Peijia Medical (Suzhou, China) announced today that it has submitted to receive a CE mark for its GeminiOne transcatheter edge-to-edge repair (TEER) system to treat mitral regurgitation.
Paris-based HighLife, which recently secured a CE mark for its transcatheter mitral valve replacement (TMVR) system, is Peijia Medical’s European partner in the submission.
According to Peijia Medical, GeminiOne features a unique sliding-groove mechanism that enables longer coaptation while maintaining a smaller implant size and delivery system. It also has an independent leaflet grasping design intended to reduce procedural complexity, an auto-locking mechanism to prevent repeated locking and unlocking during the procedure, and a multi-angular detachment capability for a wider range of anatomical variations.
In addition to seeking a CE mark, Peijia Medical has GeminiOne under review by the National Medical Products Administration (NMPA) in China. In the U.S., the FDA has granted an Investigational Device Exemption (IDE) to enable an early feasibility study.
The Chinese company presently has four TAVR systems and nearly 20 neurointerventional devices registered in China. GeminiOne represents a bid to compete in a TEER space currently dominated by companies such as Abbott and Edwards Lifesciences.
