Fully implantable LV assist system designated breakthrough device
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Abbott announced its fully implantable left ventricular assist system received a breakthrough device designation from the FDA.
According to a press release from the company, current LV assist devices are implanted into the body yet require power from an external battery or charging port, but that would not be the case with the new system.
“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,” Michael Pederson, senior vice president for Abbott’s electrophysiology and heart failure division, said in the release. “These advances underscore Abbott’s longstanding commitment to develop innovative devices that allow those with heart failure to live their best lives.”
The system is currently in development and not available for sale anywhere in the world. It is the second fully implantable LVAD to receive FDA’s breakthrough device designation, following one from Medtronic, as Healio previously reported.
Disclosures: Pederson is an employee of Abbott.