Valgen Medtech's DragonFly System Receives EU CE Mark Approval for FMR, Achieving Full Indication Coverage for Mitral Regurgitation

HANGZHOU, China — Valgen Medtech announced that its proprietary DragonFly System has officially received CE Mark approval under the European Union Medical Device Regulation (MDR) for the treatment of Secondary/Functional Mitral Regurgitation (FMR).

Following the EU approval for Degenerative Mitral Regurgitation (DMR) in April 2025, this latest milestone makes DragonFly System the first Chinese-developed transcatheter mitral valve repair device to achieve both DMR and FMR in the European Union.

• DragonFly System is the first domestic Chinese device to successfully pass one of the world's most stringent regulatory validation systems for FMR, demonstrating exceptional safety and efficacy in treating complex functional mitral regurgitation.

• Backed by comprehensive multi-center studies across both Western and Eastern patient populations—including the DragonFly DMR, DragonFly FMR, and DragonFly-EU clinical trials—the system provides a robust, global evidence chain of immediate safety and long-term stable efficacy.

• Expanding Global Footprint: To date, DragonFly system has been approved for commercial marketing in 15 countries and regions worldwide, achieving routine clinical application and commercial implants across South America, Southeast Asia, and Europe.

With full EU indication approval, Valgen Medtech will further accelerate its international commercialization pathway, delivering world-class, rigorous, and sustainable original medical technologies to heart failure and structural heart disease patients globally.