Medtronic plc announced that it has received a CE Mark for the VitalFlow™ Transport Frame Air and Ground (AG) accessory to its VitalFlow Extracorporeal Membrane Oxygenation (ECMO) System in Europe. The approval, granted on May 5 2026, authorizes the product to be sold throughout the European Economic Area and represents the first regulatory approval for this accessory in the region.
The VitalFlow system itself entered the U.S. market in September 2024 and received CE Mark approval for intrahospital use in June 2025. The transport frame accessory, designed for ambulance and fixed‑aircraft use, completes the Medtronic ECMO solution, allowing care teams to move patients safely between operating rooms, intensive care units and transport teams without compromising support. The acquisition of MC3 Cardiopulmonary in March 2024 provided the technology that underpins the VitalFlow platform, positioning Medtronic as a key player in the growing ECMO market.
By adding a dedicated transport frame, Medtronic offers a more complete critical‑care solution that can drive higher adoption and utilization of its ECMO systems in European hospitals. The CE Mark opens a new revenue stream in a market projected to grow from USD 0.62 billion in 2024 to USD 0.86 billion by 2030, a CAGR of 5.8%. Medtronic currently ranks second in global ECMO market share behind Getinge, and the transport capability strengthens its competitive position against rivals such as Abbott, Terumo and Fresenius Medical Care.
Management highlighted the strategic importance of the approval. Giuseppe Savoja, Western Europe senior business director for Cardiac Surgery, said the VitalFlow ECMO System 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.” Chief medical officer Pieter Kappetein added that expanding access through transport “supports the care of critically ill patients.”
The CE Mark process required Medtronic to demonstrate compliance with the Medical Device Regulation (MDR), including safety, performance and quality requirements. The manufacturer’s declaration of conformity, completed after rigorous testing for ambulance and aircraft use, confirms that the transport frame meets the essential requirements for medical devices in the European Economic Area. The approval is a key regulatory milestone that enables Medtricipon to commercialize the accessory across all EU member states.
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