January 27, 2011 – The U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) Supplement allowing more patients to participate in the ADVANCE trial. The bridge-to-transplant will let a third allotment of 94 more patients under a Continued Access Protocol (CAP).
HeartWare's ADVANCE clinical trial is an FDA approved IDE study designed to evaluate its ventricular assist system as a bridge to heart transplantation for patients with end-stage heart failure. Under the ADVANCE study, 140 patients at 30 U.S. clinical sites received HeartWare HVAD pumps, making it the largest bridge-to-transplant pivotal trial to date. The company submitted a Pre-Market Approval (PMA) application to the FDA for the bridge-to-transplant indication in December 2010.
Patient enrollment under the third CAP can now commence at the 30 centers participating in the ADVANCE clinical trial, subject to Institutional Review Board approvals at these sites.
For additional information: www.heartware.com