Abbott has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development Fully Implantable Left Ventricular Assist System (FILVAS).
"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," says Michael Pederson, senior vice president for Abbott's electrophysiology and heart failure division. "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 develop innovative devices that allow those with heart failure to live their best lives."
Heart pumps are small, implantable mechanical devices that pump blood throughout the body in people living with advanced heart failure. Those living with a heart pump are either waiting for a heart transplant or aren’t candidates for a heart transplant, and need the life-saving device to pump blood from their heart to the rest of their body. Currently, left ventricular assist devices (LVADs) are implanted into the body and then powered using an external battery pack or charging port.
Abbott's FILVAS is in research and development and is not available for sale anywhere in the world.