Valgen Medtech's DragonFly™ System Receives EU Approval for FMR Indication

FRANKFURT, Germany and HANGZHOU, China, June 24, 2026 /PRNewswire/ -- Valgen Medtech recently 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).

Following its EU approval for Degenerative Mitral Regurgitation (DMR) in April 2025, this latest authorization positions the DragonFly™ System as the first transcatheter mitral valve repair device originating in China to receive EU approval for both DMR and FMR indications.

Evolving International Clinical Guidelines and Consensus

Mitral regurgitation (MR) is one of the most prevalent valvular heart diseases worldwide. FMR, which commonly occurs in patients with heart failure, remains a particularly complex condition to manage in clinical practice. In recent years, a growing international consensus has emerged regarding optimal treatment strategies for this condition:

• Class I Recommendation in European Guidelines: In 2025, the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) jointly updated their guidelines, upgrading transcatheter edge-to-edge repair (TEER) for the treatment of selected patients with ventricular Functional Mitral Regurgitation (vFMR) to a Class I recommendation, representing the highest level of endorsement.
• Clear Treatment Pathway Established in Asia-Pacific Consensus: In April 2026, the Asia Pacific Society of Cardiology (APSC) published a consensus statement in JACC: Asia, providing a standardized treatment pathway and long-term management strategy for symptomatic patients with moderate-to-severe or more advanced FMR who are candidates for TEER therapy.

Robust Global Clinical Evidence

The DragonFly™ System is supported by an extensive body of clinical evidence generated through a series of multicenter studies across Asia, Europe, and other international regions, including the DragonFly-DMR, DragonFly-FMR, and DragonFly-EU pivotal trials. One-year follow-up results from the DragonFly–DMR EU Pivotal Study, presented by Valgen Medtech at CSI Frankfurt 2026, demonstrated favorable safety, durability, and clinical performance in elderly patients with severe DMR who were at high surgical risk:

• Sustained MR Reduction: At the one-year follow-up, 100% of patients maintained MR severity at ≤2+ (moderate or less).
• Strong Primary Effectiveness Outcome: The composite primary effectiveness endpoint at one year—defined as freedom from all-cause mortality, mitral valve reintervention, and MR >2+—was achieved in 86.7% of patients.
• High Procedural Success: Both the device implantation success rate and procedural success rate reached 97.4%, while 66.7% of patients required just a single clip.
• Sustained Improvement in functional status: By 30 days post-procedure, 100% of patients had improved to New York Heart Association (NYHA) Class I or II and maintained these outcomes through one year of follow-up. The findings also demonstrated favorable cardiac reverse remodeling.

To date, DragonFly™ has received regulatory approvals in 15 countries and regions, with routine clinical use and commercial adoption already underway in key international markets including Latin America and Southeast Asia. Valgen Medtech remains committed to innovation driven by clinical needs, expanding access to safe, effective, and minimally invasive treatment options for patients worldwide.