St. Jude Medical (NYSE:STJ) said today that its newly acquired HeartMate 3 implantable heart pump won CE Mark approval in the European Union, less than a week after the medical device company closed its $3 billion acquisition of Thoratec.
HeartMate 3, a left ventricular assist device, is designed for heart failure patients who are awaiting a transplant, aren’t eligible for a transplant or are in myocardial recovery, Little Canada, Minn.-based St. Jude said. The device is the 1st centrifugal-flow LVAD to use fully magnetically levitated rotor technology, which the company said is designed to reduce the trauma to blood cells as they pass through the pump. This is thought to help lower the risk of blood clots.
St. Jude said it’s planning an immediate but limited release across Europe and expects to enter more throughout 2016.
“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,” group president Dr. Eric Fain said in prepared remarks. “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 advanced heart failure medical community has eagerly anticipated the expected clinical improvements with the HeartMate 3 system and looks forward to its broad adoption throughout Europe,” added Dr. Friedhelm Beyersdorf of the Heart Center Freiburg University.d
St. Jude closed the $3.3 billion Thoratec buyout Oct. 8, a day after the implantable heart pump maker’s shareholders approved the $63.50-per-share deal. The HeartMate 3 device is in an investigational device exemption trial in the U.S., Momentum 3, that’s slated to enroll more than 1,000 patients.
STJ shares were up 2.0% to $65.24 in mid-morning trading today.