Published Date: June 21, 2019 Source: CCTV Finance
For patients with advanced heart failure disease, there are few donated hearts available for heart transplant, and the sources may not be reliable. Now, these patients have another option: a miracle LVAD. The LVAD, called the "Chinese Heart", has successfully helped several patients with heart failure to return to normal lives. Seven cases of totally magnetic levitation VAD surgery have been successfully performed in China.
Xin He, 29 years old, is a heart failure patient from Tangshan, Hebei province, Xin often felt very tired due to heart problems. Sometimes he had difficulty breathing and had to lie in bed to rest. Xin underwent surgery at Fuwai Hospital more than two months ago to have a full magnetic levitation VAD implanted as the first patient in the clinical trial. Xin said that he used to get panting badly after a twenty to thirty meters walk prior to the surgery, now he feels at ease walking 1,000 or 800 meters, and he can walk up the stairs by himself without any help.
Professor Shengshou Hu, Member of Chinese Academy of Engineering, the president of Fuwei Hospital and Xin's chief surgeon, introduced that the full magnetic levitation VAD in Xin's body is device developed domestically in China. Its performance indicators are comparable to international standards and it is affectionately known as the "Chinese Heart" in the medical community. It not only fills the gap in the field of LVAD in China, but also brings hope to millions of patients with advanced heart failure.
Statistical data analysis shows that China has at least 10 million patients with heart failure. There are two therapies for heart failure patients. One is heart transplantation. However, there are only about 300 donor hearts available for transplantation in China every year, which is almost negligible compared to ten million patients. The second method is an “LVAD”. Dr. Chen, CEO of CH Biomedical, said: "The full magnetic levitation VAD, which is only 26 millimeters thick, 50 millimeters in diameter and weighs less than 180 grams, is the most watched LVAD in the world.
Chen, who has been working on LVADs for nearly 30 years, is a leader in the research and development of all-magnetic levitation LVADs. In 2008, Chen Chen established the company to develop full magnetic levitation LVAD independently with creative ideas.
Since the 1950s, scientists had begun to study LVADs. From the first generation of bionic LVAD, which initially imitated the structure of the human heart, to the second generation of functional LVAD, and then evolved to the current third generation of full magnetic levitation LVAD, every leap had been a huge scientific innovation. The patient with the full magnetic levitation LVAD can even take part in physical exercise.
The pump is the core part of the full magnetic levitation VAD LVAS. One of the most difficult challenges in developing an all-magnetic levitation VAD is to minimize the size of the pump while ensuring its high efficiency.
Chen and his team creatively utilized the different properties of permanent magnets and electromagnets with optimized arrangement to reduce the size and power consumption of the electromagnet, thus reducing the diameter of the gear and the overall size of the pump. The pump diameter, originally 60 or 70 millimeters was down to 50 millimeters, thickness of pump was down to 26 millimeters.
Not only that, but Chen’s team also solved the second major problem – hemocompatibility issue by allowing blood to pass through the pump at high speed, thus preventing thrombosis. This design created a great challenge in the production process of the pump. Chen Chen said that requirement for the sealing of the pump is very high, it will take hundreds of years for a small air bubble to penetrate the sealing of product.
In 2011, Chen Chen's team independently developed China's first full magnetic levitation VAD after hundreds of repeated experiments, including testing, adjusting, verifying. The project was listed as one of the National Key Scientific and Technological Projects (NKSTP) by the Ministry of Science and Technology, China
In 2013, Chen was invited to attend the International Conference of LVAD in Los Angeles, the United States. As soon as the little "Chinese Heart" showed up at the conference, foreign peers immediately realized that a “Chinese black horse” had emerged in the field of full magnetic levitation LVAD. Later, Chen's team worked with the State Key Laboratory of Cardiovascular Diseases (SKLCD) and other institutions to further improve the full maglev VAD. In 2015, a fully magnetically levitated VAD with a diameter of 50 millimeters, a thickness of 26 millimeters and a weight of less than 180 grams was finalized. This “LVAD” with completely independent intellectual property rights soon attracted the attention of peers around the world.
In November 2018, Chen was invited to attend the 26th International Society for Mechanical Circulation Conference held in Tokyo, Japan. It was the first time that a representative of Chinese enterprise made a speech at the conference in its 26-year history.
In 2019, a study published by the University of Maryland showed that compared with the two most widely used VADs in the world, the main indicators of the fully -magnetically levitated VAD developed by Chen's team reached or were superior to the competitor’s product specifications.
American Professor Dr. Richard Wampler, known as the "Father of Rotary VAD", visited Chen Chen’s company twice and left a message: “I am excited and respectful to you for such a remarkable device”.
At present, “China Heart”, the fully magnetically levitated LVAD developed independently by China has been successfully implanted for 4 patients of the ongoing clinical trial and 3 humanitarian uses in a total of 7 cases. Chen's best hope is to bring the good news to more patients with advanced heart failure through continuous technological innovation.
2023年8月7日,《人民日报》发表题为《国产全磁悬浮人工心脏服务患者》的报道,对同心医疗打破国际技术垄断,研发出自主知识产权的全磁悬浮人工心脏表示肯定。目前该产品已经覆盖全国近40家医院,让140多名终末期心衰患者开启了“心”生活。
近日,在被誉为医学界最高级别大会的“2022中国医学发展大会”上,中国医学科学院发布了《中国21世纪重要医学成就》和《中国2021年度重要医学进展》。作为全球VAD领域的技术突破者,同心医疗自主研发的“慈孚植入式左心室辅助系统获批上市”(国械注准20213120987)入选《中国2021年度重要医学进展》。
2021年11月24日,同心医疗自主研发的CH-VAD植入式左心室辅助系统正式获得国家药品监督管理局(NMPA)批准上市(注册证号:国械注准20213120987)。这是我国首个获得NMPA批准的拥有完备自主知识产权的国产人工心脏,也是全球范围内首个获得NMPA批准的全磁悬浮式人工心脏,标志着全球新一代技术路线(全磁悬浮技术路线)的心室辅助装置产品在中国商业化落地。