The FDA's Circulatory System Devices Panel will review HeartWare International's premarket approval (PMA) application for the HeartWare Ventricular Assist System on April 25.
HeartWare's PMA submission encompasses data from HeartWare's pivotal ADVANCE bridge-to-transplant clinical trial, an FDA-approved Investigational Device Exemption study designed to evaluate the HVAD System as a bridge-to-heart transplantation for patients with end-stage heart failure. In the ADVANCE trial, 140 patients at 30 hospitals in the U.S. received the HeartWare investigational device between August 2008 and February 2010.
"Notification of the FDA advisory committee meeting represents continued progress toward our goal of obtaining U.S. approval of the HVAD System for patients with end-stage heart failure," stated Doug Godshall, president and CEO of Sydney, Australia-based HeartWare. "We look forward to discussing the efficacy and safety data for the HVAD Pump with the members of the panel and the FDA review team."