W.L. Gore & Associates today released 12-month results from a registry study of its Gore Tigris vascular stent designed to treat peripheral artery disease in the superficial femoral artery and proximal popliteal artery, touting that the device was shown to be safe and effective.
Results from the trial were presented at the LINC 2019 meeting in Leipzig, Germany, the Newark, Del.-based company said.
The 3rd-generation dual-component stent features a combination of flexible fluoropolymer and single-wire nitinol and is designed to conform to the natural movement of the knee, Gore said.
Investigators in the physician-sponsored registry study sought to evaluate the safety and efficacy of the Gore Tigris stent in treating occlusive lesions of the superficial femoral artery and proximal popliteal artery in 100 patients at a single Austrian site, the company said.
Data at 12 months indicated that the study met its primary endpoint, demonstrating a 93% primary patency rate and 100% secondary patency rate. Study investigators reported a 95% freedom from target lesion revascularization and average improvements on the ankle brachial index of 0.21.
Results indicated a 100% successful implantation rate with no reported device related complications at the time of implant or within a 30-day implant window.
“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. 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,” Dr. Martin Werner said in a prepared statement.
Gore said that data showing no frame fractures in this study and in others led it to create its new Fracture-Free Assurance Program, through which the company will provide refunds for device fractures within 10 years of implantation.
“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. The extensive data that we have from our previous investigational device exemption 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,” Gore vascular leader Eric Zacharias said in a press release.
Last September, Gore said that it acquired stealthy Pipeline Medical Technologies and its mitral repair program for an undisclosed amount.
