Two Innovative Medical Devices by XinQing Medical Receive NMPA Approval for Market Launch

Apr 29, 2024 00:01 CST Updated 00:01

magAssist

Developer of Extracorporeal Artificial Heart Devices

On April 28, 2024, NMPA approved "Extracorporeal Ventricular Assist DeviceAndExternal Ventricular Assist Pump Head and Tubing"Innovative product registration application," the original text is as follows:

"Recently, the National Medical Products Administration approvedmagAssist (Suzhou) Co., Ltd.“Ventricular Assist Device (VAD)" and "External Ventricular Assist Pump Head and Tubing"Registration Application for Innovative Products."

The extracorporeal ventricular assist device consists of a magnetic levitation motor, a control host, and accessories. The extracorporeal ventricular assist pump head and tubing include a centrifugal pump head, side-hole straight connectors, Luer caps, tube clamps, and zip ties. When used together, the two products connect with blood vessels to form a bypass circuit. The control host and magnetic levitation motor drive the impeller inside the pump head to rotate in a suspended state, providing kinetic energy to increase blood pressure for temporary extracorporeal mechanical circulatory support in post-cardiac surgery patients.

▲MoyoAssist®（(Image source: Official)

The ProductAdopting full magnetic levitation blood pump technology, it features anti-vibration and anti-torsion performance as well as an optimized blood flow field design, effectively reducing the average incidence of blood compatibility-related complications.。

The pharmaceutical regulatory authorities will strengthen the post-market supervision of this product to protect the safety of patients using medical devices.

# The First in China!

Full Magnetic Levitation Technology Extracorporeal Ventricular Assist Device and Dedicated Consumables

magAssist Officially Mentioned,MoyoAssist® is the first extracorporeal ventricular assist device and dedicated consumables in China to feature full magnetic levitation technology., the approval and market launch this time represent another new breakthrough in domestically produced high-end medical devices.

According to official data,MoyoAssist® is a state-of-the-art fully magnetically levitated centrifugal pump designed for short-to-medium-term extracorporeal ventricular assistance.

In responding to critical emergencies such as heart failure and cardiogenic shock, it can effectively provide temporary cardiac pumping function. By utilizing globally leading computational fluid dynamics technology and fully magnetic levitation technology, this product ensures excellent blood compatibility and can provide stable support for up to 30 days.

Moreover, it supports multiple usage modes, whether it's the inability to wean off extracorporeal circulation after cardiac surgery, transitioning to cardiac function recovery, or even bridging to other long-term alternative treatments. It can flexibly respond to various scenarios, providing great convenience and assurance for patients' treatment.

The clinical trial of MoyoAssist® was led by Professor Nian-Guo Dong, 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, as the principal investigator (PI), and received strong support from multiple clinical centers across China. In early last year, this clinical trial was successfully completed and obtained the "Innovative Medical Device" certification from the National Medical Products Administration.

▲ Image source: Official WeChat Account

Professor Dong Nianguo highly praised the device: "The MoyoAssist® Extracorporeal Full Magnetic Levitation Artificial Heart is characterized by minimal invasiveness, rapid recovery, and reasonable cost, providing an excellent bridging solution for heart transplant surgeries. For patients who temporarily cannot obtain a suitable donor heart, this is undoubtedly an accessible hope." Professor Dong further pointed out that this extracorporeal full magnetic levitation artificial heart, as a circulatory support device, can effectively replace ventricular function, which is of great significance for heart failure patients or those awaiting a heart transplant.

# Stand Out! Win the Oscar of Design

In March 2024, the list of winners for the 2024 German iF Design Award (iF DESIGN AWARD), known as the "Oscar" of the design world, was officially announced.

magAssist's Extracorporeal Maglev Artificial Heart MoyoAssist® Stands Out Among Over 10,000 Entries from 72 Countries, Winning the 2024 iF Design Award!

It is reported that the extracorporeal magnetic levitation artificial heart, MoyoAssist®, has successively won multiple domestic and international design awards, including the Use Category Winner of the Designers Australia Awards, the Good Design Awards Winner of the Australian Good Design Awards, and the Fortune China Best Design Award.

# Participate in the project!Awarded the Second Prize of National Science and Technology Progress

Not long ago, the Office of the National Science and Technology Awards recently released Announcement No. 100, which disclosed the preliminary review results, including 59 projects for the National Natural Science Award, 52 general projects for the National Technology Invention Award, and 132 general projects for the National Science and Technology Progress Award successfully passed the preliminary evaluation.

Among them, the project led by Professor Dong Nianguo's team from Wuhan Union Hospital and actively participated in by magAssist, "Key Technologies and Applications for End-Stage Heart Failure Surgical Treatment"Project, has won theSecond Prize of National Science and Technology Progress AwardThe honor.

The official public notice link is as follows for readers to review:
https://www.most.gov.cn/tztg/202404/t20240408_190162.html

The Natural Science Award, the Technology Invention Award, and the Science and Technology Progress Award are acclaimed as China's "National Three Major Awards." They represent the highest honors in the scientific and technological fields, showcasing the highest level of research in China and making significant contributions to national development. These three awards each have their own focus: the Natural Science Award centers on fundamental research and theoretical innovation, the Technology Invention Award emphasizes the practical value of scientific achievements, while the Science and Technology Progress Award focuses on the widespread promotion and application of these achievements.

magAssist's participation in the "Key Technologies and Applications for End-Stage Heart Failure Surgical Treatment" project has been awarded the Science and Technology Progress Award. This recognizes the significant market value and technological innovation achieved by the project in medical research and technology development. It also highlights the project's outstanding contributions to promoting the transformation of innovative achievements, application and promotion, as well as advancing the industrialization of high-tech.

# About magAssist

magAssist (Suzhou) Co., Ltd. was founded in May 2017 by a recipient of the National Talent Program,Led by Dr. Bo-Ling Xu, the first Chinese member of the International Society for Mechanical Circulatory Support (ISMCS) and Distinguished Professor at Soochow University, magAssist was co-founded with a top-tier team of experts from around the world who are dedicated to the development of artificial organs. The company is committed to building a next-generation extracorporeal life support platform for acute and critical care scenarios.

Since its establishment in 2017, magAssist has always adhered to the concept of "Technology Drives Life," successively developing products such as the extracorporeal fully magnetically levitated artificial heart, a new generation of extracorporeal membrane oxygenation system, minimally invasive interventional artificial heart, and warm blood organ transport platform. These products fill domestic gaps in China or have long been monopolized by imports, gradually expanding from the field of heart failure to multi-organ life support.

As of the date of publication, magAssist has received 7 rounds of financing. Details are as follows:

▲Data from the Internet

2024 Global MedTech List：Call for Entries: Awards Evaluation

2023Global Medical TechnologyList:Global Top 100 Medical Technology Companies | Industry Contribution Award | Technological Innovation Award | Tech Innovation Award | Innovative Medical Device Award

Global Medical Technology Industry Map: International Leaders

Cardiovascular:Medtronic｜Johnson & Johnson J&JMedTech｜BD Medical｜Boston Scientific｜Edwards Lifesciences｜Abbott｜Orthopedics:Medtronic｜Johnson & Johnson MedTech｜Stryker｜Smith & Nephew S&N｜Zimmer Biomet Ophthalmology:ESSILOR｜Alcon｜Carl Zeiss Medical |Topcon｜Cooper Medical Image:Siemens Healthineers｜Philips Medical｜GE Healthcare｜Olympus

Global Medical Technology Industry Map: Chinese Listed Companies

Global Medical Technology Industry Map: Industrial Clusters

Editor-in-Chief | Zhao Qing Reviewed by | Yi He