1958, Gore has built a reputation for solving complex technical challenges in the most demanding environments — from revolutionizing the outerwear industry with GORE-TEX® fabric to creating medical devices that improve and save lives to enabling new levels of performance in the aerospace, pharmaceutical and mobile electronics markets, among other industries. The company is also known for its strong, team-oriented culture and global recognition from the Great Place to Work® Institute. Headquartered in Newark, Del., Gore employs 9,500 Associates and generates annual revenues of $3.5 billion. www.gore.com
Products listed may not be available in all markets.
GORE®, PROPATEN®, TIGRIS®, VBX, and VIABAHN® are trademarks of W. L. Gore & Associates.
AX1412-EN1 JANUARY 2019