Gore touts 12-month Tigris stent study data

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, m...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Stents Vascular W.L. Gore & Associates Source Type: news