China-based Valgen Medtech has announced that its proprietary DragonFly Transcatheter Mitral Valve Repair System has received CE mark approval in the European Union for the treatment of Functional Mitral Regurgitation (FMR).
The latest approval follows the device’s EU authorization for Degenerative Mitral Regurgitation (DMR) in April 2025, making DragonFly the first transcatheter mitral valve repair system developed in China to secure EU approval for both DMR and FMR indications.
Mitral regurgitation (MR) is among the most common valvular heart diseases globally. Functional Mitral Regurgitation, often associated with heart failure, remains particularly challenging to treat in clinical practice.
According to Valgen Medtech, the DragonFly System is supported by clinical evidence from multiple multicenter studies conducted across Asia, Europe, and other international markets, including the DragonFly-DMR, DragonFly-FMR, and DragonFly-EU pivotal trials.
One-year follow-up data from the DragonFly-DMR EU Pivotal Study, presented at CSI Frankfurt 2026, showed positive outcomes in terms of safety, durability, and clinical performance among elderly patients with severe DMR who were considered high-risk for surgery.
To date, DragonFly has obtained regulatory approvals across 15 countries and regions, with commercial adoption and routine clinical use already established in key international markets, including Latin America and Southeast Asia.
