Thoratec announced that the first patient has been implanted with its HeartMate III, a centrifugal-flow chronic left ventricular assist system, in the CE Mark clinical trial for the device.
The first human implant of HeartMate III has been performed at the Hannover Medical School in Hannover, Germany. This implant marked the first patient enrolled in the HeartMate III CE Mark clinical trial.
The HeartMate III CE Mark study 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.
Enrollment in the HeartMate III CE Mark trial has also been commenced at the Vienna Medical University in Vienna, Austria.
Thoratec has designed the fully magnetically levitated technology foundation of HeartMate III to lower adverse event rates through improved hemocompatibility, while enhancing ease of surgical placement through a compact size.
Thoratec president and CEO Gary Burbach said that the company is pleased to reach this significant clinical milestone with an important pipeline product.
"We are also excited about the potential for HeartMate III to advance heart failure therapy, improve clinical outcomes and enhance the patient experience," Burbach added.