"Life-saving artifact" now has "Made in China"

Courtesy of respondents

In recent years, due to clinical needs, artificial extracorporeal membrane oxygenation (ECMO) has gradually embarked on the road of localization. The sudden outbreak of new crown pneumonia has accelerated the research and development process of domestic ECMO. At present, in the field of domestic ECMO, OASSIST? The ECMO system is the first product of its kind to be registered, and is the first ECMO system in mainland China with complete independent intellectual property rights.

Recently, a patient with fulminant myocarditis in Fuwai Hospital of the Chinese Academy of Medical Sciences, with the support of domestic artificial extracorporeal membrane oxygenation (ECMO), achieved the recovery of cardiac function and successfully separated from ecMO. This is the first time that the domestic in vitro cardiopulmonary support auxiliary system has been applied to the clinic to help patients restore cardiac function.

ECMO is known as a "life-saving artifact"

ECMO is commonly known as artificial lung, which draws the venous blood in the human body out of the body, after the oxygenation of the artificial cardiopulmonary bypass of special material, and then injects blood into the patient's artery or venous system, providing a continuous oxygen supply for patients with severe cardiopulmonary failure, while discharging exhaust gases and maintaining the patient's life. In the global COVID-19 pandemic, ECMO provides respiratory support for severe COVID-19 patients and wins treatment time for patients, known as a "life-saving artifact".

According to the guidelines and expert consensus issued by the International In vitro life support organization (ELSO), the indications for ECMO are mainly cardiogenic shock caused by various causes, including acute myocardial infarction, fulminant myocarditis, cardiomyopathy, extracardiac surgery and heart transplantation, as well as respiratory failure caused by various causes, such as severe pneumonia, drowning, etc. ECMO, as an advanced technology in the field of emergency critical illness, represents the rescue level of critically ill patients in a hospital or even a region and a country.

However, ECMO is not used much in the mainland at present. According to the "2021 China Cardiovascular Disease Medical Quality Report", in 2020, a total of 443 hospitals in China carried out ECMO treatment, with a total of 5866 cases of ECMO. Taking Fuwai Hospital of the Chinese Academy of Medical Sciences as an example, Fuwai Hospital, as the largest cardiovascular disease center in China, has only used more than 500 cases in 18 years since the introduction of ECMO in 2003. However, according to the ECMO usage data of Fuwai Hospital from 2009 to 2019, the successful offline rate of patients is as high as 60%, which shows that the current management level of mature ECMO centers in China is almost the same as that of the international one.

The epidemic has accelerated the localization of ECMO

In recent years, due to clinical needs, ECMO has gradually embarked on the road of localization. The sudden outbreak of new crown pneumonia has accelerated the research and development process of domestic ECMO.

Ji Bingyang, director of the Extracorporeal Circulation Center of Fuwai Hospital of the Chinese Academy of Medical Sciences, told reporters that the basic structure of ECMO includes endovascular intubation, connection tube, centrifugal pump, membrane lung oxygenator, oxygen supply tube, monitoring system and so on. In order for China's ECMO to go to the market as soon as possible, it is necessary to "die" centrifugal pumps, membrane-lung oxygenators and other key core components of structural design and material research and development.

Centrifugal pumps and membrane-lung oxygenators are the two core components of ECMO. A centrifugal pump is a drive that drives the body's blood into the ECMO circulation. It is one of the difficulties that need to be overcome in the localization of ECMO, but at present, several domestic R & D companies have gradually overcome this problem.

Membrane lung oxygenator is used to achieve the exchange of carbon dioxide in the patient's blood and oxygen in the air, and its core technology is a special material - oxygenation membrane polymethylpentene membrane, also known as PMP membrane.

"There is only one supplier of this material in the world, which leads to limited production capacity. Therefore, PMP membranes can only be developed by ourselves. At the same time, membrane lung oxygenators and centrifugal pumps belong to the three types of medical devices, which are the most strictly controlled medical devices, which require a large number of clinical trials to be approved for marketing, but due to the small number of cases, clinical trials will last for a long time, resulting in delayed registration time. Ji Bingyang said.

At present, in the field of domestic ECMO, OASSIST? The ECMO system is the first product of its kind to be registered, and is the first ECMO system in mainland China with complete independent intellectual property rights.

“OASSIST？ The ECMO system was developed and stereotyped in 2019 and started type testing, in March 2020 was included in the emergency review and registration procedure of the State Food and Drug Administration, from October to December 2020, the National Center for Cardiovascular In Vivo Experiments and Evaluation conducted preclinical animal experiment evaluation and the first subject was included in December 2021, enrolled in the Fuwai Hospital of the Chinese Academy of Medical Sciences, and has now provided cardiopulmonary support assistance for two subjects in the clinic. Ji Bingyang said.

Ji Bingyang said that in the next step, Fuwai Hospital of the Chinese Academy of Medical Sciences will continue to escort patients with cardiovascular diseases and promote the localization process of critical care diagnosis and treatment equipment while improving diagnosis and treatment capabilities. (Reporter Ma Aiping)

Source: Science and Technology Daily