FDA Clears TriClip for Tricuspid Regurgitation

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The FDA has approved Abbott’s TriClip Transcatheter Edge-to-Edge Repair system for repairing severe tricuspid regurgitation. The approval was based on positive results from the TRILUMINATE trial, showing significant improvement in quality of life for patients who underwent repair with the TriClip system. The procedure was found to be safe, with a high rate of patients free from major adverse events at 30 days. This approval is seen as a significant advancement for patients with tricuspid regurgitation, offering a safe and effective alternative to high-risk open-heart surgery. TriClip leverages clip-based technology to specifically treat the complex anatomy of the tricuspid valve.

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