January 13, 2011 – HeartWare International has submitted a Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration for its ventricular assist system. The system acts as a bridge to heart transplantation for patients with end-stage heart failure.
The submission includes data from the company’s pivotal ADVANCE clinical trial, an FD- approved investigational device exemption (IDE) study designed to evaluate the system. In the trial, 140 patients at 30 hospitals in the United States received the device between August 2008 and February 2010. The final implant was performed in February 2010, and the last follow-up evaluation at 180-days was in August 2010.
Previously announced results for ADVANCE showed that 92 percent of the 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 demonstrated that 94 percent of the investigational device patients enrolled in the study achieved a survival endpoint at 180 days.
Results for the comparator arm of the study, derived from 499 contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) demonstrated 90 percent success of the primary endpoint at 180 days. Based on these results for the primary endpoint of the ADVANCE study, noninferiority of the investigational device was established [p
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