Medtronic has announced what it says is a major advancement in its mission to transform critical care, the VitalFlow Extracorporeal Membrane Oxygenation (ECMO) System has officially received CE (Conformité Européenne) Mark approval in Europe.
The company says this milestone signals a ‘significant leap forward’ in delivering seamless, life-saving support to the most fragile patients. With the CE Mark secured, Medtronic now offers a ‘simple, fully integrated’ ECMO portfolio in Europe, which it says is purpose-built to meet the complex and evolving demands of modern intensive care units.
Medtronic says the VitalFlow ECMO technology is the most innovative technology to-date from its acquisition of MC3 Cardiopulmonary, originally founded in 1991 by Dr. Robert Bartlett. The acquisition marked the culmination of an eight-year partnership and distribution agreement with the Medtronic Cardiac Surgery business resulting in the introduction of seven new ECMO products in seven years.
MC3 Cardiopulmonary developed and manufactured differentiated, high-quality ECMO products, which were exclusively distributed by Medtronic prior to the acquisition. These products, including catheters and oxygenators, are distinguished by their ability to simplify therapy and enhance ease of use says the company.
Additionally, the partnership has reliably supplied these long-term indicated products throughout the COVID pandemic and beyond. With the CE Mark for VitalFlow achieved June 2025, Medtronic claims it is now “poised to redefine ECMO care across Europe.”
“The CE Mark for the VitalFlow ECMO System is a powerful reflection of how we bring the Medtronic Mission to life — by engineering technologies that restore health and extend life,” said Giuseppe Savoja, Western Europe senior business director for the Cardiac Surgery business, part of the Cardiovascular Portfolio at Medtronic. “VitalFlow ECMO is more than a system; it’s a step toward transforming how ECMO is delivered across Europe. By simplifying complexity and expanding access, we’re helping care teams focus on what matters most – saving lives and improving outcomes for critically ill patients.”
Pieter Kappetein, Ph.D., M.D., Chief Medical Officer, Cardiac Surgery, Medtronic said: “Clinicians in the ECMO space have evolving needs. With patients’ diseases becoming more complex, there is a growing demand for innovative solutions such as the VitalFlow ECMO system. Clinicians expect more from Medtronic and we are uniquely positioned to meet these needs to better serve their patients.”
