Domestic Cardiac Device Breakthrough: Shenqi Medical's SQ-Kyrin-M® Approved, Offering Minimally Invasive Option for High-Risk Mitral Regurgitation Patients

The heart, as the "power pump" of the human body, carries the hope of life with every beat. However, when the heart valves start to "leak," the rhythm of life is disrupted — this is mitral regurgitation, a type of structural heart disease that commonly occurs in middle-aged and elderly populations. In severe cases, it can lead to heart failure and even endanger life.

Just recently,重磅 good news came from the field of structural heart disease treatment in China:Shanghai Shenqi Medical Technology Co., Ltd.'s self-developed Qi Lin-M® (SQ-Kyrin-M®) Transcatheter Mitral Valve Clip System has officially received approval from the National Medical Products Administration (NMPA) for market release.(China Medical Device Registration No. 20263130777), offering a new minimally invasive treatment option for many high-risk patients and showcasing the innovative strength of China's high-end medical equipment.

Here is a simple interpretation for everyone: The mitral valve is the "valve" between the left atrium and left ventricle of the heart. Under normal circumstances, blood can only flow from the atrium to the ventricle; mitral valve regurgitation occurs when this "valve" does not close properly, causing blood to flow backward and increasing the burden on the heart. Among these cases, degenerative mitral regurgitation (MR≥3+) is considered moderate to severe regurgitation. Patients often experience shortness of breath after activity, nocturnal breathing difficulties, and lower limb edema. If left untreated for a long time, it can severely impair cardiac function.

For these patients, traditional treatment methods mainly involve surgical repair or valve replacement. However, many patients, due to their older age and the presence of multiple underlying diseases, are assessed as high-risk for surgery and cannot tolerate the trauma of open-chest surgery, leaving them in a dilemma of "wanting treatment but being unable to receive it."

The approval of QiLin-M® has precisely addressed this clinical pain point. This transcatheter mitral valve clip system employs a percutaneous minimally invasive approach, eliminating the need for open-heart surgery. The device can be delivered to the heart valve area through the blood vessels, enabling precise treatment.

In terms of product design, QiLin-M® is composed of a mitral valve clip and delivery system, as well as a guidance system, with its core advantages lying inThe valve leaflets can be independently captured, and the delivery system can be multi-directionally bent.，It can more flexibly adapt to the valve anatomy of different patients, improving the success rate and safety of the surgery. The applicable population is clearly defined: patients with degenerative mitral regurgitation (MR≥3+) who are assessed by a heart team (including cardiac surgeons, cardiologists, and echocardiography specialists) as having a high risk for surgical procedures and suitable mitral valve anatomy. It is especially suited for elderly and middle-aged high-risk groups who cannot tolerate open-chest surgery.

It is worth mentioning that this product, which carries the innovative strength of Chinese production, was not achieved overnight. Its research and development process has undergone many years of deep cultivation, with each step being solid and rigorous. The complete R&D history is as follows:

On September 9, 2014, Shanghai Shenqi Medical Technology Co., Ltd. was officially established in the Zhangjiang Medical Device Industry Base. Dai Zhihao, with 20 years of experience in the cardiovascular field, became the chairman. At its inception, the company established the core concept of "Innovation · Heart Protection," focusing on areas such as vascular intervention, structural heart disease, and heart failure management. It precisely targeted the market gap where high-end cardiac interventional devices were monopolized by foreign countries, initiating early-stage R&D preparations for the transcatheter mitral valve clip system. A professional R&D team composed of experienced medical technical personnel was formed, embarking on a technological path to replace imported products with domestically produced ones. Despite facing initial financial pressures, the company gradually gained policy support and resource security by relying on the innovative ecosystem of the Zhangjiang medical device industry, laying a foundation for its R&D efforts.

From 2018 to 2020, the research and development entered a critical phase. The team focused on overcoming core technical challenges such as leaflet capture and delivery system bending adjustments. By drawing on international advanced experiences and considering the anatomical characteristics of Chinese patients' valves, they optimized product design and completed the prototype development of the transcatheter mitral valve clip system. At the same time, early technical verification was carried out, repeatedly testing product performance and gradually addressing key issues like device compatibility and operational flexibility, paving the way for subsequent technical finalization. This phase was also a crucial period for Shenqi Medical to overcome the "five years of zero revenue" hardship and adhere to its original commitment to research and development.

