Samsung Medical Center announced Monday that "ISOx," a cardiopulmonary oxygenator jointly developed with Insung Medical, has received approval from the Ministry of Food and Drug Safety (MFDS) as the first domestically produced device of its kind.
The cardiopulmonary oxygenator is a core component of ECMO (Extracorporeal Membrane Oxygenation), a life-support device that draws blood out of the patient's body in critical situations such as severe pneumonia, cardiopulmonary failure, or cardiac arrest, supplies the needed oxygen, and returns the blood to the patient. It performs the function of the lungs by supplying oxygen to the patient's blood and removing carbon dioxide for up to six hours.
Insung Medical led the project, while the research team headed by Cho Yang-hyun, professor of cardiac surgery at Samsung Medical Center, was responsible for in vitro performance testing and preclinical studies. Since Samsung Medical Center first introduced modern ECMO treatment in Korea in 2003, its experience of more than 2,500 cumulative treatments has been actively reflected in the design from the early stages of development, enhancing the product's commercialization potential.
The medical community views the development as the first step toward domestic production of oxygenators, which had been entirely dependent on imports, amid growing concerns over global supply chain instability. Expectations are also high that it will mark a turning point in establishing a stable supply system for cardiopulmonary oxygenators.
"As cardiopulmonary oxygenators are essential for treating critically ill patients, it is important to have a stable supply system," Cho said. "Since the localization of equipment that had been entirely dependent on imports has taken its first step, we expect it to help reduce supply instability and improve treatment continuity."
