The artificial heart is one of the most complex and sophisticated medical devices, which is known as the “crown jewel” of the cardiovascular industry. Since former Soviet scientist Vladimir Demikhov successfully fitted dogs with artificial hearts for the first time in 1937, this field has attracted the attention of governments of different countries and the medical research community. It is difficult to develop artificial heart technology and the R&D threshold is high. In the eyes of many people, the development of artificial hearts is undoubtedly as difficult as successful landing on Mars. Although we haven’t landed on Mars so far, there’s plenty of good news in the field of artificial hearts: the world’s first artificial heart implant has been carried out in France, and the number of artificial heart implants continues to rise every year; the China made implantable left ventricular assist system developed by EVAHEART was approved to be launched to the market by the National Medical Products Administration in 2019; artificial hearts are being industrialized in the United States….At the same time, many outstanding artificial heart enterprises with international leading technology have emerged in China, including magAssist, EVAHEART, Tongxin Medical, Hexin Medical, Hangtian Taixin Technology and Jiuanxin. It’s noted that most of the artificial heart enterprises in China are devoted to the research and development of intracorporeal artificial hearts, while few are committed to the research and development of extracorporeal artificial hearts. Intracorporeal artificial hearts and extracorporeal artificial hearts are applied in different scenarios. Intracorporeal artificial hearts are used to perform the functions of heart in patients with end-stage chronic heart failure in the long term. Chronic heart failure is irreversible and develops in steps, which can be sustained by drugs in the early stages, but requires a heart transplant or an intracorporeal artificial heart in the later stages. Extracorporeal artificial hearts (short and medium-term cardiopulmonary bypass auxiliary devices) are applied to transitional treatment in patients with acute heart failure in the advanced stage, to replace the heart function in the short and medium term, so that the patients can pull through the dangerous period and recover. As one of the few Chinese enterprises in extracorporeal artificial hearts, magAssist has developed maglev extracorporeal artificial hearts on the basis of core platform technologies like mechatronics, maglev and computational fluid mechanics. It’s understood that this artificial heart has been properly designed and developed, to be put into clinical trials soon. Promoting the Domestication of Devices and Saving those Who Can be Saved. magAssist is headed by Dr. Po-Lin HSU, a special-term professor of Soochow University, composed of domestic and international teams long engaged in artificial heart research and development. Dr. HSU holds two doctoral degrees in electrical and medical engineering, one granted by the University of Cambridge and another by the RWTH Aachen University. She has been engaged in system design of artificial hearts and research on physiology of vital electrical system assisted by mechanical circulation. In the University of Cambridge, Dr. HSU designed and developed minimally invasive artificial hearts in the international forefront under the joint guidance of authoritative motor designer Dr. R. McMahon, cardiovascular medicine expert Dr. Saumarez and internationally renowned masters of fluid mechanics Professor W. Dose and L. Xu. The centralized parameter numerical model and experimental platform of human cardiovascular system developed by her can accurately simulate the blood pressure and blood flow status of local arteries and vital organs of the whole body as well as the ventricular output status, which is of important scientific significance and application value for the study of artificial heart hemodynamics and the extension of future application. This model was awarded with the Youth Research Scholar Award at the 2017 Annual Conference of the Japanese Society for Artificial Organs (JSAO). After gaining years of research experience overseas, Dr. HSU returned to China in September 2013 and has worked as a full-time professor in Soochow University. She has further expanded the research methods of electrophysiological system physiology, and further studied the physiological response and functional recovery indicators of the heart and circulatory system with the mechanical circulation support in Soochow University. This research was widely recognized by fellow experts and honored with the Nose International Scholar Award presented by the American Society for Artificial Internal Organs (ASAIO) in 2014, making Dr. HSU the only Chinese winning such honor in a span of ten years. In 2019, Dr. HSU was elected the first Chinese board member of the International Society for Mechanical Circulatory Support (ISMCS) since its establishment about 30 years ago. In 2017, Dr. HSU founded magAssist, and has been devoted to the research and development of extracorporeal artificial hearts ever since. According to Dr. HSU, she has a simple idea about establishing magAssist, “We hope to replace imported products with domestically made counterparts and save those who can be saved.” As estimated by WHO, cardiovascular diseases have become the world’s leading cause of death. As revealed by the China Cardiovascular Report 2018, China has 290 million cardiovascular disease patients, including 4.5 million heart failure patients. Acute heart failure is a critical illness caused by a variety of causes, including Acute large area myocardial infarction, severe acute myocarditis, myocardial strain and necrosis caused by drugs, systolic function decline caused by infective endocarditis. According to statistics, acute heart failure has become the leading cause of hospitalization in patients over 65 years old in China. Among the heart failure patients, 15% to 20% are new cases and a majority are cases of acute exacerbation of existing chronic heart failure. As a transitional