HeartWare International has received the US Food and Drug Administration (FDA) approval for an investigational device exemption (IDE) supplement to enroll a third allotment of 94 additional patients, in its 'Advance' bridge-to-transplant clinical trial under a Continued Access Protocol (CAP).
The FDA granted two prior allotments of 54 patients each in April and September 2010, and the final patient from the second cohort was implanted earlier this month.
HeartWare’s Advance clinical trial is an FDA approved IDE study designed to evaluate the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.
Under the Advance study, 140 patients at 30 US clinical sites received HeartWare HVAD pumps, making it the largest bridge-to-transplant pivotal trial to date.
HeartWare submitted to the FDA a pre-market approval (PMA) application seeking approval of the HeartWare System 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.