#Germany #Frankfurt #Dragonfly #Mitral Valve #Valgen Medtech

Valgen Medtech's Groundbreaking Approval

Valgen Medtech has taken a significant step in the medical field with its DragonFly™ Transcatheter Mitral Valve Repair System receiving CE mark approval from the European Union for the treatment of Functional Mitral Regurgitation (FMR). This follows the earlier approval for Degenerative Mitral Regurgitation (DMR) granted in April 2025. With this dual endorsement, the DragonFly™ System becomes the first device of its kind developed in China to achieve such recognition in the EU for both indications.

The Importance of the DragonFly™ System

Mitral regurgitation is one of the most common heart valve disorders, and FMR often arises in patients suffering from heart failure, presenting clinical challenges. Recently, guidelines have shifted to encourage advanced treatment methods. In 2025, the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) updated their treatment protocols, endorsing transcatheter edge-to-edge repair (TEER) for appropriate patients, elevating it to a Class I recommendation - signifying strong support for this intervention.

Positive Clinical Insights

The background supporting the DragonFly™ System encompasses extensive clinical evidence collected through various multicenter studies across Asia, Europe, and beyond. These studies include pivotal trials like DragonFly-DMR, DragonFly-FMR, and DragonFly-EU. Notably, the findings from the one-year follow-up of the DragonFly-DMR EU Pivotal Study demonstrated promising results. Among the key points:

• - 100% of patients managed to keep their mitral regurgitation severity at ≤2+ (moderate or less).
• - An impressive 86.7% of patients achieved the primary effectiveness endpoint, which encompassed freedom from all-cause mortality, mitral valve reintervention, and MR >2+.
• - The procedural success rate reached an outstanding 97.4%, with the majority of patients needing only a single clip.

Enhanced Functional Outcomes

Moreover, improvements in functional status were evident. Within just 30 days post-procedure, all participating patients had transitioned to New York Heart Association (NYHA) Class I or II, maintaining this improvement through the one-year follow-up. Evidence also suggests that patients experienced beneficial cardiac reverse remodeling, a crucial factor in heart health recovery.

Broadening Impact and Future Commitment

Currently, the DragonFly™ System is already in routine clinical use and has gained regulatory approvals in 15 countries and regions, including prominent markets in Latin America and Southeast Asia. Valgen Medtech’s commitment to innovation remains focused on addressing clinical needs while expanding access to safe and effective minimally invasive treatment options for patients across the globe. The ongoing usage and acceptance of DragonFly™ solidify its place as a promising treatment option in the management of mitral valve conditions, signifying hope for millions affected by heart diseases.

In conclusion, as international clinical standards evolve and feedback from various societies back the DragonFly™ System, Valgen Medtech demonstrates its leading role in advancing cardiac care, promising enhanced treatment pathways for those in need.