November 21, 2012

HeartWare Device Wins FDA Approval

HeartWare International of Framingham has received federal government approval for a product that aids heart transplant patients with advanced heart failure, the company announced.

The product, the HeartWare Ventricular Assist System, features a pump designed to be implanted next to a patient's heart, avoiding the abdominal surgery generally required to implant similar devices. The pump weighs about five ounces and is intended to be used as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure, the company said.

The approval by the U.S. Food and Drug Administration "marks the culmination of an extensive clinical effort and represents an exciting advance in the treatment of late-stage heart failure patients," said company president and CEO Doug Godshall.

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