China's Peijia Targets Europe's Heart Valve Market with GeminiOne

HONG KONG – February 09, 2026 – Chinese medical device innovator Peijia Medical has officially submitted its GeminiOne® Transcatheter Edge-to-Edge Repair (TEER) System for CE Mark registration, a decisive move to enter the highly competitive European market for structural heart disease treatment. The application, filed under the European Union's stringent Medical Device Regulation (EU MDR), signals the company's ambition to challenge Western dominance in the lucrative field of mitral regurgitation therapy.

The submission represents a cornerstone of Peijia's global expansion strategy, which now sees the company simultaneously navigating regulatory pathways in Europe, the United States, and its home market of China. Success in Europe would not only open a significant new revenue stream but also validate its technology on a world stage.

A New Contender in a High-Stakes Market

Mitral regurgitation (MR), a condition where the heart's mitral valve doesn't close properly, is the most prevalent form of valvular heart disease in Europe. For many patients deemed too high-risk for open-heart surgery, minimally invasive TEER procedures have become a life-changing standard of care. This market, however, has long been a duopoly dominated by two major players: Abbott's MitraClip system, the pioneering device in the space, and Edwards Lifesciences' PASCAL system.

These established systems have set a high bar for clinical efficacy and market penetration. Yet, a persistent unmet need remains for devices that can address more complex valve anatomies and simplify the technically demanding procedure. Peijia Medical aims to carve out its niche by positioning the GeminiOne system as a next-generation device designed to overcome some of these existing limitations.

The GeminiOne Advantage: Innovating Heart Repair

At the heart of Peijia's strategy is the unique design of the GeminiOne system. The company highlights several key features intended to provide physicians with greater control and adaptability. A novel sliding groove mechanism is engineered to achieve a longer coaptation length—the surface area where the valve leaflets meet—while keeping the implant and its delivery catheter compact. This could potentially allow for effective treatment in a wider range of patients.

Furthermore, the system incorporates an independent leaflet grasping feature, similar to the PASCAL device, which is intended to reduce procedural complexity. An auto-locking mechanism aims to improve efficiency by preventing the need for repeated locking and unlocking actions during the delicate implant positioning process. Finally, its multi-angular detachment capability is designed to offer more flexibility in accommodating unique patient anatomies.

These technological advancements, protected by global patents and cleared through multiple freedom-to-operate analyses, represent Peijia's bid to offer a more versatile and user-friendly tool for interventional cardiologists.

Navigating the EU's Regulatory Gauntlet

Peijia's entry into Europe is contingent on clearing the EU MDR, a regulatory framework that came into full effect in 2021. The MDR replaced the previous Medical Device Directive with a far more demanding set of rules emphasizing lifecycle safety, robust clinical evidence, and stringent post-market surveillance. For a Class III cardiovascular device like GeminiOne, the path to approval is notoriously complex and costly, often requiring hundreds of thousands of euros and extensive clinical data.

For a non-EU company, the challenge is even greater. The submission itself, made in partnership with European partner HighLife SAS, is a testament to Peijia's confidence in its technical documentation and clinical data. HighLife SAS, a French company specializing in its own trans-septal mitral valve replacement (TSMVR) technology, brings crucial regional expertise. This partnership builds on a pre-existing relationship from 2020, where Peijia secured rights to manufacture and commercialize HighLife's technology in China, demonstrating a history of successful cross-continental collaboration.

A Coordinated Global Strategy

The European submission is just one front in Peijia's multi-pronged global offensive. The registration application for GeminiOne has already been accepted and is under review by China's National Medical Products Administration (NMPA). Simultaneously, the company has secured Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to conduct an Early Feasibility Study in the United States. This coordinated, three-continent approach underscores a level of strategic ambition rarely seen from Chinese medtech firms.

This global push is backed by solid financial performance and a deep commitment to research and development. The Suzhou-based company reported revenues of approximately RMB 700-720 million for 2025, a significant increase driven by its neurointerventional and transcatheter aortic valve replacement (TAVR) businesses. Notably, its TAVR division achieved commercial profitability for the first time in 2025, signaling a maturing business model capable of funding its ambitious pipeline.

With a portfolio that already includes multiple approved TAVR systems and nearly twenty neurointerventional devices in China, Peijia Medical is not a startup testing the waters. It is an established regional powerhouse leveraging its domestic success to fuel a bid for global leadership. The journey through the EU MDR will be a critical test, but one the company appears well-equipped to undertake. The successful navigation of these parallel regulatory pathways will be the ultimate trial of Peijia's ambition to transform from a regional leader into a global force in the treatment of structural heart disease.