Abbott's heart valve repair device gains US FDA approval

[April 03, 2024]  By Puyaan Singh

(Reuters) -Abbott Laboratories said on Tuesday the U.S. FDA has approved its heart valve repair device for patients with a potentially fatal heart disease, just months after rival Edwards Lifesciences received the regulator's nod for its device.

The Abbott device, TriClip, aims to treat tricuspid regurgitation (TR), which occurs when the valve separating the right lower chamber of the heart from the right upper does not close properly, causing blood to flow backwards.

The condition typically impacts older individuals with multiple co-morbid conditions such as irregular heartbeat and high blood pressure in the lungs or heart who are at high risk of complications or death due to open-heart surgery.

It is estimated about 1.6 million Americans are affected by the condition, according to government data.

In February, Edwards Lifesciences gained approval for a device that replaces the tricuspid valve. Unlike the Edwards rival, Abbott's device repairs the tricuspid valve by clipping a portion of its flaps to reduce the backflow of blood.

Other options to treat the disease include diuretic drugs, which make patients urinate frequently to prevent a buildup of fluid in the body.

Abbott Laboratories logo is displayed on a screen at the New York Stock Exchange (NYSE) in New York City, U.S., October 18, 2021. REUTERS/Brendan McDermid/File Photo

"The key message to remember here is that patients now have options," said Nadim Geloo, Senior Director of Medical Affairs at Abbott's Structural Heart Division.

Geloo said that repairing the valve instead of replacing it is a "very positive treatment path", adding that 98% of the patients who received TriClip had no major adverse events in 30 days.

Abbott counts TriClip, which is already approved in over 50 countries, in its group of so-called "Fab 5" devices, which are expected to drive sales growth in the next few years.

The device is inserted through the femoral vein in the leg and is then guided and clipped onto the tricuspid valve.

(Reporting by Puyaan Singh in Bengaluru; Editing by Shilpi Majumdar, Shinjini Ganguli and Krishna Chandra Eluri)

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