On March 22, 2022, the kick-off ceremony of the cooperation project on Extracorporeal Membrane Oxygenation (ECMO) and relevant accessories was held online by Beijing Anzhen Hospital of Capital Medical University (hereinafter referred to as the Anzhen Hospital) and Suzhou magAssist Co., Ltd. (hereinafter referred to as magAssist).
Dr. Hongjia Zhang, Deputy Secretary of the party committee and President of the Anzhen Hospital, Dr. Xiaotong Hou, Head of the cooperation project and Deputy President of the Anzhen Hospital, and Dr. Polin Hsu, clinical expert of the ECMO project team and founder of magAssist, as well as the R&D and medical device registration team attended the ceremony. The ECMO system was developed based on the third generation of the full-maglev system, and has reached or surpassed the standards of the best-selling second generation ECMO in hemolysis and clotting performance, gas exchange rate, oxygenator pressure drop, and other main technical indicators.
At the ceremony, both sides introduced the makeup of the team and the division of labor. Dr. Polin Hsu from magAssist then reported the latest development of the project and R&D plans for the future. Participants also proffered constructive suggestions on the clinical applications of the product and set up related clinical standards, design goals, and R&D plans after heated discussions.
President Hongjia Zhangextended warm support for the project. Dr. Zhang stated that the goal is to better serve Chinese patients by expanding China's clinical resources. This cooperation project is to develop equipment and consumable items with fully independent intellectual property rights. By synergizing the advantages of the Anzhen Hospital in clinical experience and magAssist in R&D, the ECMO team could more efficiently make breakthroughs in technology bottlenecks. In addition, Zhang urged the team to continuously optimize the product during clinical application. Only in this way can we create the next-generation product that meets future needs and has the ability to go global and become the benchmark for relevant technical innovation.
Deputy president Xiaotong Hou also encouraged hospitals to join hands with companies on achieving breakthroughs in China’s key medical technologies. The ECMO team should strive to make the project an exemplary model for medical technology innovation and contribute to the development of the country's medical equipment industry and the commercialization of relevant products. "It is such an exciting thing for doctors who have been studying ECMO for years to make a product that is independently developed to fill the market gap. The project provides us an opportunity to jointly work for our shared ideal," he said in the concluding remarks while expressing high expectations on both sides of the team.
Dr. Polin Hsu explained that by leveraging the clinical and academic resources of the influential Anzhen Hospital, and based on the optimization and retrofitting of the current full-maglev ventricular assist system, magAssist will try to tackle the most challenging technical difficulty of multiphase fluid mechanics in artificial lung design, strive to integrate the artificial heart and lung systems and enhance the clinical performance and the safety of ECMO. Meanwhile, the company will also try to make nursing care smarter and more tailored to the patient's needs, thus reducing the cost of training.
ECMO, the extracorporeal life-support system outside the operating room
In June 2020, the Ministry of Science and Technology released the Application Guidelines for the 2020 “Technology and Equipment for Public Security Risk Prevention and Control and Emergency Response” Key Special Project and earmarked 20 million RMB to support the R&D of ECMO: since the outbreak of the COVID-19 pandemic, ECMO has played an important role in treating severe COVID-19 cases. To address the shortage of technological know-how and weak R&D and industrial foundation, It is urgently needed to improve the technical performance and the quality of ECMO, and strengthen the innovation capability of companies to better meet the needs of clinical and scientific research in China.
The Extra Corporeal Membrane Oxygenation (ECMO) is also named Extra Corporeal Life Support (ECLS). This therapeutic technology provides external respiration and blood circulation and thus is also aptly called the “last line of defense” to safeguard the lives of patients with cardiopulmonary failure.
A standard ECMO circuit consists of a blood pump (artificial heart), oxygenator (artificial lung), oxygen tubes, monitoring system, cannulas, and connecting tubes. When it comes to clinical use, a cluster of disposable parts usually comes in kits, while the non-disposable parts would be tied up. The ECMO machine is also set on runners to make it more convenient in emergency settings. The most important components of an ECMO are the blood pump (centrifugal pump) and the membrane oxygenator, which function as an artificial heart and artificial lung. For patients with severe cardiopulmonary failure, it provides a relatively long-term replacement that keeps the functions of the heart and lungs going to win time for doctors to treat their underlying problem.
