Medtronic has received the CE mark for its Stealth AXiS surgical system, clearing the way for its use in ear, nose, and throat (ENT) procedures across Europe.
The certification gives hospitals and surgeons in the region wider access to Medtronic’s latest navigation platform, designed to enhance visualisation and streamline workflow during ENT surgeries.
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The Stealth AXiS system is designed to assist surgeons in navigating both basic and complex sinus and skull base anatomies.
According to Medtronic, the new platform offers improved anatomical visualisation and quicker system response compared to previous generations.
The system aims to support efficiency and confidence for surgeons by streamlining workflows in the operating theatre.
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 device is compatible with a variety of ENT interventions, including minimally invasive sinus and skull base operations, as well as sinus balloon procedures.
It integrates with Medtronic’s AiBLE ENT smart ecosystem, which connects technologies and optimises workflow across a wide range of ENT surgical procedures.
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 CE mark follows similar clearance by the US Food and Drug Administration (FDA) for ENT applications earlier in the year. The Stealth AXiS system has also been CE-marked for spinal and cranial procedures.
Last month, Medtronic received the CE mark for its VitalFlow Transport Frame Air and Ground, which functions as an accessory to the VitalFlow extracorporeal membrane oxygenation system.
