Medtronic (NYSE:MDT) said today that it won breakthrough device designation from the FDA for its fully implantable heart pump.
The Fridley, Minn.-based medical device giant said its left ventricular assist device is designed to be fully implanted inside the body, with no driveline extending outside the body.
Medtronic said the device is still in the early R&D stages and is not on the market anywhere.
The world’s largest medical device outfit got into the LVAD game with the $1.1 billion acquisition of HeartWare in August 2016, which cleared the field of the two major cardiac assist device companies after cross-town rival St. Jude Medical paid $3 billion for Thoratec in October 2015. (St. Jude was later acquired by Abbott for $25 billion).