Gore Medical (Flagstaff, AZ) won approval from the FDA for its GORE VIABAHN endoprosthesis to be used in the treatment of “stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access (AV access) grafts,” according to the company. The device has previously been approved for use in revision of artery lesions and revision of arteriovenous access, among other applications.
It’s made out of a nitinol core with a polytetrafluoroethylene (ePTFE) coating on the inside. The company claims this is the slimmest, most flexible self-expanding endoprosthesis on the market.
From Gore’s announcement:
“I have confidence in the GORE VIABAHN Endoprosthesis,” said Thomas Vesely, MD, Interventional Radiologist at the Vascular Access Center in Frontenac Grove, MO. “The device can be precisely deployed and its flexibility allows placement across the elbow and other challenging venous anastomotic locations. I can rapidly and accurately deploy a GORE VIABAHN Device in an emergent situation, and it will provide effective treatment for stenosis at the venous anastomosis of AV access grafts. The IDE approval study showed that the GORE VIABAHN Device provides longer primary patency when compared to repeated angioplasty for these lesions. For these reasons the GORE VIABAHN Endoprosthesis is an indispensable device in my endovascular toolbox.”
In the REVISE Clinical Study (AVR 06-01), the GORE VIABAHN Device group demonstrated statistical superiority of target lesion primary patency as compared to PTA (p = 0.008).
Flashbacks: GORE’s VIABAHN Endoprosthesis Gains FDA Approval for Revision of Arteriovenous Access…; Large Diameter VIABAHN Endovascular Stents Approved in US…; Gore VIABAHN® Endroprosthesis Stent: Now Approved…; Smoother GORE VIABAHN Endoprosthesis Gets Approved in US…
Product page: GORE VIABAHN Endoprosthesis…
Press release: FDA Approves GORE® VIABAHN® Endoprosthesis for Revision of the Arteriovenous Access…
