China's First Extracorporeal Fully Magnetically Levitated Artificial Heart, MoyoAssist®, Gains NMPA Approval, Matching Abbott's Performance at a Fraction of the Cost
magAssist
Developer of Extracorporeal Artificial Heart Devices
Source: Medical Device Business Review
Author: Jin Fan
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"China-Made 'Heart' Breakthrough: Racing Against 'Death', Extending Life!"
First Approved
Fully Magnetically Levitated Artificial Heart (Ex Vivo)
Recently (April 28), the National Medical Products Administration (NMPA) announced the official approval of magAssist (Suzhou) Co., Ltd. (hereinafter referred to as"magAssist") The independently developed and produced extracorporeal ventricular assist system by magAssist ——MoyoAssist® ProductRegistration Application, namely "Extracorporeal Artificial Heart".
Suzhou Daily reported that this is in ChinaThe First to Possess Full Magnetic Levitation TechnologymagAssist's extracorporeal ventricular assist device and dedicated consumables can provideProvide external mechanical circulatory support for the left ventricle, right ventricle, or biventricular in critically ill patients who require temporary cardiac pumping function due to heart failure, cardiogenic shock, etc., extending life.
For heart failure patients, heart transplantation is undoubtedly the most effective treatment. However, due to the scarcity of donor hearts, patients often face long waiting times.
In this process, clinicians often choose to use the Extracorporeal Membrane Oxygenation (ECMO) system to maintain the heart's pumping function in patients, buying more time for treatment.
However, when ECMO designed to maintain heart and lung function is used to provide ventricular assistance, blood flow is typically input from the heart's original blood output end.Easily increase the cardiac burden of heart failure patientsIn contrast, the extracorporeal artificial heart directly extracts blood from the heart to circulate it throughout the body.
In addition, when applied in the auxiliary treatment of acute heart failure, ECMO will also encounterAnticoagulation, hemolysis, and other issues, the current rates of weaning and discharge are also not ideal,Survival rate at discharge ranges from 20% to 80%.. Artificial lungs are prone to cause thrombosis, among other reasons,Resulting in ECMO's support for blood circulation typically not exceeding one week.
Therefore, the extracorporeal artificial heart undoubtedly addresses the unmet clinical needs in the field of heart failure treatment with precision, offering a better clinical option for patients with acute heart failure and those awaiting heart transplantation.
Product performance rivals Abbott
The cost is only 1/10 of an implantable artificial heart!
According to the data, the current global marketOnly one commercialized extracorporeal magnetic levitation artificial heart, which comes from the medical device giant Abbott's CentriMag product,magAssist's MoyoAssist® recently approved this time,Not only can it match CentriMag in key performance aspects, but it also demonstrates even better performance in shock resistance, anti-torsional swing, and portability.。
MoyoAssist®
MoyoAssist ® adopts globally advanced computational fluid dynamics technology and fully magnetic levitation technology, with no mechanical bearings, significantly reducing the formation of hemolysis and thrombosis. It has also achieved minimally invasive cannulation in clinical practice, skillfully combining an excellent fully magnetically levitated centrifugal pump with minimally invasive surgery.Not only can it ensure the safety of the surgery, but it also reduces trauma to the patient.。
MoyoAssist ® achieves international top-level blood compatibility,Can provide support for up to 30 days., stably supporting the possible cycles of Bridge-to-Recovery (BTR), Bridge-to-Transplant (BTT), and Bridge-to-Other-Therapies (BTD). Optimize the flow channel design for stable blood flow output, maintaining the patient's ideal mean arterial pressure to ensure effective organ perfusion.
Compared with CentriMag, MoyoAssist® can provide a maximum blood flow of 8L/min, reducing the system volume and weight while achieving the same level of hemocompatibility.Improved the shock resistance of the drive system, thereby enhancing the portability and usability of the device., can be applied in a wider range of clinical environments, such as emergency rooms, patient transport, and other complex scenarios.
Currently, MoyoAssist® has completed patient enrollment for all clinical trials across 12 centers in China, with overall treatment outcomes proving satisfactory. The clinical trial's principal investigator, Professor Nian-Guo Dong, has highly praised the results.
