Peijia Medical Takes a Major Step in EU with GeminiOne TEER System Submission

Peijia Medical Submits Application for GeminiOne TEER System

On February 9, 2026, Peijia Medical Limited (Stock Number: 9996) made headlines by announcing its submission for the CE Mark registration application under the European Union Medical Device Regulation (EU MDR) for the GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System. This strategic move demonstrates Peijia Medical's ongoing efforts to expand its footprint in international markets, particularly focusing on innovative solutions for treating mitral regurgitation.

Significance of the CE Mark Submission

The submission of the CE Mark is a significant milestone in Peijia Medical's globalization strategy. It not only reflects the company’s commitment to innovation in the healthcare sector but also positions it to be a critical player in the broader European market. With HighLife SAS acting as Peijia's European partner, the collaboration aims to ensure that the introduction of the GeminiOne system will be smooth and successful in meeting the needs of patients.

Features of the GeminiOne TEER System

The GeminiOne TEER System stands out as a novel medical device, showcasing a unique sliding groove mechanism that extends coaptation lengths while keeping the implant size and delivery system small. This innovative design aims to enhance procedural effectiveness and reduce complexity, thereby improving patient outcomes. Furthermore, the system includes an independent leaflet grasping mechanism which simplifies the procedure, an auto-locking feature to avoid repeated locking and unlocking, and multi-angular detachment capabilities that allow for greater adaptability in diverse anatomical variations.

Peijia Medical has applied for global patents on the design of the GeminiOne TEER System and has also passed multiple Freedom-To-Operate (FTO) analyses, reinforcing the system's reliability and innovation.

Regulatory Approvals in Other Markets

In addition to its European ambitions, the GeminiOne TEER System has made strides in Asia. The National Medical Products Administration (NMPA) of the People's Republic of China has accepted its registration application, which is currently undergoing review. Furthermore, the U.S. Food and Drug Administration (U.S. FDA) has granted Investigational Device Exemption (IDE) approval for conducting an Early Feasibility Study (EFS) in the United States. These milestones further validate Peijia Medical's commitment to bringing effective treatment options for mitral regurgitation to patients around the world.

Looking Ahead

With its eyes set on regulatory registrations in both China and Europe, Peijia Medical is committed to accelerating the introduction of safe and effective solutions for patients battling mitral regurgitation. This ongoing focus on innovation and patient care positions Peijia Medical as a leading player in the high-growth interventional procedural medical device market.

About Peijia Medical

Founded in 2012 and headquartered in Suzhou, China, Peijia Medical has quickly established itself as a visionary in the interventional medical device sector. Focused on comprehensive treatment solutions for structural heart and neurovascular diseases, the company boasts four TAVR systems and nearly twenty neurointerventional devices registered in China, alongside many more innovative products in various development stages. For further information, please visit Peijia Medical.