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TRiCares starts US pivotal trial for Topaz tricuspid valve replacement system.

Company Fundamentals
09 Jul 2026
Tricares Sas
View Source
Bullish
pluang ai news

TRiCares has initiated the US pivotal IDE study for its Topaz Transcatheter Tricuspid Valve Replacement (TTVR) system, marking the first randomized trial comparing it head-to-head with the Edwards EVOQUE system. This global, multi-center study aims to evaluate the safety and effectiveness of Topaz in patients with severe tricuspid regurgitation, involving up to 75 sites across the US, Canada, and Europe. The study's start is a key step toward FDA approval and wider adoption of Topaz as a minimally invasive alternative to open-heart surgery for tricuspid valve replacement. Ongoing parallel studies in Europe and early feasibility studies in the US and Canada support the clinical development of Topaz.

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