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Abbott's heart valve repair device gets US approval
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Abbott's heart valve repair device gets US approval
Apr 2, 2024 7:39 AM

April 2 (Reuters) - Abbott Laboratories ( ABT ) said on

Tuesday the U.S. FDA has approved its heart valve repair device

designed for patients at risk of complications or death during

open-heart surgeries.

The device, TriClip, already approved in over 50 countries,

aims to treat tricuspid regurgitation (TR), a potentially fatal

condition where the valve separating the right lower chamber of

the heart from the right upper does not close properly.

The condition typically impacts older individuals with

multiple co-morbid conditions such as irregular heartbeat and

high blood pressure in the lungs or heart.

The Abbott device can offer patients an option "without

subjecting them to high-risk open-heart surgery that may not be

feasible for individuals with TR who are generally older and

sicker," said Paul Sorajja, co-principal investigator of the

device's late-stage trial.

The device is inserted through the femoral vein in the leg

and is then guided and clipped onto the tricuspid valve.

In February, Edwards Lifesciences ( EW ) rival device for the

condition was approved by the U.S. Food and Drug Administration,

around the same time when advisers to the health regulator

backed Abbott's device.

Abbott counts TriClip in its group of so-called "Fab 5"

devices, which are expected to drive sales growth in the coming

years.

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