Abbott gains FDA breakthrough device designation status for implantable heart failure solution

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Abbott gains FDA breakthrough device designation status for implantable heart failure solution

John R. Fischer, Senior Reporter | February 06, 2020
Cardiology Operating Room
Abbott has gained FDA breakthrough designation status for its Fully Implantable Left Ventricular Assist System
Abbott has scored a breakthrough device designation from the FDA for its Fully Implantable Left Ventricular Assist System (FILVAS).

Currently still in development, the left ventricle assist device (LVAD) will be designed for patients living with heart failure but spare them the hassles that come with using current heart pump technology.

“People living with an LVAD today have to care for the site on his or her skin where the electrical power cable exits the body to make sure it doesn’t get infected,” Kevin Bourque, divisional vice president of research and development for Abbott’s Mechanical Circulatory Support portfolio, told HCB News. “Additionally, people living with an LVAD also have to carry external batteries and a system controller everywhere they go. The only alternate is to be tethered to a cable plugged into the wall.”

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Approximately 6.2 million people in the U.S. live with heart failure, with more than 600,000 reaching an advanced stage each year where traditional therapies, such as medication and cardiac resynchronization, no longer work.

FILVAS requires no external components, enabling patients to not be completely tethered and to not have to carry any external equipment. The result for patients is more freedom and a greater quality of life, according to Bourque.

“Having to continuously carry external equipment is a lifestyle disadvantage that everyone can appreciate,” he said. “We are focused on continuing to drive such deterrents out of this lifesaving technology.”

The FDA also recently approved the use of Abbott's HeartMate 3 LVAD solution through a less invasive approach than open-heart surgery.

FILVAS is currently in research and development, and not yet available for sale anywhere in the world.

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