Valgen Medtech's DragonFly™ System Gains EU Approval for FMR Treatment

Overview of the DragonFly™ System

Valgen Medtech recently revealed that its proprietary DragonFly™ Transcatheter Mitral Valve Repair System has secured CE mark approval in the European Union for the treatment of functional mitral regurgitation (FMR). This certification marks a significant milestone for the DragonFly™ system, adding to its previous approval for degenerative mitral regurgitation (DMR) in April 2025, making it the first transcatheter valve repair system from China to earn such approvals for both indications in the EU.

In an evolving landscape of international clinical guidelines and consensus recommendations, mitral regurgitation (MR) is recognized as one of the most prevalent heart valve diseases globally, with FMR being particularly complex as it often arises in patients with heart failure. Recent years have seen a growing consensus on optimal treatment strategies for this challenging condition.

Classification and Recommendations

The European Society of Cardiology (ESC) and the European Association of Cardio-Thoracic Surgery (EACTS) updated their guidelines in 2025, promoting transcatheter edge-to-edge repair (TEER) for selected patients with ventricular functional mitral regurgitation (vFMR) to a Class I recommendation, indicating the highest level of endorsement.

Further, the Asia Pacific Society of Cardiology (APSC) published a consensus statement in JACC Asia in April 2026 outlining a standardized treatment pathway for symptomatic patients suffering from moderate to severe or advanced FMR who are candidates for TEER therapy.

Clinical Evidence Supporting DragonFly™

The DragonFly™ system is underpinned by extensive clinical evidence gathered from various multicentric studies across Asia, Europe, and other regions. Notable studies include DragonFly-DMR, DragonFly-FMR, and DragonFly-EU, which provided essential data to support the recent EU approval. At the CSI Frankfurt 2026, Valgen Medtech presented the findings of the one-year follow-up phase from the EU approval study for DragonFly-DMR, which demonstrated a favorable safety profile and effective clinical outcomes among older patients at high surgical risk with severe DMR.

Key Findings

The one-year follow-up of the study revealed that 100% of patients maintained a mitral regurgitation severity of ≤2+ (moderate or less). Moreover, the primary efficacy endpoint—comprising freedom from all-cause mortality, mitral valve re-intervention, and MR >2+—was achieved by 86.7% of patients.

The device implantation success rate stood at an impressive 97.4%, and notably, 66.7% of patients required only a single clip for their procedure. Additionally, 30 days post-procedure, all patients had improved to New York Heart Association (NYHA) Class I or II, sustaining this improvement throughout the one-year follow-up, alongside favorable cardiac reverse remodeling.

Global Impact and Future Prospects

Thus far, the DragonFly™ system has gained regulatory approvals in 15 countries and regions, with routine clinical use and commercial launches already underway in key international markets including Latin America and Southeast Asia. Valgen Medtech remains committed to innovation that responds to clinical needs, expanding access to safe, effective, and minimally invasive treatment alternatives for patients worldwide. With the recent EU approval, the DragonFly™ system is poised to play a transformative role in the management of mitral valve diseases, offering hope and improved outcomes for patients facing these serious health challenges.