Peijia seeks EU CE Mark for GeminiOne TEER amid China and U.S. regulatory progress

Peijia pushes GeminiOne toward EU clearance as structural‑heart rivals watch

Peijia Medical formally submits a European Union Medical Device Regulation (EU MDR) CE Mark application for its GeminiOne Transcatheter Edge‑to‑Edge Repair (TEER) system, seeking to enter the European structural‑heart device market. The company names French partner HighLife SAS to support registration and distribution in Europe, a step Peijia frames as central to its globalization strategy. The filing comes as the device is also under review by China’s National Medical Products Administration (NMPA) and has secured an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration to begin an Early Feasibility Study (EFS) in the United States.

GeminiOne’s design targets procedural simplicity and broader anatomical fit, features that matter in a crowded TEER field where device profile and ease of use influence adoption. The device employs a patented sliding‑groove mechanism intended to increase coaptation length without enlarging implant or delivery size, an independent leaflet‑grasping system to reduce steps during implantation, an auto‑locking feature to prevent intra‑procedural rework, and multi‑angular detachment to accommodate variable mitral anatomy. Peijia reports multiple freedom‑to‑operate analyses clear its intellectual property stance, positioning GeminiOne as a potentially competitive entrant in transcatheter mitral repair.

Regulatory momentum in three jurisdictions is central to Peijia’s commercial pathway: concurrent EU MDR submission, NMPA acceptance in China, and U.S. IDE approval for an early feasibility trial. Success in Europe would provide a major market access point and validation under the more stringent EU MDR framework, potentially smoothing later clinical adoption and reimbursement discussions. The company stresses GeminiOne remains under clinical and regulatory evaluation and is not approved for commercial sale in any country.

Domestic registrations and pipeline progress

Peijia, founded in 2012 and based in Suzhou, continues to expand its domestic footprint, listing four transcatheter aortic valve replacement (TAVR) systems and nearly 20 neurointerventional devices registered in China. The company says it is actively advancing regulatory registrations in China and Europe while developing additional structural‑heart and neurovascular candidates at various stages.

Clinical and regulatory caution

Peijia warns that timelines for product availability and commercialization are forward‑looking and subject to regulatory, clinical and market risks. The firm notes GeminiOne’s U.S. EFS and other regulatory steps are ongoing, underscoring that commercial launch depends on successful trial outcomes and approvals.