We’ve been watching the news buzz relating to the build up before FDA’s Circulatory Systems Advisory Panel review of the HeartWare® Ventricular Assist system. Well, it’s no great surprise then that the company has now issued a press release confirming that the panel gave it the nod on a 9-2 vote that the benefits outweigh the risks for the use of the system as a bridge to heart transplantation in patients with end-stage heart failure.
The Advisory Committee’s recommendation, while not binding, will be considered by the FDA in its review of the Premarket Approval (PMA) application that HeartWare submitted for the HeartWare® Ventricular Assist System in December 2010.
“We are pleased with the panel’s strong recommendation and would like to thank them for their thoughtful review of the data presented from the ADVANCE study,” said Doug Godshall, CEO and President of HeartWare. “The Advisory Committee meeting outcome represents an important step toward approval of the HeartWare® Ventricular Assist System in the United States, and we look forward to continuing our dialogue with the FDA as it finalizes its review of our PMA. HeartWare remains committed to optimizing outcomes for patients with end-stage heart failure and looks forward to expanding the clinical experience for the device in the future.”
Source: Heartware International Inc., PR Newswire
published: April 26, 2012 in: Approval/Clearance, Cardio, Regulatory, USA