Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, today announced that it received final approval from the FDA to broaden enrollment of the HeartMate III U.S. clinical trial of up to 1,028 patients in up to 60 sites. This was based on the FDA's evaluation of safety data from the first ten HeartMate III implants performed in recent months during a limited enrollment phase at five sites.
"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," said D. Keith Grossman, President and Chief Executive Officer. "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.," he added.
HeartMate III is a centrifugal-flow chronic left ventricular assist system, utilizing a fully magnetically levitated technology foundation, designed to lower adverse event rates while also enhancing the ease of surgical placement through a compact size.
Additionally, Thoratec announced that it has named co-principal investigators for the HeartMate III U.S. clinical trial. They are Dr. Mandeep Mehra, Medical Director of the Brigham and Women's Health Heart and Vascular Center, Executive Director of the Center for Advanced Heart Disease, and Professor of Medicine at Harvard Medical School; Dr. Daniel Goldstein, Professor and Vice-Chair of the Department of Cardiothoracic Surgery and Surgical Director of the Mechanical Assistance Program at Montefiore Medical Center; Dr. Nir Uriel, Associate Professor of Medicine and Medical Director of the Heart Failure, Heart Transplant and Mechanical Assist Device Programs of the Division of Cardiology at the University of Chicago; and Dr. Joseph Cleveland Jr., Professor of Surgery and Surgical Director of Cardiac Transplantation and Mechanical Circulatory Support at the University of Colorado Anschutz Medical Center.
The HeartMate III U.S. clinical trial is a randomized non-inferiority study comparing HeartMate III with HeartMate II®™ including a primary endpoint of survival free of device replacement and debilitating stroke. The first 294 randomized patients in the trial 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 superiority of pre-specified secondary endpoints. Outside of the U.S., Thoratec completed enrollment of the HeartMate III CE Mark study in late 2014 and continues to expect a commercial approval and launch in European markets during late 2015.