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News Breaks | | | | January 7, 2013 | | 13:45 EDT |  | HTWR | HeartWare says Q4 revenue reflects positive launch trends
The company said, "These results reflect positive initial trends in the commercial launch of the HeartWare Ventricular Assist System in the U.S., as approximately 40 percent of fourth quarter revenues were derived from domestic sales. In addition, we remain optimistic about long-term global market growth prospects and HeartWare's role in stimulating that growth. This sentiment is bolstered by our observed revenue growth of approximately 40 percent in the fourth quarter over the fourth quarter of 2011, and approximately 33 percent growth in full-year 2012 revenues over 2011." | |
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News For HTWR From The Last 14 Days Check below for free stories on HTWR the last two weeks. |
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| 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. | |
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