Heartware International Inc. (HTWR) said it has submitted a Pre-Market Approval or PMA application to the U.S. Food and Drug Administration for the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure.
The PMA submission includes data from HeartWare's pivotal ADVANCE clinical trial, an FDA approved IDE study designed to evaluate the HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with end-stage heart failure, HeartWare added.
Earlier announced results for ADVANCE showed that 92% 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. Further, ADVANCE demonstrated that 94% of the investigational device patients enrolled in the study achieved a survival endpoint at 180 days.
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