St. Jude Medical has obtained CE mark approval for its HeartMate 3 left ventricular assist system (LVAS), allowing for the product's marketing in the European Union (EU) region.
The new system is a cardiac support option for advanced heart failure patients who are expected to have a transplantation or are under myocardial recovery.
Claimed to be the first commercially approved centrifugal-flow left ventricular assist device (LVAD), the system uses Full MagLev technology to suspend the device’s rotor through magnetic forces.
HeartMate 3 system’s centrifugal blood pump is implanted directly onto a patient’s native heart, to pump up to 10l of blood per minute.
The approval was granted based on the data of HeartMate 3 CE mark clinical trial that reached its primary endpoint and showed a 92% six-month survival rate.
Completed in November 2014, the study enrolled 50 patients, including both bridge-to-transplant and destination therapy patients, at 10 hospitals in six countries outside the US.
St. Jude Medical group president Dr Eric Fain said: "We are pleased to announce CE Mark approval of the next-generation HeartMate 3 system, which has been proven through the HeartMate 3 CE Mark study to show high survival rates, material improvements in functional status, and very low adverse event rates highlighted by zero pump thrombosis events."
The firm is planning for a limited market release of the system across Europe, and will introduce in additional markets throughout next year.
Last week, St. Jude Medical completed the $3.3bn acquisition of Thoratec, which develops mechanical circulatory support (MCS) technology to treat advanced heart failure.
St. Jude acquired HeartMate II LVAD, CentriMag and PediMag/PediVAS, HeartMate 3 and HeartMate PH from Thoratec.
Image: St. Jude’s HeartMate 3 left ventricular assist system. Photo: courtesy of Business Wire.