VENUS MEDTECH-B (02500) surged over 4%, reaching HK$2.48 by the time of writing, with a trading volume of HK$1.1562 million. The company announced that it has formally submitted the complete application for CE MDR certification of its Cardiovalve transcatheter tricuspid valve replacement system (Cardiovalve System) to a European notified body. This marks a critical step toward the product's market entry in Europe.

The Cardiovalve System is a transcatheter intervention product designed to treat both mitral and tricuspid regurgitation. Compared to similar products, its transfemoral venous approach significantly enhances treatment safety. With a large annulus design of up to 55mm, it accommodates approximately 95% of patients. Additionally, its unique short-frame design effectively reduces the risk of ventricular outflow tract obstruction. The Cardiovalve System is simple, safe, and highly reproducible, requiring only three steps: positioning, anchoring, and deployment.