Valgen Medtech has received CE mark approval for its DragonFly transcatheter mitral valve repair system for the treatment of functional mitral regurgitation (FMR), expanding on the device’s approval for degenerative mitral regurgitation (DMR) granted in April 2025.
The milestone makes DragonFly the first China-developed transcatheter mitral valve repair system to receive European approval for both DMR and FMR indications.
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DragonFly is a transfemoral transcatheter edge-to-edge repair (TEER) device designed to treat mitral valve leakage across a wide range of patient anatomies. The system includes independent grasping, multiple clip sizes, and positioning features intended to improve procedural accuracy and outcomes.
Valgen said clinical data have demonstrated sustained mitral regurgitation reduction at one year, an 86.7% composite effectiveness rate, and high procedural success.
The company stated that the approval:
“Positions DragonFly as the first transcatheter mitral valve repair device originating in China to receive European approval for both DMR and FMR indications.”
With approvals now covering both major mitral regurgitation indications, Valgen is strengthening DragonFly’s position in the global structural heart market, where it competes with established transcatheter repair technologies.
