Breaking through the technology monopoly of Europe and the United States, the domestic maglev artificial heart breaks through again

  "I am in good physical condition now, and I can also participate in some less strenuous exercises." A year ago, Ms. Li from Dongxihu District, Wuhan City, Hubei Province suffered from fulminant myocarditis and developed heart failure. After being implanted with a domestically produced full magnetic levitation artificial heart, Ms. Li is now able to lead a normal life.

  Heart failure is a major challenge in global medicine. According to statistics, the prevalence rate of heart failure among adults in my country is 1.3%, and the corresponding number reaches 13.7 million. After the development of heart failure to the end stage, the treatment and management methods are extremely limited. Heart transplantation is recognized as an effective treatment, but currently only hundreds of heart transplants can be performed in my country every year. Compared with the hundreds of thousands of patients who may benefit from heart transplantation, the role of heart transplantation is a drop in the bucket. With the development of modern science and technology, artificial heart has gradually become an important means of treating end-stage heart failure. However, the artificial heart has extremely high technical barriers and is known as the "crown jewel" of the cardiovascular industry.

  In the artificial heart track, my country's artificial heart track has experienced ten years of rapid development, and a number of outstanding players have emerged. The mainstream technology of artificial heart has undergone several evolutions, and the current mainstream technology of rotating artificial heart has developed into the third generation. Among them, the full magnetic levitation artificial heart is one of the mainstream technologies. The survival rate of patients with artificial heart with full magnetic levitation technology is high, and the incidence of complications is significantly lower at the same time.

  The Cifu® Implantable Left Ventricular Assist System of Tongxin Medical is the leader of the full magnetic levitation artificial heart. With the international leading level of the product in terms of key performance indicators, it has become the benchmark for the technical development of the full magnetic levitation artificial heart industry.

  There is a metal tube on the round body, made of titanium alloy, weighing 186 grams, and can provide a flow rate of up to 10L. In the exhibition hall of Tongxin Medical, the ventricular assist system "Cifu", which looks like a snail, represents the advanced technology level of the industry.

        Picture: Concentric Medical's "Implantable Left Ventricular Assist System"

  The artificial heart is essentially a blood pump. The blood pump is the core component of the artificial heart. It draws blood from the heart, raises the pressure, and transports it to the aorta, thereby partially or completely replacing the blood supply function of the natural heart. Over the past half a century, the industry technology of artificial heart has undergone many changes, from the pulsating blood pump that imitated the action of the heart in the early stage to the rotary blood pump that pursues the overall function of the heart. A handful of companies in the world have promoted new products to the stage of clinical trials or marketing. The Cifu® Implantable Left Ventricular Assist System (abbreviation: Cifu® VAD) independently developed by Tongxin Medical was approved in 2021 and obtained the first registration certificate for a domestically produced maglev artificial heart.

  In June 2023, the Corheart® 6 implantable left ventricular assist system independently developed by Shenzhen Core Medical Technology Co., Ltd. was also officially approved by the National Medical Products Administration (NMPA) for marketing. Corheart6, like the Cifu® Implantable Left Ventricular Assist System independently developed by Tongxin Medical, also uses magnetic levitation technology, which is a magnetic levitation artificial heart.

        Picture: Corheart 6, a fully magnetic levitation artificial heart of Core Medical

  According to the core medical website, the Corheart6 blood pump produced by core medical is 40% smaller in diameter and 50% lighter than similar products. Independently developed by Shenzhen Core Medical, it is currently the world's smallest and lightest artificial heart. Corheart6 artificial heart is an artificial heart product specially designed for the treatment of children with heart failure. According to expert feedback, the product is small in size and has a small flow rate, about 2L-4L, which is just suitable for small babies and children, and it is just enough to assist children. It is also suitable for some women with smaller stature.

At the same time, the weight of the core medical battery is relatively light, which has little impact on daily life. Although the battery life is short, because infants and young children need less flow and the range of activities is small, they do not need too much battery life.

  In June 2022, the team of Academician Hu Shengshou of Fuwai Hospital, Chinese Academy of Medical Sciences successfully implanted Corheart® 6 into a 14-year-old child with end-stage heart failure, realizing a leap from scratch in the clinical application of left ventricular assist in children in my country . On February 25, 2023, a 12-year-old child with end-stage heart failure weighing only 30.2 kg in Binjiang District of Zhejiang University Children’s Hospital successfully implanted Corheart® 6, which once again refreshed the domestic artificial heart implantation surgery Minimum age and minimum weight records. After 2 months of rehabilitation after the operation, the child is now able to live a life close to normal, and his heart function has returned to the level of II.

  However, judging from the current status of technological development, if the artificial heart wants to permanently replace the human heart, it still needs to overcome many technical difficulties, such as longer life, smaller size, longer battery life, etc. In the past ten years, my country has achieved breakthroughs in some key core technology fields, and strategic emerging industries have grown stronger, such as manned spaceflight, lunar exploration and fire detection, deep-sea and deep-earth exploration, supercomputers, satellite navigation, quantum information, nuclear power technology, and large aircraft. Significant achievements have been made in fields such as manufacturing and biomedicine, and China has entered the ranks of innovative countries. We have reason to believe that the future of Chinese technology can design a more promising artificial heart, and the future of domestic medical devices can be expected.

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