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News Breaks November 20, 2012 14:45 EDT HTWR HeartWare 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." News For HTWR From The Last 14 Days Check below for free stories on HTWR the last two weeks. Sign up for a free trial to see the rest of the stories you've been missing. June 17, 2013 08:51 EDT HTWR HeartWare gets conditional approval from FDA to enroll patient cohort in trial HeartWare announced that the FDA has granted conditional approval to an IDE Supplement that allows HeartWare to commence enrollment in an additional patient cohort for ENDURANCE, the company's pivotal, Destination Therapy clinical study. The primary endpoint of the trial is stroke-free (Modified Rankin Score > 4) survival at two years, defined as alive on the originally implanted device, transplanted or explanted due to patient recovery. Secondary endpoints include adverse events such as bleeding and infection, as well as functional status, hospitalization, assessment of neuro-cognitive function and patient quality of life. The final implant was conducted in May, which will result in the final patient reaching the two-year follow up point in May 2014. Sign up for a free trial to see the rest of the stories you've been missing.