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November 20, 2012
14:45 EDTHTWRHeartWare confirms FDA approval for HeartWare Ventricular Assist System
HeartWare International confirmed that it has received approval from the United States Food and Drug Administration for the HeartWare Ventricular Assist System as a bridge to heart transplantation in patients with end-stage heart failure. The HeartWare System is currently the leading ventricular assist device implanted in patients outside of the United States, having received CE Marking in the European Union in 2009, and Australian Therapeutic Goods Administration approval in 2011. In other clinical development for the HeartWare Ventricular Assist System, HeartWare has completed enrollment of a 450-patient destination therapy study at 50 U.S. sites. The final patients were implanted in May, with a two-year, primary endpoint follow-up period. HeartWare has requested a Continued Access Protocol allocation for destination therapy from the FDA. The company said, "Our team is positioned to commence the commercial rollout of the HeartWare System immediately, first facilitating broad use by the 50 U.S. hospitals that participated in our clinical studies, and then with training and expansion to additional U.S. hospitals."
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