Medtronic has announced that its VitalFlow extracorporeal membrane oxygenation (ECMO) system has officially received CE mark approval in Europe.
The VitalFlow ECMO technology joined the Medtronic portfolio following its acquisition of MC3 Cardiopulmonary, which closed in March 2024.
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.
“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, which is 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.”
“Clinicians in the ECMO space have evolving needs,” said Pieter Kappetein, chief medical officer, Cardiac Surgery, Medtronic. “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.”