Extracorporeal Maglev Artificial Heart,Minimally invasive, fast recovery, reasonable price. Can serve as an excellent bridge to heart transplantation, allowing patients who temporarily cannot be matched with a donor heart to wait and have a viable option.
——Professor Dong Nianguo, Director of the Department of Cardiac and Great Vessel Surgery and Director of the Organ Transplantation Center at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
In an interview with Suzhou News, Yan Yifan, Vice President of R&D at magAssist, also revealed,Compared with implantable artificial hearts of the same type, the cost for patients using MoyoAssist ® is only one-tenth., fully demonstrating the reasonableness of MoyoAssist ® Extra-VAD pricing.
There is no doubt that the successful approval of MoyoAssist® this time not only fills the gap in China's extracorporeal magnetic levitation artificial heart field, but also represents a milestone in solving China's "bottleneck" technology issues. Moreover, it brings hope for survival to Chinese patients with heart failure or those awaiting a heart transplant.
Integration of Medicine and Engineering Accelerates Transformation
magAssist Fills Multiple Gaps in China-Produced Medical Devices!
Heart failure, with its high incidence and mortality rates, is known as "the last battlefield of cardiovascular diseases."”, has always been the golden track for major corporate competition.
And in this fiercely competitive environment, magAssist, founded just 7 years ago, aside from its newly approved MoyoAssist® External Magnetic Levitation Artificial Heart, has already broken into multiple uncharted areas in China's heart failure treatment device field with its unstoppable innovative strength, gaining high recognition in the global market.The company with the fastest-growing heart failure sector and the most comprehensive product line。
In the field of artificial hearts, interventional artificial hearts have always been a challenging area of research and development due to core design factors such as size and blood flow volume.Currently, only Johnson & Johnson's Impella CP device is available on the market globally, and it has not yet entered China.
magAssist's self-developed NyokAssist® interventional artificial heart product has entered the clinical stage, andSuccessfully Approved for Innovative Medical Device Special Review Channel in February This Year, the listing process has been fully accelerated.
At the same time, with its leading product design and excellent performance,Last August, NyokAssist® was awarded the FDA "Breakthrough Device" designation, becomingThe only interventional artificial heart product to simultaneously achieve "innovation approval in both China and the U.S.", providing a strong driving force for its promotion and access in the global market.
In addition, magAssist has also ventured into fields such as ECMO and organ transport platforms. Since its establishment, the company has submitted hundreds of patent applications, fully demonstrating its strong innovation capabilities and market competitiveness.
Currently, its newest generation of extracorporeal membrane oxygenation (ECMO) system, which is closest to the natural lung, has also been recognized as a national innovative medical device in China and has entered the "green channel" for market approval.
Dr. Xu Boshen, the founder of magAssist, once stated that magAssist has always regarded innovation as the foundation and gene for corporate development.Will ensure that there is one high-barrier key project initiated for R&D each year, and at least one high-barrier Class III product will be advanced to clinical trials annually.
Throughout the development of magAssist, as a relatively young enterprise, it has achieved numerous remarkable leaps in the highly challenging field of heart failure treatment. This is clearly inseparable from the strong support of its robust research and development team, operational team, and substantial capital backing.
Dr. Bo-Ling Xu, the founder of magAssist, is the first Chinese member of the International Society for Mechanical Circulatory Support (ISMCS), an authoritative organization in the field of artificial hearts.With nearly 16 years of experience in artificial heart research and development.
The product development team also includes experts with international influence and cutting-edge authority in the field of artificial hearts, such as the leader of the Cardiovascular Engineering Research Institute at RWTH Aachen University in Germany, the designer of the magnetic levitation total artificial heart BiVACOR, and an expert in power electronics and motor design from the University of Cambridge in the UK.
At the same time, in addition to putting great efforts into product innovation, magAssist has also chosen in clinical applications.The team of Academician Ge Junbo from the Cardiology Department of Zhongshan Hospital, Fudan University, the team of Professor Dong Nianguo from the Cardiovascular Surgery Department of Wuhan Union Hospital, etc.Top experts and scholars in cardiology and critical care medicine in China collaborate to achieve the integration and innovation of medical products through the intersection of medicine and engineering, precisely developing clinical products suitable for Chinese patients.
