The Advance clinical trial evaluates the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure and the primary endpoint of the trial is survival on the originally implanted device or transplanted or explanted for recovery at 180-days.

As part of the Advance study, 140 patients at 30 US clinical sites have received HeartWare HVAD pumps and the final implant in Advance was performed in February 2010, and the last follow-up evaluation at 180-days was in August 2010.

HeartWare currently anticipates submitting pre-market application (PMA) to the FDA, for the approval of the HeartWare System for the bridge-to-transplant indication in December of the current year.