Thoratec commences CE Mark Clinical Trial for HeartMate III chronic left ventricular assist system

Thoratec Corporation (NASDAQ: THOR), a world leader in device-based mechanical circulatory support therapies to save, support and restore failing hearts, said today that its CE Mark Clinical Trial for HeartMate III™ commenced with the first patient implanted with this new device.

"We are pleased to reach this significant clinical milestone with an important pipeline product," said Gary F. Burbach, President and Chief Executive Officer. "We are also excited about the potential for HeartMate III to advance heart failure therapy, improve clinical outcomes and enhance the patient experience," he added.

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

The Hannover Medical School in Hannover, Germany performed the first human implant of HeartMate III under the direction of surgeon Jan Schmitto, M.D., Ph.D. and Professor Axel Haverich M.D., chief of the Cardiothoracic, Transplantation and Vascular Surgery Department at the Hannover Medical School. "I am highly enthusiastic about the potential for HeartMate III based on its elegant implant technique and the promise of improved clinical outcomes," commented Dr. Schmitto. This implant marked the first patient enrolled in the HeartMate III CE Mark Clinical Trial, which will enroll up to 50 patients at nine sites in Europe, Australia, and Canada. The study includes a primary endpoint of six-month survival compared with estimated mortality based on the Seattle Heart Failure Model.

In addition to the first implant performed by Dr. Schmitto in Hannover, Germany, enrollment of the HeartMate III CE Mark Trial has also commenced at the Vienna Medical University in Vienna, Austria with an implant under the direction of Daniel Zimpfer M.D., Director of Mechanical Circulatory Support and Professor Gunther Laufer M.D., Head of the Department of Cardiac Surgery. "We are very pleased to participate in this important study that will help to advance the field of mechanical circulatory support with next generation LVAD technology from Thoratec," said Dr. Zimpfer.