"Surgical treatment of heart failure in China has entered the era of artificial heart!" A few days ago, at the Second Severe Cardiology Conference, Hu Shengshou, academician of the Chinese Academy of Engineering, director of the National Cardiovascular Disease Center, and president of Fuwai Hospital, said.
It is reported that Suzhou Tongxin Medical's innovative product "Implantable Left Ventricular Assist System CH-VAD" (artificial heart) has been approved for listing, which is the first fully magnetic levitation artificial heart officially listed in China.
The reporter learned that the artificial heart mainly provides mechanical support for blood circulation in patients with advanced refractory left heart failure for transitional treatment before heart transplantation or to restore heart function. Its core technology is mainly full magnetic suspension blood pump technology, which has obtained a number of patents in China and the United States, and is the first self-developed new generation of artificial heart in China. Previously, the world's only fully magnetic levitation artificial heart product came from Abbott in the United States.
Heart failure is the terminal stage of the development of heart disease, and as China enters the aging era, the prevalence and number of heart failure continue to increase. According to statistics, the number of cardiovascular diseases in China at this stage is 330 million, and nearly 10 million patients with central force failure.
"Heart failure is known as the 'cancer' of cardiovascular disease, with repeated conditions, multiple hospitalizations, low survival rates, and a heavy burden on public health resources." Hu Shengshou said that a large number of patients with end-stage heart failure need heart transplant treatment. However, there is a serious shortage of heart transplant donors, the supply exceeds the demand, and the beneficiary population is narrow, and the annual number of heart failure cases of heart transplantation treatment in China in 2020 is only 557. A significant proportion of patients die while waiting for a matching donor.
The development of artificial heart, which partially or completely replaces heart function, maintains blood circulation, allows patients to survive difficult periods, and buys more time for heart transplantation, which has become an urgent medical problem to be solved.
Industry experts said that the current ventricular assist device has three main clinical applications: "One is to wait for the transition of heart transplantation, to win more time for patients to wait for the appropriate donor; the second is to provide short-term replacement support for patients with acute heart failure, to be withdrawn after the heart function is restored; the third is to provide long-term replacement for patients with end-stage heart failure and support patients to carry artificial hearts for long-term survival." Long-term replacement therapy has become the mainstream clinical application of ventricular assist devices. ”
The artificial heart is one of the most technologically advanced medical devices, which has undergone three generations of development. The first generation in the 1990s was a large-volume pulsating blood flow device, the second generation in the early 21st century used an axial flow device, and the latest third generation was a magnetic levitation device.
Concentric Medical's fully magnetic suspension artificial heart "CH-VAD" belongs to the third generation and has achieved the characteristics of small size and good blood compatibility. From the realization of key structural design in 2011 to the approval of listing, this "Chinese heart" of Tongxin Medical has gone through 10 years.
This "Chinese heart" is only 26 millimeters thick, 50 millimeters in diameter, and weighs less than 180 grams. Compared with similar products in the United States, "Chinese Heart" has also established advantages in key performances such as surgical aggression, infection risk, and device reliability.
The global ventricular assist device market size is $1.7 billion in 2019 and is expected to grow at a CAGR of 11.7%. With the increase in people's awareness of treatment. With the advancement of technology and the decline in prices, the market size of the artificial heart field is further growing. Due to the high technical barriers of the full magnetic levitation artificial heart, which requires long-term technical accumulation, many companies in the early stage of the complete magnetic levitation artificial heart products have also appeared, but they have failed in the clinical trial stage. At present, only the fully magnetic levitation artificial heart of Abbott and Tongxin Medical in the United States in the United States has been approved for listing.
The reporter noted that another domestic enterprise, Xinqing Medical, has entered the clinical trial stage of in vitro magnetic levitation artificial heart products. In addition, a "Shenzhen Heart" is also preparing to launch multi-center clinical trials in 11 hospitals across the country. This artificial heart developed by the National Center for Cardiovascular Diseases, Fuwai Hospital of the Chinese Academy of Medical Sciences and Shenzhen Core Medical Care, weighs only 90 grams, which is currently the world's smallest and lightest magnetic levitation centrifugal artificial heart. With the research and development and listing of "Chinese hearts", the pattern of the global artificial heart market dominated by foreign countries will be rewritten in the future.
Image source: State Food and Drug Administration, Tongxin Medical
![【Medical Companion Travel】Breaking the monopoly of foreign countries, China's first domestic fully magnetic levitation artificial heart is listed[fig]](data:image/gif;base64,R0lGODlhAQABAIAAAP///wAAACwAAAAAAQABAAACAkQBADs=)