St Jude Medical has secured CE Mark approval for its HeartMate 3 left ventricular assist system (LVAS), allowing the product’s marketing in the European Union (EU).
HeartMate 3 is a cardiac support option for advanced heart failure patients who are awaiting transplantation or are under myocardial recovery.
Claimed to be the first commercially approved centrifugal-flow left ventricular assist device (LVAD), the HeartMate 3 system uses Full MagLev technology to suspend the device’s rotor via magnetic forces.
The company noted this design aims to reduce trauma to blood passing through the pump and improve outcomes for patients.
The device includes a centrifugal blood pump that is implanted directly onto a patient’s native heart in order to pump up to ten litres of blood per minute.
It is designed to supplement the pumping ability of the weakened heart’s left ventricle, which is responsible for pumping oxygen-rich blood from the lungs throughout the body.
The CE Mark was granted based on data from the HeartMate 3 CE mark clinical trial in which 50 patients were enrolled, including both bridge-to-transplant and destination therapy patients, at ten hospitals in six countries outside the US.
The trial met its primary endpoint and showed a 92% six-month survival rate.
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.
"Heart failure remains one of the most costly epidemic diseases in the world, and the HeartMate 3 system is critical to supporting physicians managing the care of patients battling such a complex and challenging condition."
The company expects a limited market release of the system across Europe to start immediately, with additional market releases taking place throughout next year.
HeartMate 3 LVAD is comprised of large, consistent blood flow gaps over a wide range of device operation levels, designed to reduce blood trauma.
The system’s artificial pulse technology is designed to further reduce adverse patient events, including combating the formation of thrombus in the device.
Earlier this month, St Jude completed the $3.3bn acquisition of Thoratec, which develops mechanical circulatory support (MCS) technology to treat advanced heart failure.
As part of the transaction, St Jude paid $63.50 per share to Thoratec and acquired HeartMate II LVAD, CentriMag and PediMag/PediVAS, HeartMate 3 and HeartMate PH.
Image: St Jude’s HeartMate 3 left ventricular assist system. Photo: courtesy of Business Wire.