Thoratec (NSDQ:THOR) today said the FDA approved an expansion of the clinical trial for its next-generation implantable heart pump, the HeartMate III, after evaluating the safety data from 10 initial patients.
The HeartMate III trial can now be expanded to enroll as many as 1,028 patients at up to 60 sites, Pleasanton, Calif.-based Thoratec said.
The trial is a a randomized, non-inferiority study designed to compare HeartMate III with the HeartMate II device, including a primary endpoint of survival free of device replacement and debilitating stroke. The 1st 294 patients are slated to be followed for 6 months to evaluate a short-term indication such as bridge-to-transplantation; the 1st 366 randomized patients will be followed for 24 months to evaluate a long-term indication such as destination therapy, Thoratec said.
Another 600 subjects can be enrolled beyond the trial’s pivotal phase "to assess superiority of pre-specified secondary endpoints," according to the company. Thoratec launched the U.S. trial last September.
Late last year Thoratec closed enrollment in a European trial of the HeartMate III device ahead of a bid for CE Mark approval there. Today the company said it expects to launch HeartMate III overseas late this year.
"We are very pleased to reach this most recent milestone with our HeartMate III clinical program, along with the increasing enthusiasm for our latest product advancements," president & CEO Keith Grossman said in prepared remarks. "Building on our recent success with rapid enrollment in the HeartMate III CE Mark study, we look forward to bringing this differentiated technology to 60 of the most active implanting centers throughout the U.S."
Thoratec also named the 4 co-principal investigators for the U.S. trial: Dr. Mandeep Mehra of Boston’s Brigham & Women’s Hospital; Dr. Daniel Goldstein of New York’s Montefiore Medical Center; Dr. Nir Uriel of the University of Chicago; and Dr. Joseph Cleveland Jr. of the University of Colorado Anschutz Medical Center.