treatment for acute heart failure, extracorporeal artificial hearts have great potential. For a long time, however, China has very limited choices of devices for critical illnesses, especially extracorporeal artificial hearts, most of which are imported. The imported devices are expense. Take the ultimate weapon ECMO in the ICU for example. There is a saying going that “when the ECMO is enabled, a million taels of gold will be spent.” It’s for this reason that Dr. HSU hopes to realize the replacement of imported devices with domestically made counterparts through entrepreneurship, thus relieve the burden of patients and prolong their life span. Furthermore, the domestication of devices can better satisfy the using habit of Chinese doctors, optimize product design and have patients benefit from the internationally advanced technologies. The idea of Dr. HSU won the support of her German mentors and co-workers, Dr. Ulrich Steinseifer and Dr. Kaufmann, who joined magAssist as co-founders. A guest professor of the RWTH Aachen University, the director of the Department of Cardiovascular Engineering of Helmholtz Center, the director of Medical Engineering Research Center of Monash University and one of the members formulating the European ISO standard for heart valves, Dr. Ulrich Steinseifer has nearly 30 years of experience in the development of cardiovascular prosthetic organs, and is particularly familiar with the development, certification and industrialization of artificial hearts and mechanical valves. He helped magAssist introduce a series of quality systems for the R&D and production of medical devices, providing strong support for magAssist’s product certification and industrialization in the future. As another co-founder of magAssist, Dr. Tim Kaufmann has mastered the most advanced cardiovascular computational fluid dynamics technology in the world. He founded ENMODES, a computational fluid dynamics company, and participated in several NIH artificial heart hydrodynamics evaluation projects. He has been deeply involved in the passageway design and optimization of magAssist’s products, and Enmodes has provided complete computing resources for magAssist, and completed the first round of fluid mechanics design. Furthermore, Enmodes has established parallel computing resources, trained professional engineers, and assisted in building fluid mechanics experimental platform for magAssist. Error! Filename not specified.
Establish an ECLS system layout centered on extracorporeal artificial heart. As the power source of the human body, the extracorporeal artificial heart is the most complex artificial organ to develop. It involves multi-disciplinary research and development in fluid mechanics, medicine, mechatronics, electronic circuit technology and control biomechanics, thus making it difficult to develop. According to Dr. Po-Lin HSU, the main technical challenge lies in system-level optimization. When all disciplines and all elements are integrated together, it is very difficult to carry out system-level optimization due to mutual restraint and interaction between them. “For instance, the smaller the gap, the higher the efficiency of electrical system and battery system, but it will cause the problem of blood damage. A large gap will not damage the blood, but lower the system efficiency, resulting in heating damage to the blood cells by the electrical system.” Fortunately, magAssist’s core team has rich design and R&D experience in vascular artificial organ, and upholds a good global concept. Under the concerted efforts of the domestic and international teams, magAssist has achieved a balance in system-level optimization, and successfully developed the maglev extracorporeal artificial heart. As revealed by Dr. Po-Lin HSU, the artificial heart of magAssist has been properly designed and developed and will be put into clinical trials soon. Error! File name unspecified. Maglev is a frontier trend of artificial heart today. “The artificial heart is, in essence, a rotatory pump. Traditional mechanical bearings have friction, which causes blood damage easily. The bearing of maglev extracorporeal artificial heart—the impeller rotor in the blood pump hovers within the pump body through the electromagnetic force, generating no mechanical wear, contact or friction, thus reducing the heat generated by friction and increasing blood compatibility. The problem of unsmooth blood flow is resolved, no obvious blood damage produced and product service life prolonged.” According to Dr. Po-Lin HSU, the maglev extracorporeal artificial heart of magAssist is benchmarked against CentriMag of Abbott. Test data reveal that the blood compatibility of magAssist’s extracorporeal artificial heart is comparable to that of Abbott products. In the animal experiments, magAssist’s products had no visible hemolysis, and all physiological indexes of the tested animals were good. Furthermore, magAssist believes that critical disease devices will be bound to expand beyond ICUs and operating rooms to the medical frontline in the future. Therefore, magAssist has made many upgrades and optimizations in terms of product portability and stability. As revealed by the data of the U.S. market research company Grand View Research, the global VAD market size reached USD 1.7 billion in 2019, which is expected to grow with a compound annual growth rate of 11.7%. Dr. Po-Lin HSU believes that the importance of artificial heart speaks for itself, and this field will grow with the increase of public awareness, improvement of medical systems, price reduction and technological progress. In the future, Dr. Po-Lin HSU reveals that magAssist will accelerate the clinical trials and subsequent launch of maglev extracorporeal artificial heart to gain a firm foothold in short and medium-term heart support. Meanwhile, magAssist will enter cardiopulmonary and other organ support fields based on maglev extracorporeal artificial heart, build a new-generation ECLS platform for critically ill patients, improve minimally invasive artificial heart and ECMO product lines, and serve the patients in China and in the world at large. Source: vcbeat.top