HeartMate 3 LVAD receives CE mark approval in EU for heart transplant patients- St Jude Medical

St Jude Medical has received CE Mark approval for the HeartMate 3 Left Ventricular Assist System (LVAS), a cardiac support option for advanced heart failure patients who are awaiting transplantation, are not candidates for heart transplantation, or are in myocardial recovery.

CE Mark approval for the HeartMate 3 system was based on data from the HeartMate 3 CE Mark clinical trial, which met its primary endpoint and demonstrated a 92% survival rate at six months; the best six month survival rate to date to be documented in an LVAD CE Mark clinical study. St Jude Medical expects a limited market release across Europe to begin immediately, with additional market releases taking place throughout 2016. The design of the HeartMate 3 LVAD includes large, consistent blood flow gaps over a wide range of device operation levels, designed to reduce blood trauma. The artificial pulse technology is designed to further reduce adverse patient events including combatting the formation of thrombi in the device.