Thoratec Announces Start Of Heartmate III™ U.S. Clinical Trial

PLEASANTON, Calif. -- Thoratec Corporation, a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, announced today that it has begun to enroll patients in the HeartMate III™ U.S. clinical trial. 

"We are excited to continue our recent pipeline progress with the start of the U.S. clinical trial for HeartMate III," said Gary F. Burbach, President and Chief Executive Officer.  "Our innovative U.S. trial design allows for the evaluation of patients for both short-term and long-term support, and we are particularly enthusiastic about the potential for HeartMate III to drive future growth of both the LVAD market and Thoratec," he added.

HeartMate III is a centrifugal-flow chronic left ventricular assist system.  The fully magnetically levitated technology foundation is designed to lower adverse event rates through improved hemocompatibility, while HeartMate III also enhances ease of surgical placement through a compact size.  In addition to the current U.S. IDE trial, patient enrollment continues in the HeartMate III CE Mark clinical trial, which began in June. 

James Long M.D. Ph.D., Director of INTEGRIS Advanced Cardiac Care and Medical Director of the Nazih Zuhdi Transplant Institute at INTEGRIS Baptist Medical Center in Oklahoma City, Oklahoma performed the first HeartMate III implant in the U.S.  Dr. Long and his team have a well-established history of innovation in mechanical circulatory support, including participation in clinical trials for every previous HeartMate technology.  "We look forward to further enrollment in this important study for the field, and the opportunity to demonstrate the potential benefits of the unique fully magnetically levitated technology of HeartMate III," commented Dr. Long.  Additionally, Douglas Horstmanshof M.D., Co-Director of INTEGRIS Advanced Cardiac Care at INTEGRIS Baptist Medical Center added, "HeartMate III represents an exciting technology with the potential to advance the treatment of heart failure and improve quality of life for the large number of untreated patients that could benefit from chronic circulatory support."

The HeartMate III U.S. clinical trial is a randomized non-inferiority study comparing HeartMate III with HeartMate II®™ and includes a primary endpoint of survival free of device replacement and debilitating stroke.  The trial began enrollment in a safety phase under conditional approval from the FDA for 30 patients at five sites.  Enrollment will broaden to up to 60 sites following full approval from the FDA based on 30-day follow-up data from the initial safety phase.  The first 294 randomized patients will be followed for six months to evaluate a short-term indication such as Bridge-to-Transplantation.  The first 366 randomized patients will be followed for 24 months to evaluate a long-term indication such as Destination Therapy.  The trial also allows for approximately 600 additional randomized patients to be enrolled beyond the pivotal cohort in order to assess secondary endpoints.

Source: Thoratec Corporation