#Germany #Frankfurt #Mitral Regurgitation #Valgen Medtech #DragonFly™

Valgen Medtech's DragonFly™ System Achieves EU Approval for FMR

Introduction

In a significant advancement for cardiac treatment, Valgen Medtech has announced that its proprietary DragonFly™ Transcatheter Mitral Valve Repair System has successfully received CE marking from the European Union (EU) for the treatment of Functional Mitral Regurgitation (FMR). This achievement follows the earlier approval for degenerative mitral regurgitation treatment, making DragonFly™ the first Chinese-designed transcatheter valve repair system to gain such recognition in Europe.

Background on Mitral Regurgitation

Mitral regurgitation is among the most prevalent valve diseases globally, significantly impacting patients suffering from heart failure. FMR presents unique challenges in clinical management, and recent updates to international guidelines underscore the necessity for effective treatment strategies. The European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) have recently upgraded their recommendations concerning transcatheter edge-to-edge repair (TEER) techniques for patients with ventricular FMR to a Class I recommendation – the highest level of endorsement.

Recommended Treatment Approaches

In April 2026, the Asia-Pacific Society of Cardiology (APSC) published a consensus statement in the JACC Asia journal, outlining a standardized care pathway for symptomatic patients with moderate to severe FMR who are candidates for TEER treatment. This framework addresses long-term management and aims to improve patient outcomes through specialized care protocols.

Clinical Data Supporting DragonFly™

The DragonFly™ system is backed by extensive clinical data sourced from multiple studies conducted across Asia, Europe, and other regions, including pivotal DragonFly-DMR and DragonFly-FMR trials. Preliminary one-year follow-up results from the European pivotal study presented at the 2026 CSI Frankfurt conference indicate that the device demonstrated significant safety, durability, and clinical performance in high-risk elderly patients with severe degenerative mitral regurgitation.

Key Findings:

• - Sustained MR Reduction: At one-year follow-up, all patients maintained a mitral regurgitation score of ≤2+ (moderate or less).
• - Primary Efficacy Endpoint: A composite primary efficacy endpoint, defined as the absence of all-cause mortality, re-intervention on the mitral valve, and MR > 2+, was achieved in 86.7% of patients.
• - High Implant and Intervention Success Rates: The system demonstrated a remarkable 97.4% success rate for both device implantation and intervention; 66.7% of patients required only one clip.
• - Improvement in Functional State: By 30 days post-intervention, all patients reported functional improvement, categorizing themselves as NYHA Class I or II and maintaining these results throughout the one-year follow-up, alongside favorable cardiac remodeling outcomes.

Global Regulatory Approvals and Market Initiatives

To date, the DragonFly™ system has secured regulatory approvals in 15 countries, with clinical use initiated in key international markets, including regions in Latin America and Southeast Asia. Valgen Medtech remains committed to innovating based on clinical needs, striving to extend safe and effective therapeutic options worldwide for patients suffering from mitral valve disorders.

Conclusion

The approval of the DragonFly™ system is a remarkable milestone in the treatment landscape for functional mitral regurgitation, offering hope and improved outcomes for patients globally. Valgen Medtech's dedication to advancing cardiac technologies highlights the ongoing evolution of medical interventions aimed at providing safer, minimally invasive solutions that align with the rising demands of modern healthcare.