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HeartWare (HTWR)'s Still Chasing PMA, More Study Results on the Way


8/21/2013 8:37:33 AM

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Massachusetts medical device maker HeartWare is still working on its premarket approval application with the FDA, hoping new study results will help quell concerns about a higher rate of neurological events with its implantable heart pump. Framingham, Mass.-based medical device company HeartWare International (NSDQ:HTWR) hopes its newly approved cohort of heart pump clinical trial patients will help quell concerns about "neurological events" associated with its implant in earlier studies.North Carolina cardiologist Dr. Joseph Rogers, a principal investigator for HeartWare's ENDURANCE trial, told reporters that he plans to submit the latest clinical findings for presentation at the 2014 American Heart Assn. meeting or the subsequent meeting of the American College of Cardiology, including both the original patient cohort as well as the supplemental cohort that is receiving blood pressure management in addition to the implantable heart pump.

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