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Home » Medtronic wins CE mark for VitalFlow ECMO system

Medtronic wins CE mark for VitalFlow ECMO system

June 9, 2025 By Sean Whooley

This is an image from Medtronic of its VitalFlow extracorporeal membrane oxygenation (ECMO) system.
The VitalFlow extracorporeal membrane oxygenation (ECMO) system [Image courtesy of Medtronic]

A Medtronic  (NYSE: MDT) official announced on social media that the company received CE mark for its VitalFlow system within its Cardiac Surgery portfolio.

Giuseppe Savoja, the medtech giant’s senior business director for Western Europe, posted the announcement on LinkedIn:

“Big news from Medtronic Cardiac Surgery in Europe!” Savoja wrote. “It is with immense excitement that I share a landmark achievement in our journey to advance ECMO patient care: The VitalFlow system is now officially CE marked!”

The VitalFlow extracorporeal membrane oxygenation (ECMO) system provides temporary support for the heart and lungs. It works by circulating a patient’s blood outside the body through a specialized machine. ECMO adds oxygen and removes carbon dioxide, essentially taking over the functions of the heart and lungs.

Medtronic touts VitalFlow as a configurable one-system ECMO system designed to provide simplicity and performance. It bridges the gap between bedside care and intra-hospital transport. The medtech giant acquired the technology by purchasing MC3 Cardiopulmonary in March 2024. It formally launched VitalFlow last fall.

Savoja said on LinkedIn that the company aims to make ECMO smarter, simpler and more accessible with its latest regulatory nod.

“This is more than a regulatory milestone — after years of pioneering ECMO innovation, we are now taking the next bold step in closing the tip-to-tip loop of care for the most fragile patients in our region,” he wrote.

Filed Under: Blood Management, Cardiovascular, Regulatory/Compliance, Respiratory Tagged With: Medtronic

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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