Abbott’s breakthrough fully implantable heart pump for patient with advanced heart failure

Abbott received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its in-development Fully Implantable Left Ventricular Assist System (FILVAS).

FILVAS builds on the HeartMate 3 Left Ventricular Assist Device (LVAD). The technology was inherited by St. Jude Medical when it was acquired by Abbott. St. Jude inherited Heartmate 3 after it acquired Thoratec for $3.4 billion.

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 are not 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 are implanted into the body and then powered using an external battery pack or charging port. 

“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,” said 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.”

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Millions in the world are living with heart failure. Because this is a progressive disease, people each year reach an advanced stage where traditional therapies, such as medication and cardiac resynchronisation therapies, no longer work.

Abbott has been building up its cardiovascular offerings. Recently the company won CE mark for the Tendyne Transcatheter Mitral Valve Implantation (TMVI) system. Last week, Abbott received FDA approval to conduct a new trial designed to assess the Amplatzer Amulet Left Atrial Appendage (LAA) Occluder for people with atrial fibrillation (AFib).

Abbott’s FILVAS is in research and development and is not yet available for sale.

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