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Thoratec Announces HeartMate 3 CE Mark Trial Met Primary Endpoint


Thoratec Corporation (NASDAQ: THOR) today announced results from the HeartMate 3™ CE Mark trial.  HeartMate 3 met the primary endpoint, a comparison of six month survival to a performance goal derived from the INTERMACS registry, with six month survival of 92% surpassing the performance goal and representing the highest six month survival reported in a LVAD CE Mark clinical trial.  Results of the HeartMate 3 CE Mark trial were presented today during the 19th Annual Scientific Meeting of the Heart Failure Society of America (HFSA 2015) in Washington, DC. 

"The CE Mark trial data represents a very positive initial experience with HeartMate 3, including high survival rates, material improvement in functional status, and very low adverse event rates highlighted by zero pump thrombosis events," said Dr. Ivan Netuka, presenter of the HeartMate 3 CE Mark study data at HFSA and Deputy Head at the Institute for Clinical and Experimental Medicine (IKEM) in Prague, Czech

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