Thoratec Announces Enrollment Initiation in HeartMate II Trial

Thoratec said that the first patients have been enrolled in the destination therapy and bridge-to-transplantation arms of the Phase II pivotal trial for its HeartMate II LVAS (left ventricular assist system) device.

The HeartMate II is a next-generation heart-assist device designed to provide long-term cardiac support for patients who are in end-stage heart failure. Thoratec said that several of the participating centers have received institutional review board approval to participate in the study. The company said it plans to provide the next update on the trial during its first quarter conference call in late April.

"We are delighted that enrollment has begun less than a month after receiving FDA approval to initiate this phase of the trial," said Thoratec President and CEO D. Keith Grossman. "Our centers remain extremely enthusiastic about advancing the clinical trial of the HeartMate II technology."