Peijia Medical-B Secures NMPA Approval for GeminiOne® Transcatheter Edge-to-Edge Repair System

Stock News

Sep 11

PEIJIA-B (09996) has announced that its independently developed GeminiOne® transcatheter edge-to-edge repair (TEER) system has recently received approval for registration from the National Medical Products Administration (NMPA) of the People's Republic of China.

The approval of GeminiOne® marks the group's formal entry into the commercial treatment field for mitral regurgitation, and represents a significant expansion of its transcatheter valve therapy product portfolio, building on its existing presence in aortic stenosis and aortic regurgitation treatments.

Regarding the EU MDR CE marking registration application and US early feasibility study for GeminiOne®, the EU MDR CE marking registration application has been submitted, while the US early feasibility study is currently underway.

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