Medtronic’s new ECMO system receives a key approval
Medtronic has received CE mark approval for VitalFlow, its all-in-one extracorporeal membrane oxygenation (ECMO) system. The company first launched VitalFlow in September 2024, highlighting the importance of straightforward ECMO systems that are portable and easy to use.
ECMO systems help extend the lives of patients by taking over the function of the heart and/or lungs for a period of time. They can serve as a bridge to heart or lung transplant, for example, or offer temporary relief from severe heart failure symptoms.
The ECMO technology behind VitalFlow was developed by Michigan-based MC3 Cardiopulmonary, which Medtronic acquired in March 2024. Prior to the acquisition, MC3 Cardiopulmonary had been developing new ECMO devices that were exclusively sold and distributed by Medtronic. As part of that arrangement, Medtronic had an option to acquire MC3 Cardiopulmonary if certain milestones were met along the way.
VitalFlow was specifically created with the user experience in mind. According to Medtronic, common complaints about ECMO systems were used to guide the technology’s design and development.
The VitalFlow ECMO system. Image courtesy of Medtronic.
“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,” Giuseppe Savoja, Western Europe senior business director for Medtronic’s cardiac surgery business, said in a statement. “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,” added Pieter Kappetein, PhD, MD, chief medical officer of Medtronic’s cardiac surgery business. “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.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.