But Thoratec's sharp sell-off Monday may have been an overreaction, analysts said, as HeartWare's device is likely still at least a year away from being approved.
Furthermore, HeartWare is initially aiming for approval of its device for use in patients who are awaiting heart transplants. That means Thoratec will still have years to continue its reign as the only company with a heart pump approved for use in severely ill heart-failure patients who can't receive a transplant. This so-called destination therapy market is seen as a key growth driver for the heart-pump industry.
Thoratec typically wouldn't comment on trial results from another company's product, Burbach said, speaking at an investor conference Tuesday. However, he said comparisons HeartWare made between the two companies' products weren't founded in scientific evidence.
A representative from HeartWare wasn't immediately available for comment.
Burbach raised questions about the nature of the study's control group, in which patients were mostly treated with Thoratec's HeartMate II. Burbach said the patients in the control group were sicker than the patients in the group treated with HeartWare's device.
He also said that some of the control patients were treated with an older-generation version of Thoratec's pump. And he raised concerns about the way "adverse events" were defined across the two groups. (Dow Jones news)