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An FDA advisory panel voted 13 to 1 that the benefits of Abbott's first-of-its-kind transcatheter system to treat tricuspid regurgitation outweigh any potential risks.
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.
Committee voted 13-1 that the benefits of the TEER device outweigh the risks in certain patients