Approval expands access to the company’s next-generation ear, nose and throat (ENT) navigation platform across Europe. It offers advanced visualization, navigation and connected workflow capabilities to ENT surgeons and hospitals.
Stealth AXiS combines familiar navigation workflows with a modular robotic design, the medtech giant says. It allows institutions to deploy what they need and expand over time as needs evolve. The company built the system on its existing Mazor and StealthStation technologies.
Medtronic built its system to support a range of surgeon preferences, clinical complexity and care settings. It designed Stealth AXiS for use across hospitals and the increasingly popular ambulatory surgery centers (ASCs). The system can operate in these settings without relying on multiple standalone technologies.
The platform brings planning, navigation and robotics together into a single, intelligent system. Michael Carter, SVP and president of Medtronic Cranial & Spinal Technologies, spoke to MassDevice earlier this year to outline the benefits of the system.
In ENT, the platform supports a broad range of procedures, including minimally invasive sinus and skull base surgery, plus sinus balloon procedures. It integrates into the company’s AiBLE ENT smart ecosystem as well. Medtronic recently inked a collaboration with Karl Storz to boost these efforts.
The latest CE mark follows a series of regulatory nods for Stealth AXiS, including from the FDA for spine procedures in February, then for ENT surgery in March. Its first CE mark approval for spine and cranial procedures came in April.
Commentary from Medtronic officials
Sean Haag, president of the ENT business at Medtronic, said:
“Receiving 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.”
Panos Drakoulas, VP of international for Medtronic ENT, added:
“We’re excited to reach this milestone and expand access to the Stealth AXiS 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.”
