FDA Approves Full Expansion of Thoratec's HeartMate III IDE Trial

April 2, 2015—Thoratec Corporation announced that it received final approval from the US Food and Drug Administration (FDA) to broaden enrollment of the HeartMate III United States clinical trial of up to 1,028 patients in up to 60 sites. The approval was based on the FDA’s evaluation of safety data from the first 10 HeartMate III implantations performed in recent months during a limited enrollment phase at five sites.

Thoratec also announced that the coprincipal investigators for the HeartMate III United States clinical trial are Mandeep Mehra, MD; Daniel Goldstein, MD; Nir Uriel, MD; and Joseph Cleveland, Jr, MD.

According to the company, HeartMate III is a centrifugal-flow chronic left ventricular assist system that uses a fully magnetically levitated technology foundation, which is designed to lower adverse event rates while enhancing the ease of surgical placement through a compact size. 

The HeartMate III United States clinical trial is a randomized noninferiority study comparing HeartMate III with the company’s HeartMate II. The primary endpoint is survival with no device replacement or debilitating stroke. The first 294 randomized patients in the trial will be followed for 6 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 prespecified secondary endpoints. 

Outside of the United States, 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.

Coprincipal investigator Dr. Mehra is 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 in Boston, Massachusetts. Dr. Goldstein is Professor and Vice Chair of the Department of Cardiothoracic Surgery and Surgical Director of the Mechanical Assistance Program at Montefiore Medical Center in New York, New York. Dr. Uriel is 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 in Chicago, Illinois. Dr. Cleveland is Professor of Surgery and Surgical Director of Cardiac Transplantation and Mechanical Circulatory Support at the University of Colorado Anschutz Medical Center in Denver, Colorado.