FDA OKs Expansion of Thoratec’s HeartMate III Trial in U.S.

Pleasanton, Calif.-based Thoratec Corp., which makes mechanical circulatory support devices, received final approval from the U.S. Food and Drug Administration (FDA) to broaden enrollment of the HeartMate III U.S. clinical trial of up to 1,028 patients in up to 60 sites.

This decision was based on the FDA’s evaluation of safety data from the first 10 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 CEO of Thoratec. “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.”

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

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. 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 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.

Thoratec’s products include the HeartMate II Left Ventricular Assist Systems and Thoratec Ventricular Assist Device. The company also manufactures the CentriMag and PediMag/PediVAS product lines.