June 29, 2016 — St. Jude Medical Inc. recently announced the company received an Innovation Award for its HeartMate 3 Left Ventricular Assist System (LVAS) at the 2016 CardioStim EHRA Europace International Congress of electrophysiology and cardiac technology.
Each year, an international panel of experts, scientists and physicians gather to review the latest in medical technology. The HeartMate 3 LVAS was awarded in the category of Patient Care Improvement. The circulatory assist device is available to heart failure patients as a cardiac support option for advanced heart failure patients who are awaiting transplantation, are not candidates for heart transplantation or are in myocardial recovery.
“The CardioStim Innovation Awards aim at honoring the performance, achievement and cutting-edge technologies designed by manufacturers that are created to modernize medical practice and improve patient care,” said Philippe Ritter, M.D., chairman of CardioStim and heart rhythm specialist at the University Hospital of Bordeaux, France. “The HeartMate 3 cardiac assist device brings real benefit to patients suffering from heart failure and is an encouraging solution, in particular, for those awaiting transplantation.”
HeartMate 3 is the first commercially approved centrifugal-flow left ventricular assist device (LVAD) utilizing Full MagLev technology, which allows the device’s rotor to be “suspended” by magnetic forces. This design aims to reduce trauma to blood passing through the pump and improve outcomes for patients.
CE Mark approval for the HeartMate 3 LVAS was based on data from the HeartMate 3 CE Mark clinical trial, which met its primary endpoint and demonstrated a 92 percent six-month survival rate, the best six-month survival rate to date to be documented in an LVAD CE Mark clinical study. Enrollment included both bridge-to-transplant and destination therapy patients in New York Hospital Association (NYHA) Class IIIb or IV heart failure.
In the United States, the HeartMate 3 LVAS is in an ongoing investigational device exemption (IDE) trial. The MOMENTUM 3 IDE trial, the largest of its kind, remains ongoing and will enroll more than 1,000 patients. The device is not approved in the United States and limited by federal law to investigational use.
For more information: www.sjm.com
