News | February 22, 2012

FDA to Review HeartWare Ventricular Assist Device in April

February 22, 2012 — HeartWare International Inc. announced that a U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel will review the premarket approval (PMA) application for the HeartWare Ventricular Assist Device system on April 25, 2012.

"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," said Doug Godshall, president and CEO of 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, and believe that these data underscore the potential utility of the HVAD system in improving treatment outcomes for end-stage heart failure patients."

HeartWare's PMA submission encompasses data from HeartWare's pivotal Advance clinical trial, an FDA-approved investigational device exemption (IDE) study designed to evaluate the HVAD system as a bridge to heart transplantation for patients with end-stage heart failure. Under Advance, 140 patients at 30 hospitals in the United States received the HeartWare investigational device between August 2008 and February 2010.

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