NMPA grants approval to MoyoAssist® China's first full maglev extracorporeal VAD

The National Medical Products Administration (NMPA) of China has granted approval to Extracorporeal Ventricular Assist System - MoyoAssist®, developed by magAssist CO., Ltd. (magAssist) in April 2024.

It makes magAssist the first[1] approved full maglev extracorporeal ventricular assist device (ExtraVAD) and dedicated consumables in China and this approval for market entry represents another significant breakthrough in the field of high-end domestic medical devices.

Forging a Lifesaving Fortress for Critical Patients

MoyoAssist® is a full maglev centrifugal pump that provides short-term to medium extracorporeal ventricular assistance. It is used in critical conditions such as heart failure and cardiogenic shock where temporary mechanical circulatory support is required. This product incorporates advanced global computational fluid dynamics technology and full magnetic levitation technology, ensuring blood hemocompatibility. It can provide support for up to 30 days and offers multiple modes, including patients who are unable to be weaned off cardiopulmonary bypass after cardiac surgery, transitioning to cardiac recovery, or transitioning to other long-term alternative therapies.

The clinical trials of MoyoAssist® were led by Professor Dong Nian-guo, Director of Cardiovascular Surgery department and Organ Transplantation Center in Union Hospital of Tongji Medical College Huazhong University of Science and Technology. The trials were successfully completed early last year, and the device obtained the approval of the NMPA as an "Innovative Medical Device". Professor Dong Nian-guo commented, "The full maglev ExtraVAD has the advantages of less invasiveness, rapid recovery, and reasonable price. It serves as an excellent bridge for heart transplantation, making it accessible and beneficial for patients who are temporarily unable to receive a donor heart."  Professor Dong Nian-guo further emphasized the critical significance of the fully maglev ExtraVAD as an auxiliary circulatory support device, holding immense value for patients suffering from heart failure or those awaiting heart transplantation.

Empowering Life Support
Advancing Domestic Production of high-end Medical Devices.

Since its establishment in May 2017, magAssist has remained steadfast in its pursuit of critical technological innovation in the field of life support, continuously driving research and implementation. 

Beginning with a focus on heart failure, magAssist is dedicated to constructing a comprehensive multi-organ life support platform. Based on the same platform, the company has developed the new generation of extracorporeal membrane oxygenation (ECMO) system, as well as pVAD, becoming the only[1] Chinese medical company receiving designation of innovative medical device in both China and the United States in the field of mechanical circulation support.

magAssist is proud to announce the NMPA approval of MoyoAssist®, a significant milestone that marks the beginning of commercialization for the company. magAssist will continue to explore within the realm of life support and to serve patients not only in China but also worldwide.

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[1] 国家药品监督管理局. 体外心室辅助设备和体外心室辅助泵头及管路获批上市[EB/OL]. [2024.4.28].