Medpark Company XinQing Medical Receives NMPA Approval for China's First Extracorporeal Fully Magnetically Levitated Artificial Heart

Today, the National Medical Products Administration (NMPA) of China approved the product registration application for "MoyoAssist® Extracorporeal Ventricular Assist System" developed and manufactured by Medpark-based magAssist. The registration certificate numbers are "GuoXieZhuZhun 20243100773" for the extracorporeal ventricular assist device and "GuoXieZhuZhun 20243100774" for the extracorporeal ventricular assist pump head and tubing.

It is worth mentioning that MoyoAssist® is the first extracorporeal ventricular assist device and dedicated consumables in China to feature full magnetic levitation technology. This approval for marketing represents another breakthrough for high-end medical devices produced in China.

For critically ill patients

Building the Last Line of Defense for Life

MoyoAssist® is a fully magnetically levitated centrifugal pump that provides medium- to short-term extracorporeal ventricular assistance, designed for critical conditions requiring temporary cardiac pumping support, such as heart failure and cardiogenic shock. Utilizing globally advanced computational fluid dynamics technology and full magnetic levitation, the product ensures blood compatibility and can offer support for up to 30 days. It supports multiple modes, including post-cardiac surgery extracorporeal circulation when weaning is not possible, bridging to cardiac function recovery, and transitioning to other long-term alternative treatments.

The clinical trial of MoyoAssist® was led by Professor Nian-Guo Dong, the Principal Investigator (PI), who serves as the Director of the Department of Cardiac and Great Vessel Surgery and the Director of the Organ Transplant Center at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Multiple clinical centers across China participated in the trial. The entire clinical trial was successfully completed early last year and received approval as an "Innovative Medical Device" from the National Medical Products Administration (NMPA). Professor Nian-Guo Dong commented: “The external fully magnetically levitated artificial heart causes minimal trauma, allows for rapid recovery, and is reasonably priced. It can serve as an excellent bridge to heart transplantation, enabling patients who temporarily cannot find a matching donor heart to wait longer and have access to treatment.” Professor Nian-Guo Dong pointed out that this external fully magnetically levitated artificial heart, as a ventricular assist device, holds significant importance for heart failure patients or those awaiting heart transplantation.

Focus on the field of life support

Promote the Localization of High-End Medical Devices in China

Since its establishment in May 2017, magAssist has been committed to implementing China's strategy for the domestic production of high-end medical devices. It has been focusing on key technological breakthroughs in the field of life support, continuously developing and implementing new solutions. After years of arduous exploration, magAssist has independently innovated and developed the MoyoAssist® External Ventricular Assist System, which demonstrates excellent hemocompatibility and ease of management, with the hope of benefiting more patients.

In order to achieve a "zero" breakthrough in domestically produced products, magAssist has invested hundreds of millions in research and development funds since its establishment. Dr. Xu Bolei, the founder, collaborated with numerous top R&D talents from within and outside China to build a complete life support equipment R&D and manufacturing team. The first product, MoyoAssist® entire system, was fully self-developed and self-produced. Encouraged by the national policy of "replacement of high-end medical devices with domestically produced alternatives," it will quickly penetrate the domestic market while also having the advantage for overseas expansion.

magAssist Provides Closed-loop Solutions for Critical Care Treatment on Life Support Platforms

At the same time, magAssist, starting from heart failure, is committed to building a multi-organ life support platform. Based on the MoyoAssist® fully magnetically levitated centrifugal pump technology platform, it has developed the latest generation of Extracorporeal Membrane Oxygenation (ECMO) system. Using the same control platform, it has also created the world’s smallest minimally invasive interventional artificial heart, which has become the only artificial heart product to receive "dual innovation" designations in both China and the United States.

magAssist's existing three product lines are all products that fill domestic gaps in China or have been long monopolized by imports. Currently, magAssist has achieved full coverage of non-endpoint treatments for heart failure, the widest range of indications, and multi-scenario, multi-age group support. In the future, under a platform-based product layout, the company aims to expand into life support devices for more organs, realizing the vision of a multi-organ life support platform. To date, magAssist has submitted over 300 patent applications, initially establishing a strong competitive edge in the independent research and development of high-end life support equipment.

In the future, with the continuous promotion of the "prioritizing domestically produced" national policy, it is believed that there will be an increasing number of independent innovation technologies emerging in the medical device field. The rise of "localization" is now unstoppable. The approval and market launch of MoyoAssist® marks the starting point of magAssist's commercialization. magAssist will continue to focus on the life support field, developing more truly excellent products to serve patients in China and even around the world.