Gore gets US green light for trial of stent graft for AV (arterio-venous grafts):
This article was originally published in Clinica
Executive Summary
WL Gore & Associates has received conditional approval from the US FDA to proceed with a clinical trial to compare use of its stent graft for arterio-venous grafts (AV) graft revisions against the use of percutaneous transluminal angioplasty (PTA) alone. The randomised, multicentre study, called AVIATOR, will test the efficacy and safety of the firm's Viabahn endoprosthesis with Propaten bioactive surface in AV graft revisions at the venous anastomosis in haemodialysis patients. The Flagstaff, Arizona firm's device represents the latest advance in its Viabahn product line.