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HeartWare seeks FDA nod for heart device

Tue, 12/28/2010 - 8:36am
Mass High Tech: The Journal of New England Technology

HeartWare International Inc. has submitted its Ventricular Assist System to the U.S. Food and Drug Administration for Pre-Market Approval (PMA) as a bridge to heart transplantation for patients with end-stage heart failure, the company reported today.

The Framingham company submitted data, as part of the PMA, from its clinical trial testing the Ventricular Assist System in 140 patients at 30 U.S. hospitals. It announced last month that it had received favorable results from the trial, showing that “92 percent of the investigational device patients met the per protocol primary endpoint of the trial, which was defined as alive on the originally implanted device, transplanted or explanted for recovery at 180 days.”

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