This latest regulatory clearance follows the device's initial EU approval for degenerative mitral regurgitation granted in April 2025. The expansion aligns with evolving global standards, specifically the 2025 update from the European Society of Cardiology and the European Association for Cardio-Thoracic Surgery, which elevated transcatheter edge-to-edge repair to a Class I recommendation for specific patients with ventricular functional mitral regurgitation.
Valgen Medtech’s DragonFly System Cleared for FMR Treatment in Europe
With the CE mark approval for functional mitral regurgitation, Valgen Medtech’s DragonFly system becomes the first Chinese-developed transcatheter device to secure dual indications for both degenerative and functional mitral valve repair in the European Union, marking a significant expansion of the company's international clinical footprint.
Clinical data supporting the system continues to grow, bolstered by results from the DragonFly-DMR EU pivotal trial presented at CSI Frankfurt 2026. Data from the study show that 100% of participants maintained mitral regurgitation severity at or below 2+ one year after the procedure. Furthermore, 86.7% of patients met the composite primary effectiveness endpoint, while procedural success rates reached 97.4%. Valgen Medtech currently holds regulatory approvals in 15 countries and regions, with the DragonFly system already seeing routine clinical implementation across markets in Southeast Asia and Latin America.
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