European approval covers the treatment of functional mitral regurgitation (FMR). It follows CE mark for degenerative mitral regurgitation (DMR) in April 2025.
Hangzhou, China-based Valgen says the latest authorization positions DragonFly as the first transcatheter mitral valve repair device originating in China to receive European approval for both DMR and FMR indications.
DragonFly offers transfemoral transcatheter edge-to-edge mitral valve repair. It features controllable clipping for safety with a central filler for reducing central residual regurgitation. The system works across a range of anatomies, with four clip sizes and independent grasping. Readable indicators and rotary knobs increase operating accuracy and intuition, with a three-stage separative catheter design delivering accurate positioning.
Other similar devices out there for mitral repair include the Abbott MitraClip and Edwards’ Pascal system.
DragonFly brings an extensive body of clinical evidence, including sustained MR reduction at one year and 86.7% composite primary effectiveness, defined as freedom from all-cause mortality, mitral valve reintervention, and MR >2+. The company also reports high procedural success rates.
To date, the system holds regulatory approvals across 15 countries and regions. Valgen already has adoption underway in key markets such as Latin America and Southeast Asia.
