XinQing Medical Receives NMPA Approval for Two Innovative Devices: China’s First Extracorporeal Fully Magnetically Levitated Artificial Heart

On April 28, the National Medical Products Administration announced the approval of two innovative product registration applications from magAssist (Suzhou) Co., Ltd. ("magAssist"): the "External Ventricular Assist Device" and the "External Ventricular Assist Pump Head and Tubing." It is reported that this product is China's first external full magnetic levitation artificial heart.

Image Source: NMPA Official Website

According to the NMPA official website, the extracorporeal ventricular assist device consists of a magnetic levitation motor, control host, and accessories. The extracorporeal ventricular assist pump head and tubing include a centrifugal pump head, side-hole straight connector, Luer cap, tube clamp, and zip tie. The two products are used together, connected to blood vessels to form a bypass circuit. Through the control host and magnetic levitation motor, the impeller inside the pump head is driven to rotate in a suspended state, providing kinetic energy to increase blood pressure. It is used for temporary extracorporeal mechanical circulatory support in post-cardiac surgery patients.

This product adopts full magnetic suspension blood pump technology, featuring anti-vibration and anti-torsion performance as well as an optimized blood flow field design, which can effectively reduce the average incidence of blood compatibility-related complications.

magAssist stated that the entire system of this product (MoyoAssist®) is independently developed and produced. Encouraged by the national policy of "replacement of high-end medical devices with domestically produced alternatives," it will quickly penetrate the Chinese market while also holding an advantage for overseas expansion.

About magAssist

magAssist is dedicated to building a next-generation extracorporeal life support platform for critical care scenarios. It has developed multiple promising artificial organ product pipelines, with main products including: minimally invasive interventional artificial heart, extracorporeal fully magnetically levitated artificial heart, a new generation of portable extracorporeal membrane oxygenation system (ECMO), and a warm blood organ transport platform, among others.

Image Source: magAssist

Among them, the extracorporeal fully magnetically levitated artificial heart utilizes globally advanced computational fluid dynamics technology and fully magnetic levitation technology to ensure blood compatibility. It can provide support for up to 30 days, stably supporting transitions to recovery (BTR), transplantation (BTT), or other treatment methods (BTD) within the possible time frame, ensuring surgical safety while minimizing patient trauma. According to publicly available information, the extracorporeal fully magnetically levitated artificial heart has also won multiple domestic and international design awards, including the Australian Designer Award, the Australian Good Design Award, Fortune China's Best Design Award, and the German iF Design Award, known as the "Oscar" of the design world.

Image Source: magAssist

Minimally Invasive Interventional Artificial Heart is another key product of magAssist. It has successively received the FDA "Breakthrough Device" designation and the National Medical Products Administration's innovative medical device approval, simultaneously achieving "dual innovation recognition in both China and the U.S." Heart failure is recognized as the end-stage of heart disease development, with a five-year mortality rate as high as 30-70%, and is widely regarded as "the final battlefield in the field of cardiovascular diseases." The minimally invasive interventional artificial heart can replace the function of a failing heart, providing circulatory support for critically ill cardiovascular patients such as those with complex coronary artery disease, acute myocardial infarction complicated by cardiogenic shock, or acute decompensation of chronic heart failure.

magAssist Develops New Generation Portable Extracorporeal Membrane Oxygenation System (ECMO), Commonly Known as "Artificial Lung," Mainly Used to Maintain the Respiratory and Circulatory Functions of Patients with Severe Heart and Lung Failure, Prolonging Life and Buying Precious Time for the Rescue of Critically Ill Patients. This product is developed based on third-generation active magnetic levitation drive technology, using computational fluid dynamics design and optimization technology, and mechatronics technology for magnetic levitation and drive systems, completely eliminating mechanical friction, improving blood compatibility, and significantly enhancing the performance and safety of ECMO. The optimized flow channel design extends the usage time of the oxygenator to twice that of currently imported equipment in China. The membrane fiber configuration optimization technology greatly improves oxygen exchange efficiency, reduces flow resistance, making the artificial lung closer to a natural lung. Additionally, its ultra-portable design meets the demands of more complex clinical scenarios.

Image Source: magAssist

In addition, magAssist has several products under development, including a warm-blood organ transport platform. magAssist stated that in the future, it aims to meet clinical needs across acute and critical care extracorporeal life support scenarios, continuously expanding its product portfolio. The company is developing acute and critical care extracorporeal life support platforms tailored to different populations, varying support requirements, and diverse clinical scenarios, serving patients in China and around the world.

Editor: Penicillin

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