US-based Thoratec has reported that the first patient has been implanted with its HeartMate III, a centrifugal-flow chronic left ventricular assist system, in a CE Mark clinical trial for the device.
The first human implant of HeartMate III has been carried out at the Hannover Medical School , Germany, which marked the first patient enrolled in the trial.
Around 50 patients are expected to be enrolled in the HeartMate III CE Mark clinical trial at nine sites in Europe, Australia and Canada.
Thoratec president and chief executive officer Gary Burbach said: "We are excited about the potential for HeartMate III to advance heart failure therapy, improve clinical outcomes and enhance the patient experience."
According to Thoratec, 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 implant was carried out under the direction of surgeon Jan Schmitto and professor Axel Haverich, chief of the Hannover Medical School’s Cardiothoracic, Transplantation and Vascular Surgery Department.
The trial includes a primary endpoint of six-month survival compared with estimated mortality based on the Seattle Heart Failure Model.
As well as the first implant carried out in Germany, patient enrolment in the HeartMate III CE mark trial has also started at the Vienna Medical University in Vienna, Austria.
In Austria, the trial is being conducted under the supervision of mechanical circulatory support director Daniel Zimpfer and department of cardiac surgery head Gunther Laufer.
Thoratec’s products include the HeartMate II and HeartMate III LVAS (Left Ventricular Assist Systems) and Thoratec VAD (Ventricular Assist Device) with over 20,000 devices implanted in patients suffering from heart failure.
The company also manufactures and distributes the CentriMag and PediMag/PediVAS product lines.