St. Jude Medical Announces CE Mark Approval For HeartMate 3 System

(RTTNews) - St. Jude Medical, Inc. (STJ) announced the company has received CE Mark approval for the HeartMate 3 Left Ventricular Assist System, 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 company said the CE Mark approval 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.

St. Jude Medical expects a limited market release across Europe to begin immediately, with additional market releases taking place throughout 2016. In the U.S., the HeartMate 3 system is in an ongoing IDE trial.