From August to September 2021, the research and development achieved a decisive key breakthrough. The core technology of the QiLin-M® (SQ-Kyrin-M®) Transcatheter Mitral Valve Clip System was finalized. Its innovative features, such as the multi-layer adjustable bending delivery sheath design and independent leaflet capture, are on par with the latest generation of similar international products. With its outstanding innovative advantages and clear clinical value, it successfully passed the "Special Review Procedure for Innovative Medical Devices" and entered the National Medical Products Administration’s "Green Channel" for innovative products, significantly accelerating subsequent marketing approval. This is also an important milestone in the product development process, marking the formal entry of the product into the standardized approval track.

In 2022, the product entered the preclinical critical validation phase. Relying on the resource support from the Zhangjiang Public Technology Service Platform, it completed full-performance bench testing and simultaneously conducted standardized large-animal research to focus on verifying the product's safety, efficacy, and compatibility in vivo. Based on the experimental results, the multi-directional bending function of the delivery system was further optimized to ensure precise operation of the device in complex cardiac environments, laying a solid foundation for subsequent clinical trials. In the same year, valve technologies related to Shenqi Medical were preliminarily applied in clinical research, accumulating valuable experience for the clinical implementation of QiLin-M®.

From 2023 to 2025, the product entered the comprehensive verification and clinical trial phase. Shenqi Medical successively initiated multi-center registration clinical trials, collaborating with several top cardiovascular hospitals in China to recruit high-risk patients with degenerative mitral regurgitation (MR≥3+) who met the criteria, comprehensively verifying the safety and effectiveness of the product in clinical scenarios. During this period, based on clinical feedback, the company continuously optimized product details, further refining core functions such as independent leaflet capture and multi-directional bending adjustment of the delivery system. Meanwhile, relying on its solid R&D capabilities, the company was recognized as a national high-tech enterprise. In 2025, it was further awarded the title of a national specialized, refined, distinctive, and innovative "little giant" enterprise, providing stronger support for R&D work. Leveraging the cluster advantages of Zhangjiang's medical device industry and the convenience of the Yangtze River Delta Medical Device Technology Review and Inspection Sub-center, the company steadily advanced the R&D and approval process.

In January 2026, QiLin-M® completed the final round of pre-market review material verification. With comprehensive clinical trial data and outstanding product advantages, it successfully passed the final evaluation by the National Medical Products Administration (NMPA). On April 22, 2026, QiLin-M® officially received approval from the NMPA for market release (Registration Certificate No. 20263130777), marking the official launch of this domestically developed transcatheter mitral valve clip system. From conceptual development to becoming a clinically available medical product, it achieved a complete breakthrough across the entire process from technical challenges to product commercialization. This also fulfilled Shenqi Medical's original mission of "Innovation · Protecting Hearts," making it the eighth innovative medical device approved in Zhangjiang Pharma Valley in 2026.

For the field of structural heart disease treatment, the successful approval of QiLin-M® marks an important milestone for Shenqi Medical and yet another significant achievement in the breakthrough of domestically produced high-end medical devices. For a long time, the area of high-end cardiac interventional devices has been monopolized by foreign brands. The launch of QiLin-M® not only fills the gap for China-produced transcatheter mitral valve clip systems in related fields but also breaks the monopoly of foreign technologies. This allows more Chinese patients to benefit from high-quality medical equipment that is "Made in China," reducing treatment costs while providing a more convenient and safer treatment experience.

From a clinical value perspective, the transcatheter edge-to-edge repair technology adopted by QiLin-M® is currently the internationally recognized minimally invasive valve repair technology with the most substantial clinical evidence—by mechanically clipping, it accurately grasps the mitral valve leaflets to reduce regurgitation, helping the heart restore normal blood flow without the need to resect or replace the native valve. This approach maximally preserves the heart's original function, allowing patients to recover faster post-surgery with shorter hospital stays.

It is reported that the national drug regulatory authorities will strengthen the post-marketing supervision of this product to further ensure the safety of patients using medical devices. Taking the approval of Qi Lin-M® as an opportunity, Shenqi Medical will continue to focus on the field of interventional treatment for structural heart disease, promote the availability of more innovative medical devices, and protect the heart health of the Chinese people with technological power.

For the vast number of patients, the launch of QiLin-M® is undoubtedly a beacon of light in the darkness—it offers new hope for high-risk patients who were previously deemed unfit for surgical procedures, while also transforming the concept of "minimally invasive heart protection" into an attainable reality.

In the future, with the continuous innovation and upgrading of medical devices produced in China, it is believed that more high-quality products like QiLin-M® will enter clinical use, solving more clinical treatment challenges. This will allow Chinese ingenuity to protect every beating heart and enable more patients to regain health and a new lease on life.

End-of-article福利: Follow me for continuous updates on the clinical application cases of Qi Lin-M® and科普on the prevention and treatment of mitral regurgitation, helping you understand the密码of heart health and stay away from the困扰of valve diseases~