Medtronic secures CE mark approval for VitalFlow Extracorporeal Membrane Oxygenation (ECMO) System
Medtronic, a global leader in healthcare technology, has recently received CE Mark approval for its innovative VitalFlow Extracorporeal Membrane Oxygenation (ECMO) System in Europe. This system, designed to simplify ECMO therapy and expand access, is set to transform critical care across the continent.
The VitalFlow ECMO System is a significant advancement in Medtronic's mission to transform critical care, offering a user-friendly, adaptable design, and comprehensive support capabilities. The system is engineered to handle the increasingly complex diseases seen in critically ill patients, delivering reliable temporary heart and lung support that adapts to individual patient needs.
One of the key features of the VitalFlow ECMO System is its fully integrated and simple-to-use design. The system is intended to be operated by care teams with varying levels of experience, thanks to its intuitive interface. It also boasts a flexible configuration and upgradeable architecture, allowing it to meet evolving clinical demands over time without complete replacement.
The VitalFlow ECMO System builds on Medtronic's deep ECMO expertise, enhanced by the acquisition of MC3 Cardiopulmonary, which developed high-quality, differentiated ECMO products including catheters and oxygenators that simplify therapy and enhance ease of use.
The approval of the VitalFlow ECMO System reflects Medtronic's mission to restore health and extend life. Giuseppe Savoja, Western Europe senior business director for Medtronic's Cardiac Surgery business, stated that the CE Mark for the VitalFlow ECMO System is a significant step in Medtronic’s commitment to advancing critical care technologies that save lives and improve outcomes in critically ill patients.
The VitalFlow ECMO System is expected to simplify ICU operations, expand access to ECMO therapy, and support a wide range of patients, from adults to pediatrics. By reducing complexity in ECMO delivery, clinicians can focus more on patient outcomes rather than device management.
The acquisition of MC3 Cardiopulmonary by Medtronic marked the culmination of an eight-year partnership and distribution agreement. With the CE Mark for VitalFlow achieved in June 2025, Medtronic claims it is now poised to redefine ECMO care across Europe.
Pieter Kappetein, Ph.D., M.D., Chief Medical Officer at Medtronic's Cardiac Surgery division, noted that clinicians in the ECMO space have evolving needs, with a growing demand for innovative solutions like the VitalFlow ECMO system. This system is set to meet these needs, better serving patients in critical care settings across Europe.
The VitalFlow ECMO System, a product of Medtronic's acquisition of MC3 Cardiopulmonary, is a user-friendly and adaptable digital health solution, designed to address the evolving medical-conditions of critically ill patients. By simplifying ICU operations and delivering reliable temporary heart and lung support, the system aims to improve health-and-wellness outcomes in Europe.
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