News | Heart Failure | March 05, 2020

Abbott’s In-Development Fully Implantable Heart Pump System Earns FDA’s Breakthrough Device Designation


March 5, 2020 — Abbott recently received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Fully Implantable Left Ventricular Assist System (FILVAS) currently in development. 

The FDA launched the Breakthrough Devices Program in 2018 to help expedite the development and review of submissions for technology that offers significant advantages over existing approved products.

Approximately 6.2 million people in the U.S. are living with heart failure. Because this is a progressive disease, more than 600,000 people each year reach an advanced stage where traditional therapies, such as medication and cardiac resynchronization therapies, no longer work.

“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.”

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.

Abbott’s FILVAS is in research and development and is not available for sale anywhere in the world. 

Related Content

News | Artificial Heart

June 18, 2021 – An experimental artificial heart includes an autoregulation control mechanism, or Auto-Mode, that can ...

Home June 23, 2021
Home
News | Artificial Heart

February 10, 2021 - The U.S. Food and Drug Administration (FDA) has granted artificial heart developer Carmat approval ...

Home February 10, 2021
Home
News | Artificial Heart

May 27, 2020 — Carmat, a developer of the of a next generation advanced total artificial heart, announces the first ...

Home May 27, 2020
Home
News | Artificial Heart

March 10, 2020 — The U.S. Food and Drug Administration (FDA) has cleared the SynCardia Systems 50cc temporary Total ...

Home March 10, 2020
Home
News | Artificial Heart

December 11, 2017 — CorInnova Inc. recently announced it was awarded second prize in the “2017 InnoSTARS” life science ...

Home December 11, 2017
Home
News | Artificial Heart

October 27, 2017 — CorInnova Inc. announced it has received notice of allowance of a seminal patent to protect its ...

Home October 27, 2017
Home
News | Artificial Heart

October 26, 2016 — The U.S. Food and Drug Administration (FDA) provided an update and additional information regarding ...

Home October 26, 2016
Home
News | Artificial Heart

August 29, 2016 — SynCardia Systems, manufacturer of the Total Artificial Heart (TAH), announced that the judge ...

Home September 13, 2016
Home
News | Artificial Heart

September 9, 2016 — Carmat announced that the first implantation of its bioprosthetic artificial heart within the ...

Home September 09, 2016
Home
News | Artificial Heart

March 24, 2016 — A new documentary produced by Retro Report for The New York Times looks at the history and modern use ...

Home March 24, 2016
Home
Subscribe Now