Abbott (NYSE:ABT) announced today that it won FDA breakthrough device designation for its in-development fully implantable left ventricular assist system (Filvas).
According to a news release, left ventricular assist devices are implanted into the body and powered using an external battery pack or charging port. Abbott’s fully implantable device would require no external components, offering more freedom for the patient.
Abbott Park, Ill.-based Abbott’s Filvas is currently in the research & development stage. It is not available for sale anywhere in the world right now.
“As the leader in heart failure management, a fully implantable heart pump has been our vision for the tens of thousands of people who progress into advanced heart failure each year,” senior VP of the Abbott electrophysiology & heart failure division Michael Pederson said in the news release. “The potential for a fully implantable system would mean more freedom and a greater quality of life because there are no external components to be carried everywhere. These advances underscore Abbott’s long-standing commitment to developing innovative devices that allow those with heart failure to live their best lives.”
Abbott currently develops the CE Marked and FDA-approved HeartMate 3 LVAD heart pump for advanced heart failure patients who are awaiting transplantation or are not candidates for transplantation. The company touts it as the first approved LVAD with full MagLev technology, allowing for magnetic “suspension” of the device’s rotor to reduce blood trauma.
In October 2019, Medtronic (NYSE:MDT) announced that it had won breakthrough device designation from the FDA for its fully implantable heart pump. The 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. At the time, Medtronic said the device is still in the early R&D stages and is not on the market anywhere.