TRiCares Announces Initiation of TRICURE US IDE Pivotal Study for Topaz Tricuspid Valve Replacement System

TRiCares has enrolled the first patient in its TRICURE US IDE pivotal study for the Topaz tricuspid valve replacement system, marking the first randomized controlled trial comparing an investigational TTVR device against Edwards' commercially available EVOQUE system. The global study will involve up to 75 sites across the US, Canada, and Europe, with the goal of demonstrating safety and effectiveness for treating severe tricuspid regurgitation.