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P&F secures FDA approval for TRICAV II pivotal clinical trial for severe tricuspid regurgitation
The TRICAV II trial will test the TricValve system versus medical therapy for 1.6 million U.S. patients with severe tricuspid regurgitation, many ineligible for surgery.
- On Dec. 12, 2025, the U.S. Food and Drug Administration approved initiation of the TRICAV II pivotal trial, advancing its U.S. clinical development from Wilmington, Del.
- Many patients are poor surgical candidates due to frailty or comorbidities, and severe tricuspid regurgitation affects 1.6 million people in the United States.
- The TRICAV II trial will test the TricValve Transcatheter Bicaval Valve System plus optimal medical therapy versus OMT alone in a randomized, controlled study under IDE# G240065.
- The device already has CE‑mark and global use: TricValve is CE‑marked, commercially available in approximately 70 countries with more than 3,000 patients treated, and Samir Kapadia, M.D., said it's "an important advancement."
- The announcement said TRICAV II offers new hope for patients lacking surgical or transcatheter options, according to the P+F Products and Features press release.
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Leaning Left7Leaning Right4Center17Last UpdatedBias Distribution61% Center
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