Mitral Valve Repair Device Receives EU Approval for Functional Regurgitation

International guidance has recently elevated transcatheter repair for carefully selected patients, including a 2025 European Class I recommendation and an Asia‑Pacific pathway issued in April 2026. A newly approved system now offers European clinicians a CE‑marked option for treating FMR.

Valgen Medtech’s DragonFly Transcatheter Mitral Valve Repair System has received CE mark approval in the European Union for the treatment of FMR. This follows its EU approval for degenerative mitral regurgitation (DMR) granted in April 2025. With the new indication, DragonFly is the first transcatheter mitral valve repair device originating in China to hold EU approval for both DMR and FMR.

The DragonFly System is a transcatheter platform designed for mitral valve repair. Trial experience reported by the company indicates high technical reliability, with device implantation and procedural success rates of 97.4% in an elderly, high‑risk DMR cohort; two‑thirds of patients in that study were treated with a single clip. These data reflect the system’s clip‑based approach to percutaneous mitral repair while formal FMR outcomes will be clarified as additional evidence becomes available.

The device’s evidence base includes multicenter studies across Asia, Europe, and other regions, encompassing the DragonFly‑DMR, DragonFly‑FMR, and DragonFly‑EU pivotal trials. One‑year follow‑up from the DragonFly–DMR EU Pivotal Study, presented at CSI Frankfurt 2026, showed that 100% of patients maintained mitral regurgitation at moderate or less (≤2+). The composite primary effectiveness endpoint—freedom from all‑cause mortality, mitral valve reintervention, and MR greater than 2+—was achieved in 86.7% of patients. By 30 days, 100% had improved to New York Heart Association (NYHA) Class I or II, with these functional gains sustained through one year, alongside favorable cardiac reverse remodeling.

According to the company, DragonFly now holds regulatory approvals in 15 countries and regions, with routine clinical use and commercial adoption reported in markets including Latin America and Southeast Asia. The EU authorization for FMR aligns with recent international movements that clarify patient selection and management pathways for transcatheter edge‑to‑edge repair (TEER). These developments collectively expand options for heart teams treating complex FMR.