Updated February 14th, 2024 at 07:41 IST

FDA advisers support Abbott's heart valve repair device

The panel, in a 13-to-1 vote, affirmed that the benefits of Abbott's TriClip device in treating tricuspid regurgitation (TR) outweigh the associated risks.

Reported by: Business Desk
Abbott heart device | Image:Republic
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Advisers to the US Food and Drug Administration (US FDA) expressed their endorsement for Abbott Laboratories' heart valve repair device on Tuesday, intended for patients facing heightened risks during surgical procedures.

The panel, in a 13-to-1 vote, affirmed that the benefits of Abbott's TriClip device in treating tricuspid regurgitation (TR) outweigh the associated risks. 

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TR occurs when the valve between the heart's right chambers fails to close properly, potentially leading to heart failure.

TriClip, already approved in over 50 countries, including Europe and Canada, addresses TR, a condition prevalent among older individuals with multiple health issues, making traditional open-heart surgery perilous and leaving many untreated.

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Abbott seeks FDA approval for TriClip to enhance the health status of patients with severe TR, where symptoms persist despite medical intervention. 

The application draws on data from late-stage studies demonstrating TriClip's major improvement in patients' quality of life.

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TR affects an estimated 1.6 million Americans, underscoring the importance of TriClip in Abbott's product lineup.

Following the FDA staff's observation last Friday regarding the absence of evidence showing reduced mortality or hospitalisations in TriClip recipients compared to those receiving medical therapy, the advisory panel met.

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However, no new concerns about the device were raised.

Bradley Bart, a voting member and professor of medicine at the University of Minnesota School of Medicine, stressed the limited alternatives available for TR patients, ultimately favouring TriClip's approval.

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The advisers voted 12-2 in favour of the device's effectiveness and unanimously supported its safety. TriClip is akin to Abbott's previous device, MitraClip, which targets the upper and lower chambers of the left side of the heart.

The FDA is anticipated to make its decision later this year.

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(With Reuters Inputs)

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Published February 14th, 2024 at 07:41 IST