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$HTWR: HeartWare confirms it received FDA approval for HeartWare Ventricular Assist System as a bridge to heart transplantation for patients with advanced heart failure (81.90 -0.11)
HeartWare's pre-market approval (PMA) submission included data from the Company's pivotal ADVANCE clinical trial, an FDA approved Investigational Device Exemption (IDE) study designed to evaluate the HeartWare System as a bridge to heart transplantation for patients with end-stage heart failure. The ADVANCE study achieved a 94% survival at 6 months and successfully met its primary endpoint of establishing non-inferiority between the investigational device and comparator arm of the study, which was derived from contemporaneous patients from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) [p<0.0001]. Co will host a conference call today at 3:00 p.m. U.S. Eastern Time to discuss approval of the HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure.... shares halted.