Recently, Medtronic, a medical device giant, announced the launch of the VitalFlow Extracorporeal Membrane Oxygenation (ECMO) System. This system is a configurable single-system ECMO solution that bridges the gap between bedside care and intra-hospital transport, offering doctors and clinicians an easier, more portable, and smarter ECMO experience.
Eight Years of Cooperation Bear Fruit
In March 2024, Medtronic completed the acquisition of MC3 Cardiopulmonary and subsequently launched the VitalFlow system. This acquisition marked the culmination of an eight-year partnership and distribution agreement between the two parties, during which they jointly introduced seven new ECMO (Extracorporeal Membrane Oxygenation) products. Prior to this, MC3 Cardiopulmonary was responsible for the development and manufacturing of ECMO products, while Medtronic held exclusive distribution rights.
Karim Bandali, President of Cardiac Surgery Business at Medtronic's Cardiovascular Portfolio, stated: "The launch of the VitalFlow system reflects Medtronic's commitment to developing life-saving cardiopulmonary medical devices to address the clinical needs of acute and chronic cardiopulmonary diseases. This not only reinforces our dedication in this critical area but also further expands our product line, including the recently acquired Viant Medical contract manufacturing site and the Penditure Left Atrial Appendage Occlusion System. We will continue to deliver bold and original innovations to clinicians worldwide, aiming to meet diverse clinical needs while enhancing our ability to serve cardiac surgery patients."
The VitalFlow system is equipped with a touch screen, capable of centrally displaying real-time performance data, highly configurable, and incorporates the proven Medtronic Nautilus ECMO oxygenator design, making it particularly suitable for long-term use.
Bandali added, "By extensively gathering input from hundreds of clinicians with diverse ECMO expertise, we have specifically designed solutions to address the most pressing challenges in ECMO systems—namely, simplicity, configurability, and performance. The ease of use of the VitalFlow system allows users of varying proficiency levels to confidently and efficiently serve patients. It is portable, can be easily moved between departments within the hospital, and ensures durability and reliability."
Medtronic Chief Medical Officer of Cardiac Surgery, Pieter Kappetein, noted: "The needs of clinicians in the ECMO field are continuously evolving. As patient conditions become more complex, the demand for innovative solutions that can address multiple disease states and comprehensive support is increasing. Clinicians have high expectations of Medtronic, and we are well-positioned to meet these needs, advance treatment methods, and ultimately better serve patients."
"Luxurious" "Life-Saving Wonder"
ECMO (Extracorporeal Membrane Oxygenation), also known as "artificial heart-lung," is a medical emergency device used to provide long-term extracorporeal circulation support for patients with heart and lung failure. It can offer necessary respiratory and circulatory support to help sustain life, buying more time for doctors to treat the primary disease, and is regarded as the "last line of defense" in treating patients with heart and lung failure.
▲Figure: Shutterstock
The ECMO system mainly includes a power pump, oxygenator, control system, disposable consumables, and auxiliary equipment. To facilitate rapid response in emergencies, the system is designed to be easily mobile, while separating reusable and disposable components to ensure safety and efficiency.
In the ECMO system, the most critical components are the membrane lung and the blood pump, which simulate the functions of the lungs and heart, respectively. The power pump is responsible for driving blood flow through the tubing, similar to the role of the heart. In clinical applications, centrifugal pumps are more commonly used due to their ease of installation, portability, and minimal blood damage, although roller pumps are also used in some cases. However, the latter is less common because they are not easily portable and are more difficult to manage.
ECMO gained widespread fame during the 2020 pandemic for saving numerous critically ill COVID-19 patients, earning it the title of "life-saving miracle device." Known for its life-saving capabilities, remarkable effectiveness, and extraordinary cost, a single ECMO machine typically ranges from 1 to 3 million yuan. According to a procurement announcement published on the China Government Procurement Network on June 23, 2022, the winning bid for Huashan Hospital Affiliated with Fudan University’s ECMO purchase was 2.5 million yuan per unit. In addition to the initial equipment cost, ECMO operation also requires expensive auxiliary consumables, leading to the saying, “When ECMO starts, gold flows like water.”
From 0 to 1 in China's ECMO Market
As the most advanced technology in the field of emergency and critical care, ECMO represents the level of rescue for critically ill patients in a hospital, a region, or even a country. For a long time previously, the design, development, manufacturing, and core raw materials of ECMO equipment worldwide were monopolized by European and American countries.
According to statistics, the global ECMO market revenue reached approximately US$247 million in 2016, with an average annual compound growth rate of 3.16% from 2012 to 2016. It is expected that by 2026, the market size will increase to US$377.8 million. The current scale of China's ECMO market is about 240 million yuan, with a potential market reaching 1.8 billion yuan. Currently, this market is mainly monopolized by three companies: Medtronic from the United States, Sorin from Germany, and Maquet from Germany. Among them, Maquet’s ECMO is the most mainstream, occupying about 80% of the domestic market share. Other participants mostly only produce parts and do not have the capability to develop complete ECMO systems.
According to the "2021 China Cardiovascular Disease Medical Quality Report," in 2020, a total of 443 hospitals in China performed ECMO treatments, with 5,866 cases utilizing ECMO. Taking Fuwai Hospital as an example, as the largest cardiovascular center in China, since the introduction of ECMO in 2003, the hospital has used ECMO in only over 500 cases in 18 years. The high cost is the main factor limiting its widespread application. To reduce costs and improve patient acceptance, the country is actively promoting the domestic production of ECMO equipment.
In May 2020, the Ministry of Science and Technology launched the "ECMO System Research and Development" National Key R&D Program; in the same June, the "14th Five-Year Plan" released by the state also emphasized the importance of strengthening the allocation of key medical equipment, including ECMO. Although most domestic manufacturers are still in the early stages of development, with strong government support, China has achieved a breakthrough from 0 to 1 in the independent research and development of ECMO:
- In January 2023, China's first domestically produced ECMO system was approved for marketing.
On January 4, the National Medical Products Administration (NMPA) granted emergency approval, after review, to Shenzhen Hannuo Medical Technology Co., Ltd. for the registration of its extracorporeal cardiopulmonary support device and disposable membrane oxygenator kits. When used together, these devices are intended for adult patients with acute respiratory failure or acute cardiopulmonary failure whose conditions are difficult to control with other treatments and who face foreseeable continuous deterioration or risk of death.
▲Hannuo LifemotionⓇChina-produced ECMO System
- In January of the same year, the second ECMO product manufactured in China was approved.
On January 17, the National Medical Products Administration (NMPA) announced significant news, granting emergency approval for the registration and market launch application of the extracorporeal lung support device developed by Changzheng Medical Equipment (Beijing) Co., Ltd. (referred to as: Changzheng Medical). Official information shows that this is the second approved ECMO product manufactured in China, named HuiSheng-I ECMO. The technology of this product is independently controllable with full intellectual property rights.
Dripping water can wear through stone, but not in a single day. Medical R&D achievements need to be transformed into clinical products to demonstrate their value. Thanks to policy support and technological advancements, China's ECMO market is expected to experience rapid growth. In the future, we also look forward to the cooperation and competition between international companies like Medtronic and local enterprises, promoting global ECMO technology progress and providing better treatment for critically ill patients. As the technology matures, ECMO will play a crucial role in more emergency and critical care treatments, becoming an important guardian of life.
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