Besides the support from a professional team and strong innovative R&D capabilities, the development of magAssist has also been driven significantly by substantial capital investment.
According to Qichacha, magAssist has so farHas completed six rounds of financing, with a total amount reaching hundreds of millions of yuan., including nearly RMB 10 million in Series A, over RMB 100 million in Series B, and approximately RMB 500 million in Series C. It has not only attracted continuous investment from GQ Venture Capital, Taiyu Investment, etc., but also secured a leading investment from top-tier capital Sequoia China.
The high technical barriers, cutting-edge patented inventions, massive R&D investment, and top-tier talent have built magAssist an impregnable moat, making it a dark horse in the global heart failure medical device field.
A Blue Ocean Market of Nearly 60 Billion
"magAssist Leads Global Technological Breakthrough!"
According to statistics, there are currently about 22 million heart failure patients globally, of which 13 million are in China, with more than 700,000 being critically ill.
However, contrary to the data of 700,000 patients, in 2020, the number of heart transplant surgeries in China was only 564. Most patients still have to undergo a long waiting period. Artificial heart products have become a transitional or ultimate treatment option for such patients, giving rise to a billion-level golden market.
According to ReportLinker data, the global heart failure treatment device market is expected to reach $14 billion by 2025. Based on the number of patients, the commentator estimates,By 2025, the market for heart failure treatment devices in China will reach nearly 83 billion US dollars (approximately 600 billion RMB).。
But artificial hearts, due to their technical complexity and precision, have always been hailed as the "jewel in the crown" of the cardiovascular industry, with a development history that has been both tortuous and lengthy.
According to the data, artificial hearts have undergone three rounds of technological innovation.Compared with the first two generations of technology,The third-generation artificial heart product adopting full magnetic levitation technology has demonstratedBetter blood compatibility, longer working hours, lower equipment failure rate, better stability, and fewer patient complications, etc.，BecomeThe Current Mainstream in the Artificial Heart FieldTechnology。
Fortunately, although China started nearly a decade later than the United States and other developed countries in the research and development of artificial hearts, it has shown astonishing development speed. Currently, in the Chinese market, five artificial heart products have been approved for marketing. Particularly in the full magnetic levitation technology, China is leading the global market.
The CH-VAD Implantable Left Ventricular Assist System,自主研发的慈孚®植入式左心室辅助系统CH-VAD，是中国The First Chinese-Made Fully Magnetically Levitated Artificial Heart Approved by the National Medical Products Administration。
CH-VAD adopts internationally advanced full magnetic levitation technology, breaks through the bottleneck of blood pump size, effectively reduces implant invasiveness, and enhances anti-infection performance by using finer percutaneous cables.Moreover, in terms of key performance aspects such as system reliability and portability, it has reached the forefront level of the industry.
On June 6, 2023, the National Medical Products Administration approved the registration application for the innovative product "Corheart6 Implantable Left Ventricular Assist System" produced by magAssist.
It is reported that Corheart6 is the third-generation non-contact magnetic levitation centrifugal pump.Is currently the world's smallest and lightest implantable left ventricular assist device.Its blood pump has a diameter of only 34 millimeters, a thickness of 26 millimeters, and weighs about 90 grams. Compared with similar products on the market, the diameter is reduced by 40%, and the weight is reduced by 50%.
And the other three approved domestically produced artificial heart products are:
Clearly, in the field of artificial hearts, China has taken the lead globally, but we still cannot afford to be overly optimistic.
For example, in the field of implantable artificial hearts, only two products from YongRenxin have been approved in China for long-term support, while the rest have only received short-term support approval. In contrast, about 80% of artificial hearts in the United States are used for long-term support. Meanwhile, in the field of interventional artificial hearts, China still remains at a blank stage.
Although artificial hearts are made of cold metal, they carry the courage of humanity to face death and the awe for life. In the future, we will wait and see what exciting journey the "Chinese heart" will embark on.
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