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FDA approves new hemodialysis indication for Gore's Viabahn Endoprosthesis
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The U.S Food and Drug Administration has granted indication for the Viabahn Endoprosthesis, made by W. L. Gore & Associates, to treat stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous access grafts. This new indication allows for the use of the product in hemodialysis patients.
(Early data show potential for investigational bioengineered blood vessel as dialysis grafts)
“We are pleased to expand the Gore Viabahn Endoprosthesis to hemodialysis access,” said Ray Swinney, business unit leader for the Gore Peripheral Interventional business unit. “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.”
(Lowering catheter rates among hemodialysis patients)
According to Gore, the Viabahn Endoprosthesis allows clinicians to reline patients' arteries to improve blood flow. The endoprosthesis is a self-expanding, nitinol stent lined with an ultra-thin ePTFE graft.