Medtronic Earns CE Mark for VitalFlow Transport Frame AG for ECMO

Medtronic has received CE mark approval for its VitalFlow Transport Frame Air and Ground (AG) as an accessory to its VitalFlow extracorporeal membrane oxygenation (ECMO) system.

The VitalFlow Transport Frame AG system will be officially launched at the EuroELSO Congress this week. It offers a stable, protected, and robust way to transport the entire VitalFlow ECMO system. Medtronic said the frame was rigorously tested and cleared for use in both ambulance and fixed aircrafts, including rotary and wing.

ECMO uses a pump and oxygenator outside of the body to take over the heart and lungs’ work to restore health and extend life to critically ill patients who may otherwise expire. It’s most often used for life-threatening heart of lung failure to allow the heart and/or lung to rest and heal. It’s also used as a bridge option to heart of lung transplantation or to further treatment like a heart assist device or left ventricular assist device (LVAD).

“When a patient is in critical condition and clinicians need to move quickly, every moment counts,” said Pieter Kappetein, Ph.D., MD, chief medical officer, Cardiac Surgery and Aortic, Medtronic. “By expanding access through transport, we’re helping to support the care of critically ill patients.”

The company said the EU milestone is a strong leap forward in providing seamless, critical support designed for inter-hospital transport, or transfer of patients between one or two more medical facilities. Previously, the VitalFlow Console and accessories for intrahospital use were approved in June 2025, transforming ECMO care across Europe with a configurable one- system solution.

The VitalFlow ECMO system launched in the U.S. in September 2024.