Gore Medical said it received CE Mark approval for its Viabahn vascular device for the treatment of obstructed peripheral veins in hemodialysis patients.
The Flagstaff, Ariz.-based company said the approval covers the treatment of obstructed peripheral veins, excluding the venae cavae and pulmonary veins.
Viabahn is also approved in Europe to treat peripheral vascular disease in superficial femoral arteries, according to Gore’s website.
“We are pleased to expand the Gore Viabahn endoprosthesis to hemodialysis access in Europe,” said Ray Swinney, head of Gore’s 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.”
In September Gore won pre-market approval from the FDA for the Viabahn device in treating peripheral artery disease.
