HeartWare International has submitted a pre-market approval application to the FDA for its HeartWare ventricular assist system as a bridge to heart transplantation for patients with end-stage heart failure.
The submission includes data from HeartWare's pivotal ADVANCE clinical trial, an FDA approved investigational device exemption (IDE) study designed to evaluate the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.
Under ADVANCE, 140 patients at 30 hospitals in the U.S. received the HeartWare investigational device between August 2008 and February 2010. The final implant in ADVANCE was performed in February 2010, and the last follow-up evaluation at 180 days was in August 2010, according to the Sydney, Australia-based company.
The FDA has since approved an IDE supplement that allows HeartWare to enroll a second allotment of 54 patients in its ADVANCE bridge-to-transplant clinical trial under a continued access protocol.