VitalFlow™ ECMO System Earns CE Mark, Strengthening Medtronic’s Cardiac Portfolio

The CE Mark approval of the VitalFlow™ ECMO System marks a significant advancement in extracorporeal life support, delivering enhanced precision and control for managing critically ill cardiac and respiratory patients.

In an interaction with MedTech Spectrum, Giuseppe SavojaWestern Europe Senior Business Director for the Cardiac Surgery business at Medtronic, shared insights into the recent CE Mark approval of the VitalFlow™ ECMO System. Designed to address the critical needs of patients requiring extracorporeal life support, the system offers a compact, integrated platform with advanced sensors and real-time monitoring capabilities that enhance clinical precision and ease of use. Savoja highlighted that the VitalFlow system is a major step forward in improving patient care during cardiopulmonary emergencies, especially in intensive care and transport settings, and reflects Medtronic’s continued investment in innovation to support safer, more efficient critical care delivery across Europe.

With the CE Mark secured, what are Medtronic’s next steps for commercial rollout across European healthcare systems, and how will training and support be structured?

With the VitalFlow™ ECMO System CE (Conformité Européenne) Mark now secured, Medtronic is accelerating the rollout of the VitalFlow System to healthcare providers across Europe. The commercial launch is being conducted in close partnership with local clinical and marketing teams, with initial focus in  the UK, Benelux, and Germany.

Recognizing that training and support are critical to successful adoption, Medtronic is deploying comprehensive onboarding programs tailored to the needs of both experienced ECMO centers and hospitals new to the field. This includes:

  • Hands-on training using high-fidelity simulators 
  • In-person workshop sessions for practical, scenario-based learning
  • Opportunities to connect with clinicians experienced with the VitalFlow ECMO System 

To ensure a smooth transition, field-based clinical specialists will also be available to provide on-site support

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