The basic principle of ECMO is to collect the patient’s venous blood via a special heart-lung bypass connected to an oxygenator and re-infuse the oxygenated blood into the patient's arterial or venous system. It is a machine that takes over heart and lung function and sustains the oxygenation and blood supply of visceral organs.
ECMO remains a 'niche' medical technology, given that there were only 10423 reported cases of ECMO support around the world in 2018. ECMO treatment in China has been rapidly developing along with the popularity of ICU, with a total of 3923 cases reported by 260 hospitals in the same year, a large increase compared to previous years. In China, there are around 330 million patients with cardiovascular diseases, and many of them suffer from chronic obstructive pulmonary disease (COPD). Considering the potential growth in the number of patients with respiratory failure in the future, China is in urgent need of ECMO devices, especially in grassroots areas. Back in 2020, after the outbreak of the COVID-19 pandemic, there were only around 400 ECMO devices around China. Medical teams from other provinces had to bring their own ECMO devices to Wuhan, which is why the R&D of ECMO has attracted much attention since the beginning of the pandemic.
The Anzhen Hospital and magAssist are fully aware of the urgent need and the importance of research and development of ECMO and are committed to providing more effective and reliable medical resources and treatment options for Chinese patients as soon as possible.
The animal experiment has proven that the ECMO system can operate smoothly and has reached international standards.
Anzhen Hospital was among the first batch of hospitals to adopt ECMO technology in China. After 20 years of development, it is now home to the Beijing Extracorporeal Life-support Quality Control and Improvement Center. It was also the first to use ECMO to treat patients with low cardiac output syndrome in 2004 and has expanded the use of ECMO therapy on severe patients with acute myocardial infarction complicated by cardiogenic shock, sudden cardiac arrest, fulminant myocarditis, acute multiple trauma, virus-induced ARDS, as well as on critically ill pregnant and birth giving women. Over the years, the ECMO team from Anzhen Hospital has won many medical prizes, including the First Prize in Science and Technology of the Beijing Branch of the Chinese Medical Association, the Second Prize in Science and Technology Progress of Beijing Municipality, and the "Most Influential ECMO Award" of Chinese Medical Doctor Association. In 2018, it has even become the first and the only institution in Chinese mainland to win the "Center of Excellence-Gold Level" awarded by the Extracorporeal Life Support Organization.
In recent years, led by Deputy President Xiaotong Hou, the ECMO team continues to challenge technical barriers in the field of life support and has saved many lives using ECMO. After the outbreak of the COVID-19 pandemic, Anzhen hospital timely sent out an ECMO team to Beijing Youan Hospital to help treat severe COVID-19 patients. While carrying out clinical research, the ECMO team is also committed to the R&D of medical equipment, technical innovation, and scientific research, and has made breakthroughs in ECMO-induced lower limb ischemia, hypoxia of the upper body, and other difficulties.
Before collaborating with Anzhen Hospital, magAssist has already created China's first extracorporeal ventricular assist device, MoyoAssist Extra-VAD and had gone through successful clinical trials. Moving forward, magAssist and Anzhen Hospital have jointly launched an independently developed highly portable ECMO system that is suitable for on-field treatment. The technological know-how and R&D resources of magAssist will be of great help for the development of the new generation of ECMO. On February 19, 2020, the company's project-Development of ECMO products for critical COVID-19 treatment-was awarded for 2020 Coronavirus Emergency Prevention and Control Technology Project by the Suzhou Municipal Science and Technology Bureau. In 2021, the project team has carried out animal experiments, verified the various performances of the product, and collected advice and suggestion from doctors on product structure, performance, and operations. The animal experiment has proven that the ECMO system can operate smoothly and its performance is highly competitive around the world.