Arizona medical device maker W.L. Gore & Assoc. teased positive results from its REVISE clinical trial, promising to release additional findings during the American Society of Diagnostic & Interventional Nephrology meeting in Phoenix this week.
Gore was light on the details, but said that study results showed that the company’s newly approved Viabahn drug-coated stent graft beat the current standard of care, percutaneous transluminal angioplasty, in treating stenoses or thrombotic occlusions.
The REVISE clinical trial is the only randomized, controlled study of its kind, Gore said. Researchers examined 2 patient groups undergoing revision of arteriovenous prosthetic grafts to re-establish access for dialysis, 1 group with the Viabahn stent-graft and the other with PTA.
Viabahn patients experienced superior target lesion primary patency over 24 months and fewer repeat interventions to maintain secondary patency, according to a Gore press release.
"With the Gore REVISE Clinical Study, we wanted to set out and prove not only that the GORE Viabahn Endoprosthesis can successfully treat stenoses or thrombotic occlusions, but that the device is superior to the current standard of care," Gore peripheral interventional business unit leader Ray Swinney said in prepared remarks. "Investing in clinical studies such as REVISE allows Gore to provide physicians with superior technology that is supported by trusted clinical data."
Gore won FDA approval in November for the 25 cm Viabahn endoprosthesis with indication to treat peripheral arterial disease. The device features a heparin bioactive coating designed to provide sustained anti-thrombotic therapy.