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

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.

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.

Asking for those interim results was "a very unusual request from the FDA," Rogers told the news source, "but it is what it is."

"There was a question of whether the adverse-event rate for neurological events was higher with HeartWare, so that’s what prompted the company to go back into the data set and identify factors that may be associated with that, and one of the factors that came out was high blood pressure," he added.

In June 2013 the FDA granted HeartWare conditional approval for another 360-patient cohort, expanding the original ENDURANCE trial to evaluate the effect of closer blood pressure monitoring on neurological events. At the time, HeartWare said that the new study aimed to "confirm observations from Endurance that sites adhering to more regular monitoring and management of patient blood pressure witnessed a notably lower incidence of neurological events."

Rogers hopes to use data from both the original and the expanded cohort of patients to draw conclusions about patient outcomes with the heart pump as a destination therapy, but combining the data could mean diluting important warnings.

"This field is still in its relative youth, and there are things we don’t know about the pumps," he told The Heart. "We were assuming that those 2 pumps we were testing in ENDURANCE are the same, and they are not, they are very different pumps. So it may be that BP management is more important with one than the other."

HTWR shares were flat at $80.21 as of about 12:50 p.m. today, still trending downward overall since the company released a mixed Q2 earnings report earlier this month. The company came under pressure after it missed Wall Street’s loss-per-share forecast on lower-than-expected U.S. sales of its implantable heart pump during the 2nd quarter.

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