First Procedure Performed in Thoratec’s Less-Invasive HeartMate 3 Trial in Europe

Officials with Pleasanton, Calif.-based Thoratec Corp. reported the first-ever HeartMate 3 implant performed via mini-thoracotomy (surgical opening of the chest). 

The implant signals the start of a European study to evaluate outcomes and complications using less-invasive surgical placement through hemi-sternotomy (another surgical approach for chest access) and left thoracotomy techniques. The study will include 10 cases performed at three European centers following one initial case to build experience at each center, and will measure the outcomes specified in the HeartMate 3 CE mark trial after 30 days of follow-up.

HeartMate 3 is a centrifugal-flow chronic left ventricular assist system.  The fully magnetically levitated technology foundation of HeartMate 3 is designed to lower adverse event rates through improved hemocompatibility while enhancing the ease of surgical placement through a compact size. 

“This achievement marks the latest step in our progress with HeartMate 3, and will help build important clinical experience as we validate the surgical versatility of this  new technology,” said D. Keith Grossman, president and CEO of Thoratec.

The first less-invasive surgery with HeartMate 3 was performed at the Institute for Clinical and Experimental Medicine (IKEM) in Prague, Czech Republic, by Ivan Netuka, M.D., Ph.D., deputy head at IKEM and Jan Schmitto M.D., Ph.D., director of the Mechanical Circulatory Support and Cardiac Transplantation Program at the Hannover Medical School in Hanover, Germany.

“The pump design ensured elegant placement in a petite 70-year-old female with body surface area of 1.65 m², and the patient has been discharged from the hospital in a normal post-operative manner.  This demonstrates that HeartMate 3 can accommodate choice in surgical placement. We look forward to confirming an encouraging initial experience in this ongoing trial,” said Netuka.

“The ease of implant, combined with potential for improved clinical outcomes with HeartMate 3, provide for a very attractive next generation device capable of treating a wide range of patients,” Schmitto said.

Earlier this year, the company received final approval from the U.S. Food and Drug Administration (FDA) to broaden enrollment of the HeartMate 3 U.S. clinical trial of up to 1,028 patients in up to 60 sites.

Thoratec’s focus is therapies to address advanced-stage heart failure. The company’s products include the HeartMate II and HeartMate 3 LVAS (left ventricular assist systems) and Thoratec VAD (ventricular assist device) with more than 20,000 devices implanted in patients suffering from heart failure. Thoratec also manufactures and distributes the CentriMag, PediMag/PediVAS, and HeartMate PHP product lines. HeartMate 3 and HeartMate PHP are investigational devices and are limited by U.S. law to investigational use.