In an interaction with MedTech Spectrum, Giuseppe Savoja, Western Europe Senior Business Director for the Cardiac Surgery business at Medtronic, shared insights into the recent CE Mark approval of the VitalFlow™ ECMO System. Designed to address the critical needs of patients requiring extracorporeal life support, the system offers a compact, integrated platform with advanced sensors and real-time monitoring capabilities that enhance clinical precision and ease of use. Savoja highlighted that the VitalFlow system is a major step forward in improving patient care during cardiopulmonary emergencies, especially in intensive care and transport settings, and reflects Medtronic’s continued investment in innovation to support safer, more efficient critical care delivery across Europe.
With the CE Mark secured, what are Medtronic’s next steps for commercial rollout across European healthcare systems, and how will training and support be structured?
With the VitalFlow™ ECMO System CE (Conformité Européenne) Mark now secured, Medtronic is accelerating the rollout of the VitalFlow System to healthcare providers across Europe. The commercial launch is being conducted in close partnership with local clinical and marketing teams, with initial focus in the UK, Benelux, and Germany.
Recognizing that training and support are critical to successful adoption, Medtronic is deploying comprehensive onboarding programs tailored to the needs of both experienced ECMO centers and hospitals new to the field. This includes:
To ensure a smooth transition, field-based clinical specialists will also be available to provide on-site support.
What are the most significant clinical or operational advancements introduced with the VitalFlow™ ECMO System compared to previous ECMO technologies?
The VitalFlow Extracorporeal Membrane Oxygenation (ECMO) System is purposefully designed to elevate ECMO delivery. Understanding the complex and evolving demands of modern intensive care units, the VitalFlow design focuses on simplicity and performance. The system includes key innovation in the areas of user interface intuitiveness, versatile and flexible system configuration, durable design, and upgradeable architecture. This configurable, one solution, ECMO System is designed to enable ICU teams to operate the system with confidence and ease. This thoughtful design may help reduce the learning curve for healthcare providers.
The VitalFlow System integrates the Nautilus™ VF oxygenator and a centrifugal pump. When paired with Medtronic ECMO catheters — such as Bio-Medicus Life Support™, Crescent™ and Crescent™ RA Jugular Dual Lumen catheters — the system forms a unified, purpose-built ECMO circuit engineered for reliability and efficiency in critical care settings.
How does the VitalFlow System’s integrated and intuitive design support ICU teams in delivering more efficient and safer cardiopulmonary support, especially in high-acuity environments?
In high-acuity environments, the usability of ECMO systems may directly influence the quality of care. That is why the VitalFlow ECMO system is built with a user-centric interface designed to simplify operations, featuring streamlined controls, high-visibility alarms, and an intuitive layout that may support fast decision-making.
A key example of this is the VitalFlow ECMO System’s interface, which relies on symbols and numbers. This approach could minimize communication barriers across diverse teams, regardless of experience level or language background, enabling more consistent and confident patient support.
How does the VitalFlow System align with Medtronic’s long-term vision of improving access and standardization of ECMO therapy across both advanced and resource-limited clinical settings?
The VitalFlow ECMO System is an advancement in Medtronic’s mission to transform critical care. It was designed to address the most pressing challenges in critical care – accessibility and standardisation – across diverse healthcare environments.
Medtronic’s fully integrated approach to ECMO simplifies the complex delivery of this procedure by unifying all components – from oxygenator to pump to catheters – into a single, purpose-built eco-system. This may reduce variability in setup and operations, which could help hospitals establish consistent protocols and standardised workflows, regardless of their ECMO maturity level.
It is a milestone signaling a meaningful leap forward in delivering life-saving support to the most fragile patients. This launch supports Medtronic’s broader goal of advancing access to advanced life-saving support, ensuring that more patients can benefit from ECMO procedures when they need it most.
Can you elaborate on how Medtronic plans to evolve the VitalFlow platform further — particularly in terms of modularity, data integration, and scalability within the critical care ecosystem?
The VitalFlow ECMO System was designed as a platform for long-term innovation, making advanced ECMO procedure more accessible, adaptable, and smart. The system is built to be configurable and upgradeable, enabling adaptability as ECMO therapy and ICU demands evolve.
On the data integration front, the VitalFlow ECMO connectivity allows the transfer of real-time patient data to an external hospital system via the data streaming function. These capabilities are designed to support smart ICU workflows and may lay the foundation for AI-driven clinical decision support in the future.
With high performance, simplicity, and a configurable, upgradeable architecture, VitalFlow ECMO is more than a system – it is smart, scalable, and built to support the future of critical care.
Chaitrali Gajendragadkar
chaitrali.gajendragadkar@mmactiv.com
Senior Officer - Media Integrations
MedTech Spectrum
www.medtechspectrum.com
