Samsung Medical Center and Insung Medical have succeeded in localizing for the first time a core component of the extracorporeal membrane oxygenation (ECMO) device, which had previously been entirely dependent on imports.
Samsung Medical Center announced Monday that its cardiopulmonary oxygenator (product name: ISOx), jointly developed with Insung Medical with support from the Korea Medical Device Development Fund and the Ministry of Food and Drug Safety's medical device localization support consortium, has received approval from the Ministry of Food and Drug Safety (MFDS).
ECMO is a device that draws blood out of the patient's body in emergency situations such as severe pneumonia, cardiopulmonary failure, or cardiac arrest, supplies oxygen that is lacking, and returns the blood to the patient's body. The device gained public recognition as a life-support system, with its importance highlighted each time epidemic respiratory diseases such as COVID-19, SARS, and MERS became major issues. The cardiopulmonary oxygenator is an essential device for extracorporeal circulation treatments, including ECMO. It substitutes for lung function by supplying oxygen to the patient's blood and removing carbon dioxide for up to six hours.
Oxygenators used in Korea have been entirely imported, and securing stable supply has emerged as a critical challenge amid mounting concerns over global supply chain instability. The medical community has high expectations that the first commercialization of a domestically developed product will mark a turning point in establishing a stable supply system for cardiopulmonary oxygenators.
Professor Cho Yang-hyun of Samsung Medical Center's Cardiac Surgery Department is regarded as a key contributor to the commercialization process, reflecting clinical experience in the design from the early stages of development and leading in-vitro performance tests and preclinical trials. Samsung Medical Center's experience of more than 2,500 cumulative treatments since introducing modern ECMO therapy for the first time in Korea in 2003 also served as a foundation.
"Cardiopulmonary oxygenators are essential for treating critically ill patients, so establishing a stable supply system is important," Cho said. "As the localization of equipment that had been entirely dependent on imports has taken its first step, we expect it will help reduce supply instability and enhance continuity of treatment."
