The Pleasanton, Calif.-based medical device company won an investigational device exemption to enroll up to 100 patients with NYHA Class III heart failure, comparing treatment with either the HeartMate II device or "optimal medical management," which is currently the gold standard of treatment for those patients.
Thoratec has committed a R&D budget of up to $11 million over 5 years in support of the study, president & CEO Gary Burbank told an audience at the J.P. Morgan Healthcare conference in San Francisco today.
"I think it’s a strong vote of confidence in the HeartMate II and its performance by the FDA, as well as the investigators that we’re working with," Burbank said. "There is a funding commitment that we’ve made which could be up to $11 million, which will span about 5 years over the course of this study."
The National Institutes of Health are the lead sponsor of the study, Burbank noted. The NIH’s National Heart, Lung & Blood Institute committed to a $5 million contract, and the University of Michigan, University of Pittsburgh and "a number of other luminary institutions" are also supporting of the trial, he said.
The HeartMate II device is designed to help the heart’s pumping action in patients with severe heart disease and for use in people awaiting a heart transplant.
The FDA cleared HeartMate II in January 2010 as a so-called "destination therapy," implanted indefinitely in people who aren’t eligible for a new heart and are too sick to undergo surgery..
Last month Thoratec won approval to launch the device in Japan. The company is now navigating the Japanese reimbursement process and expects to launch in late Q1 2013, Burbank said today.