www.fdanews.com/articles/173547-st-jude-receives-ce-mark-for-heart-failure-device
St. Jude Receives CE Mark for Heart Failure Device
October 12, 2015
St. Jude Medical has received CE mark approval for its HeartMate 3 left ventricular assist system.
The system offers a cardiac support option for advanced heart failure patients who are awaiting transplantation, aren’t candidates for heart transplantation, or are recovering from a heart attack, the St. Paul, Minn.-based company says.
The device is implanted above the diaphragm and attached to the aorta, providing sufficient energy to pump blood throughout the body.
Receipt of the CE mark followed a clinical trial showing the HeartMate 3 LVAS met its primary endpoint of 92 percent survival at six months. — Michael Cipriano