W. L. Gore & Associates (Gore) has received approval from the US Food and Drug Administration (FDA) for its GORE VIABAHN Endoprosthesis.
The approval has been granted for interventional treatment of in-stent restenosis in the superficial femoral artery (SFA).
The GORE VIABAHN Endoprosthesis is the only stent-graft that received approval for the SFA (de novo, restenotic, and in-stent restenotic disease), iliac artery, and arteriovenous access revision, noted Gore.
The device has been constructed by using ePTFE liner, and features CBAS Heparin Surface, which offers thromboresistance.
Gore peripheral interventional business unit leader Ray Swinney said the GORE VIABAHN Endoprosthesis remains one of the most studied stents or stent-grafts for use in the SFA.
"With the successful completion of the Gore RELINE Clinical Study, physicians can now use this trusted device to solve the toughest challenges in the SFA and expand the long-term treatment options available for patients experiencing in-stent restenosis," Swinney added.
"FDA approval for this critical indication supports our dedication to pursuing innovative clinical solutions and our strong commitment to the physicians and patients we serve," Swinney added.
Gore produces products, including vascular grafts, endovascular and interventional devices, surgical meshes for hernia and soft tissue reconstruction, staple line reinforcement materials and sutures for use in vascular, cardiac, and general surgery.
Image: GORE VIABAHN Endoprosthesis. Photo: courtesy of Business Wire.