FDA clears Thoratec's Vectra Access Graft:
This article was originally published in Clinica
Executive Summary
Thoratec Laboratories has received 510(k) marketing clearance from the US FDA for its Vectra Vascular Access Graft. The device incorporates the Pleasanton, California-based company's biomaterial, Thoralon, and is designed to provide access to the bloodstream in end-stage renal disease patients undergoing haemodialysis. It has been available in Japan, Australia and Canada for several years, and in Europe since last year.