Medtronic has obtained CE mark approval for its Stealth AXiS ENT Platform, enabling the surgical navigation system to be used for ear, nose and throat procedures throughout Europe. The certification broadens access for hospitals and clinicians to Medtronic’s latest navigation technology, which is intended to improve visualisation and support workflow efficiency during ENT interventions. Designed for both routine and highly complex sinus and skull base anatomy, the platform offers enhanced anatomical visualisation and faster system responsiveness than earlier generations, according to the company.
Commenting on the milestone, Medtronic ENT business president Sean Haag said: “Receiving the CE mark for the Stealth AXiS surgical system in ENT procedures is an important milestone for ENT surgeons and patients across Europe. “This platform builds on our long legacy in surgical navigation while introducing a more connected, intelligent system specifically designed for the future of ENT surgery.” The Stealth AXiS ENT Platform supports a range of procedures, including minimally invasive sinus surgery, skull base interventions and sinus balloon treatments. It is also integrated with Medtronic’s AiBLE ENT smart ecosystem, which links technologies and helps optimise workflow across ENT surgical settings.
Medtronic ENT business international vice-president Panos Drakoulas said: “We’re excited to reach this milestone and expand access to the Stealth AXi surgical system across Europe. “ENT surgeons are looking for technology that fits naturally into their workflow while helping them navigate basic to highly complex anatomy with confidence. “The Stealth AXiS surgical system was built with those insights in mind, and we look forward to supporting more surgeons and patients across the region.” The European approval follows US Food and Drug Administration (FDA) clearance for ENT applications earlier this year. The system has also received CE marking for spinal and cranial procedures. In May 2026, Medtronic also secured CE mark approval for its VitalFlow Transport Frame Air and Ground accessory, which is used with the VitalFlow extracorporeal membrane oxygenation system.