W L Gore & Associates (Gore) has obtained the expanded approval from the US Food and Drug Administration (FDA) for its Viabahn endoprosthesis to treat stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access (AV access) grafts.
The device is constructed with a durable, reinforced, biocompatible, expanded polytetrafluoroethylene (ePTFE) liner attached to an external nitinol stent structure that acts as a barrier to in-stent restenosis.
The stent-graft features the proprietary heparin-bonded technology to the proven combination of ePTFE and nitinol.
This proprietary surface technology is intended to provide a thromboresistant surface through sustained heparin bioactivity.
According to the company, the Gore Viabahn Device is the lowest profile, most flexible, self-expanding, small-diameter, endoprosthesis available in the market.
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).
Vascular Access Center interventional radiologist Dr Thomas Vesely said that he has confidence in the Gore Viabahn endoprosthesis.
"The IDE approval study showed that the Gore Viabahn Device provides longer primary patency when compared with repeated angioplasty for these lesions," Dr Vesely said. "For these reasons, the Gore Viabahn endoprosthesis is an indispensable device in my endovascular toolbox."
In November, the company received the FDA approval for the 25cm Viabahn endoprosthesis in treatment of peripheral artery disease.
The 25cm endoprosthesis, which is designed to cover long-segment lesions in the superficial femoral artery, is the longest length stent-graft available and helps potentially reduce the need for multiple devices.
Gore peripheral interventional business unit leader Ray Swinney said: "We are committed to exceeding the expectations of vascular surgeons, interventional radiologists and interventional nephrologists who have been seeking a better solution for their dialysis access patients."
According to GlobalData estimates, the US stent grafts market was valued at $747m in 2012 and is expected to grow at a CAGR of 4.2% to reach $993m by 2019.
Image: The FDA approves for Revision of the Arteriovenous Access. Photo: courtesy of Business Wire/ W L Gore & Associates.