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News Breaks | | | | November 20, 2012 | | 14:52 EDT |  | HTWR | HeartWare to resume trading at 3:10 pm ET
Quotation to resume at 3:05 pm ET, according to Nasdaq. | |
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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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