Abbott’s heart valve repair device gets FDA advisers’ backing

Feb 14,2024

Bengaluru: Advisers to the U.S. Food and Drug Administration on Tuesday backed an approval for Abbott Laboratories ' heart valve repair device that is designed for patients who are at risk of complications or death during surgery.

The panel voted 13-to-1 in favor of the benefits of using TriClip  in tricuspid regurgitation (TR) outweighing the risks. In TR, the valve separating the right lower chamber of the heart from the right upper does not close properly, which can potentially cause heart failure.

TriClip is approved in more than 50 countries, including Europe and Canada , for treating TR, which typically impacts older individuals who have multiple co- morbidities, making open-heart surgery a high-risk procedure and resulting in many people going untreated.

Abbott is seeking FDA approval for TriClip for improving the health status in patients with severe TR, which means symptoms persist despite medical therapy.

Its application is based on data from a late-stage study that showed TriClip significantly improved patients' quality of life.

The condition is estimated to affect about 1.6 million Americans, according to government data, making the device a key product in Abbott's pipeline.

FDA's advisory panel meet followed the agency's staff on Friday noting the lack of signs of reduced deaths or hospitalisations in patients who received the implant compared with those on medical therapy, but did not raise any new concerns about the device.

Source: Healthworld