Xenios AG Receives Chinese Approval for ECMO Devices

 Xenios AG, a Fresenius Medical Care company, has received approval from the National Medical Products Administration (NMPA) in China for the Xenios console and patient kits for ECMO therapy.

The approval for two patient kits in China follows NMPA’s approval of the Xenios console in December 2020. As a result, a complete Xenios system is now permitted for ECMO therapy in China.

Xenios received the approval through a process called “Fast Registration.” This expedited process is only offered for products that, for example, are urgently needed for clinical use and can treat serious, life-threatening diseases. This Xenios ECMO complete system is certified in China for nine days application period. It is also the first ever “Fast Registration” for new imported medical devices in China.

“We are particularly proud to have received this approval,” said Jörg Buschbell, CEO of Xenios AG. “In just over a year, we have gained access not only to the U.S. market, but also to the Chinese market for our ECMO therapy products. This marks another milestone for Xenios AG and Fresenius Medical Care.”

“The expedited approval was a joint effort by Xenios and Fresenius Medical Care China Team. Since the beginning of the pandemic, they strived to make our advanced critical care products available in China for treating the critically ill patients,” said Harry De Wit, president and CEO of Fresenius Medical Care Asia Pacific. “The approval means that we will be able to support the Chinese critical care community further with our advanced developments, ultimately benefitting the patients.”

ECMO stands for extracorporeal membrane oxygenation. In simple terms, the ECMO treatment bypasses the function of the lungs. The patient’s blood is partially or completely freed from carbon dioxide outside the body and enriched with oxygen. The attending physician gains time to adjust the therapy according to the patient’s needs, and the lungs are relieved, giving them time to heal.

Xenios AG is a pioneer in extracorporeal heart and lung support. The Novalung and Medos products offer a wide range of heart and lung support products via a single platform, the Xenios console. Xenios’ mission is to improve patient well-being and care. The Novalung therapy aims at a paradigm shift in lung support: enabling the treatment of patients who are more awake, more self-determined and more mobile.

Xenios AG has been part of Fresenius Medical Care, the world’s leading provider of products and services for people with kidney disease since the end of 2016. Xenios complements the group’s portfolio in the area of holistic multi-organ support of Fresenius Medical Care.