HeartWare's still chasing PMA, more study results on the way

August 20, 2013 by Arezu Sarvestani

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.

Heartware's still chasing PMA for destination therapy, more study results on the way

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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The ENDURANCE trial hit a speed-bump early on when researchers noted an unexpectedly high rate of ischemic and hemorrhagic strokes in HeartWare patients (6.7% and 5.1% respectively), as compared to a control pump (4.3% and 0%, respectively). Those findings prompted the FDA to take a peek at HeartWare's interim results, and the company eventually targeted blood pressure management as a potential avenue for stemming further adverse events, TheHeart.org reported.