Hengrui Medical Gains Approval for Groundbreaking Domestic ECMO Technology

Suzhou Hengrui Medical Device Co., Ltd. (Hengrui Medical) has received official approval from the National Medical Products Administration for its first domestically developed ECMO (extracorporeal cardiopulmonary support) system.

This marks a significant advancement in China’s independent research, development, and industrialisation of high-end medical devices, breaking the long-standing reliance on foreign technology in this sector.

ECMO is a vital extracorporeal life support technology used primarily for respiratory and circulatory support in critically ill patients. It plays a crucial role in treating severe conditions such as percutaneous coronary intervention (PCI), fulminant myocarditis, and acute respiratory distress syndrome.

Despite its increasing clinical demand, widespread adoption in domestic hospitals has been limited due to high costs and complex technical requirements.

The newly approved ECMO system from Hengrui Medical includes a host unit, circulation kit, arteriovenous cannula, warming device, and puncture kit. It incorporates advanced technologies such as full magnetic suspension drive and multi-modal control, ensuring high stability and reduced blood damage during operation.

Optimisation of the pump head structure and long-term anticoagulant coating technology further minimises blood damage, enhancing patient safety and treatment effectiveness.

The system is designed with a dual-host 1:1 configuration, where an emergency drive device serves as a backup to the main unit. This feature enhances operational reliability, and clinical trials have demonstrated its effectiveness and safety.

The trials met expected clinical outcomes without any device-related adverse events or defects, highlighting the system’s potential for clinical application.

This aims to strengthen its portfolio in critical care by advancing key products such as the interventional ventricular assist system (cVAD) and intra-aortic balloon pump system (IABP), offering patients more treatment options and improved medical services.