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HeartWare submits PMA application for Ventricular Assist System to FDA

HeartWare International has submitted a Pre-Market Approval (PMA) application to the US Food and Drug Administration (FDA) 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.

The Advance trial results 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.

Additionally, Advance trial demonstrated that 94% of the investigational device patients enrolled in the study achieved a survival endpoint at 180 days.

Based on the results for the primary endpoint of the Advance study, noninferiority of the investigational device was established.