US trial go-ahead for Thoratec's CABG (coronary artery bypass graft) graft:
This article was originally published in Clinica
Executive Summary
Thoratec Laboratories has received permission from the US FDA to begin a clinical trial of its Aria coronary artery bypass graft (CABG) under an investigational device exemption. The AEGIS/US (AlternativE Graft Investigational Study) trial will assess the prosthetic graft, which incorporates the company's proprietary biomaterial Thoralon, in bypass patients who have too few or no suitable vessels of their own. Pleasanton, California-based Thoratec said it was the first company to gain FDA approval to begin US clinical trials for a prosthetic aorta-to-coronary artery bypass graft for such patients. Trials of the graft have been underway in Canada since late last year.