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Extracorporeal membrane oxygenation (ECMO), also known as leaf membrane and artificial membrane lung, is a cardiopulmonary circulation support system mainly used to treat cardiopulmonary failure and help patients relieve hypoxemia
caused by circulatory disorders.
The core components of ECMO include artificial heart (blood pump and pump drive) and artificial lung (membrane lung/membrane oxygenator), etc.
, with high technical barriers, and the suppliers are mainly European and American manufacturers
.
It is worth noting that in September this year, the first domestic integrated membrane oxygenator was approved for marketing
by the State Food and Drug Administration.
With the development and advancement of technology, local ECMO companies are making efforts to break through
.
ECMO indications are wide-ranging
Depending on the diversion pathway, ECMO is generally divided into two major modes: venous-vein (V-V) diversion and venous-arterial (V-A) diversion
.
Among them, V-V diversion only has respiratory assistance function, and the intubation methods include through the left femoral vein, right femoral vein or through the right internal jugular vein and right femoral vein; V-A diversion can provide both respiratory and circulatory assistance, with femoral vein, jugular vein, or right atrium for venous drainage routes, and femoral artery, carotid artery, and ascending aorta
for arterial return.
ECMO has a wide range of applications, and the indications corresponding to ECMO with different diversion pathways are also different
.
For example, V-V diversion is suitable for acute respiratory distress syndrome, bronchopleural fistula, refractory viral/bacterial pneumonia, acute lung injury, refractory hypoxia/hypercapnia, etc.
; V-A diversion is suitable for severe pulmonary embolism, refractory cardiogenic shock, refractory ventricular tachycardia, post-thoracotomy shock, hypothermia, etc
.
Application demand is growing year by year
In recent years, the global demand for ECMO applications has been growing
.
Statistics from the Global Extracorporeal Life Support Organization (ELSO) show that from 2017 to 2021, the number of patients using ECMO in the world reached 85,490, and the number is growing rapidly
.
China's ECMO application demand is also growing
year by year.
According to data released by the Extracorporeal Life Support Professional Committee of the Chinese Medical Doctor Association (CSECLS), in 2020, the number of ECMO applications reported to CSECLSS in China totaled 6,937, an increase of 6.
3% over 6,526 cases in 2019 (see figure for details).
CSECLSS data also shows that by the end of 2020, there were 500 institutions carrying out ECMO in China
.
In order to meet the strong demand for treatment, the number of institutions carrying out ECMO in China still needs to be further increased
.
From the perspective of patient age and indication distribution, adult patients account for the vast majority
.
At the same time, it should be noted that the number of pediatric ECMO cases carried out by non-pediatric specialized hospitals is gradually increasing, so the role of
ECMO in the treatment of pediatric critically ill patients should be emphasized.
ECMO treatment is expensive
At present, the common ECMO products in the global market mainly come from giants
such as McVier, Solin and Medtronic.
The membrane lung material used by ECMO manufacturers is solid hollow fiber membrane filament, which is mainly supplied
by Membrana, a subsidiary of 3M.
In China, the price of a single set of ECMO equipment ranges from
1 million yuan to 3 million yuan.
In addition to the price of the ECMO equipment itself, the actual treatment cost of ECMO also includes the cost of start-up, disposable consumables, testing, drugs, and professional management costs
.
Among them, ECMO's disposable consumables include centrifugal blood pumps, perfusion lines and membrane lungs, etc.
, and the consumables package is replaced according to the patient's condition, and the price of each copy ranges from
30,000 yuan to 60,000 yuan.
In addition, the specific cost of ECMO treatment is also related
to the patient's condition and whether there are complications.
At the same time, the operation of ECMO equipment is more complicated, and there are high requirements
for the level of medical personnel and hospital qualifications.
It is worth noting that in September 2020, the National Health Commission issued the "Code for the Management of Clinical Application of Extracorporeal Membrane Oxygenation (ECMO) Technology", aiming to strengthen the management of ECMO technology and standardize the clinical application
of ECMO.
The localization of ECMO is imperative
Since the current ECMO equipment and core consumables market is basically dominated by foreign companies, ECMO equipment costs and usage costs remain high, and ECMO localization is imperative
.
In recent years, many domestic universities and enterprises are actively carrying out ECMO research and development, and some have made breakthroughs
.
For example, Xi'an Jiaotong University is one of the first affiliated hospitals in China to carry out ECMO research and the first to develop medical devices such as membrane oxygenators and perfusion pipelines The cardiovascular team has more than 20 years of experience in the clinical application of ECMO and related research; Many companies such as Saiteng Medical and Hannuo Medical are committed to the research and development of ECMO systems and core components; In October 2021, MicroPort announced the wholly-owned acquisition of ECMO startup Hemovent, a German company whose product MOBYBOX System is the world's first ECMO system
that integrates blood pump and membrane lung.
It is worth noting that in September this year, the State Food and Drug Administration approved the registration of the innovative product "integrated membrane oxygenator" produced by Dongguan Kewei Medical Equipment Co.
, Ltd.
, which is the 179th innovative medical device
approved by the State Food and Drug Administration.
The product consists of an oxygenator assembly (integrated gas exchanger and heat exchanger) and an intravenous blood reservoir system with an integrated spiral guide structure
.
This structural design helps to reduce overall prefill and reduce hemodilution
in clinical applications.
In May 2020, the National Development and Reform Commission, the National Health Commission, and the State Administration of Traditional Chinese Medicine issued the Capacity Building Plan for Public Health Prevention, Control and Treatment (hereinafter referred to as the Plan), which shows that it is necessary to improve the urban infectious disease treatment network, strengthen the construction of intensive care units (ICUs), and allocate ECMO and other related equipment; Transform and upgrade major epidemic treatment bases, and configure necessary medical equipment
such as ECMO according to different scales and functions in the construction of intensive care units (ICUs).
According to the reference reserve list of emergency treatment materials for major epidemic treatment bases in the Plan, a single base should be equipped with at least 3 ECMOs (with 6 sets of consumables).
On the whole, although the domestic ECMO market share is still mainly occupied by foreign companies, with the strong support of relevant policies, the continuous improvement of the scientific research environment, and the development and progress of core technologies, the localization process of ECMO will continue to accelerate
.
In the future, the close coordination and mutual promotion of medical equipment and medical service models, and the establishment of a multi-dimensional medical and engineering collaborative innovation model, will effectively promote the development
of ECMO to new formats such as telemedicine, mobile medicine, and smart healthcare.
(This article is selected from the "Blue Book of Medical Devices: China Medical Device Industry Development Report (2022)" edited by Wang Baoting and Geng Hongwu)
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