FDAnews
www.fdanews.com/articles/165552-thoratec-implants-first-heartmate-iii-vas-in-germany

Thoratec Implants First HeartMate III VAS in Germany

June 30, 2014

Pleasanton, Calif., devicemaker Thoratec announced Friday the first patient implant of its HeartMate III centrifugal-flow chronic left ventricular assist system — marking the launch of the company’s CE mark clinical trial.

The procedure took place at Hannover Medical School in Germany, Thoratec said. Patient enrollment has also begun at the Vienna Medical University in Austria. In all, the trial will enroll 50 patients across nine sites in Europe, Australia and Canada.

According to Thoratec, HeartMate III is designed to enhance patient compatibility and reduce the risk of adverse events with magnetic levitation, improved hemocompatibility and a compact size that facilitates implantation.

Thoratec plans to initiate a U.S. trial of HeartMate III later this year, after which it will seek FDA approval for the device. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.