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.
The assessment comes ahead of the FDA's independent expert panel meeting on Tuesday, which will make recommendations on whether or not to clear the use of the device, TriClip, in patients with tricuspid regurgitation (TR). TR is a disorder in which the tricuspid valve that separates the right lower heart chamber from the right upper heart chamber does not close tight enough, potentially causing heart failure.
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