By Leroy Leo
(Reuters) – 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 hospitalizations in patients who received the implant compared with those on medical therapy, but did not raise any new concerns about the device.
“It’s important to consider what the alternatives are for these patients and their alternatives are quite limited. So I think overall, the totality is favorable,” said voting member Bradley Bart, who is also a professor of medicine at University of Minnesota School of Medicine.
The advisers voted 12-2 in favor of the effectiveness and unanimously backed safety of the device, which is similar to Abbott’s older device MitraClip that operates in the upper and lower left chambers of the heart.
FDA’s decision is expected later this year.
(Reporting by Leroy Leo and Puyaan Singh in Bengaluru; Editing by Shinjini Ganguli and Sherry Jacob-Phillips)
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