VENUS MEDTECH-B (02500) Submits CE MDR Certification Application for Cardiovalve Transcatheter Tricuspid Valve Replacement System

Stock News2025-12-24

VENUS MEDTECH-B (02500) announced that the group has recently submitted the complete application for CE MDR certification of its Cardiovalve transcatheter tricuspid valve replacement system (Cardiovalve System) to the European Notified Body. The Cardiovalve System is a transcatheter intervention replacement product designed to treat both mitral regurgitation and tricuspid regurgitation. Compared to similar products, the Cardiovalve System's transfemoral venous approach significantly enhances treatment safety. Its large annulus design, with a maximum diameter of 55mm, is suitable for approximately 95% of the patient population. Additionally, the system's unique short-frame design effectively reduces the risk of ventricular outflow tract obstruction. The Cardiovalve System features a simple, safe, and highly reproducible operation, requiring only three steps: positioning, anchoring, and deployment.

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