Valgen Medtech's DragonFly™ System Receives EU Approval for FMR Indication
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). This follows earlier EU approval for Degenerative Mitral Regurgitation (DMR) obtained in April 2025. With this latest authorization, the DragonFly™ System becomes the first transcatheter mitral valve repair device from China to be approved in the EU for both DMR and FMR indications.
Mitral regurgitation (MR) is one of the most prevalent valvular heart diseases globally, with FMR frequently occurring in patients experiencing heart failure. Recent international guidelines have begun to address optimal treatment strategies for this complex condition. In 2025, the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) updated their guidelines to classify transcatheter edge-to-edge repair (TEER) for selected patients with ventricular FMR as a Class I recommendation, which signifies the highest level of endorsement.
Additionally, in April 2026, the Asia Pacific Society of Cardiology (APSC) published a consensus statement in JACC: Asia, outlining a standardized treatment pathway and long-term management strategy for symptomatic patients with moderate-to-severe or more advanced FMR who qualify for TEER therapy.
The DragonFly™ System is backed by substantial clinical evidence from a range of multicenter studies conducted in Asia, Europe, and other regions, including the DragonFly-DMR, DragonFly-FMR, and DragonFly-EU pivotal trials. The one-year follow-up results from the DragonFly–DMR EU Pivotal Study, shared by Valgen Medtech at CSI Frankfurt 2026, indicate favorable safety, durability, and clinical performance in elderly patients with severe DMR who are at high surgical risk. Notably, at the one-year follow-up, 100% of patients maintained MR severity at ≤2+ (moderate or less).
Moreover, 86.7% of patients achieved the composite primary effectiveness endpoint at one year, defined by freedom from all-cause mortality, mitral valve reintervention, and MR >2+. The device implantation success rate and procedural success rate reached 97.4%, with 66.7% of patients requiring only a single clip. By 30 days following the procedure, 100% of patients had improved to New York Heart Association (NYHA) Class I or II, a status that was sustained through the one-year follow-up period.
Currently, DragonFly™ has received regulatory approvals in 15 countries and regions, with its clinical use and commercial adoption already in progress in key international markets, including Latin America and Southeast Asia. Valgen Medtech continues to focus on innovation driven by clinical needs, aiming to broaden access to safe, effective, and minimally invasive treatment options for patients worldwide.