HeartMate III™ CE Mark Trial Starts with First Human Implant

Mechanical circulatory support system developer, Thoratec Corporation, has started its CE Mark Clinical Trial for HeartMate III™ and has seen a first patient implanted with the new device.

Background

In early May Thoratec’s financial results suggested its HeartMate franchise was doing pretty well, showing 7% year on year revenue growth. At the time of that release the company was sounding optimistic about its product pipeline, including the next generation HeartMate III system.

HeartMate III is a centrifugal-flow chronic left ventricular assist system. The company says its fully magnetically levitated technology underpinning 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.

Physician comments

“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.

Company comments

“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.”

Source: Thoratec Corporation, PR Newswire

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