Gore commences new study of Viabahn Endoprosthesis

Gore has commenced a new clinical study assessing its Viabahn Endoprosthesis for the treatment of in-stent restenosis in the superficial femoral artery.

The post-approval Gore RELINE MAX Clinical Study will enroll 108 patients, largely in the US, with up to a 27 cm lesion length who have already failed stenting. This group is considered one of the most difficult lower limb disease patient populations to treat.

Gore's VIABAHN Endoprosthesis features a Heparin Bioactive Surface and is able to traverse tortuous areas of the artery, conforming closely to its complex anatomy. It is designed to be the lowest profile, most flexible self-expanding stent-graft available.

It is constructed with a durable, reinforced, biocompatible, expanded ePTFE liner and attached to an external nitinol stent structure, with its Heparin Surface intended to provide sustained thromboresistance.

Ben Beckstead, clinical and technical peripheral interventional business unit leader at Gore, said: "The original Gore RELINE Clinical Study saw great results, and we expect to confirm the benefits of the device for this indication with the Gore RELINE MAX Clinical Study."

Data from the earlier Gore RELINE Clinical Study was used to support the company's application for US regulatory approval.