Medtronic earned the FDA’s 510(k) clearance for its Stealth AXiS system that brings planning, navigation and robotics into one spine platform.
Stealth AXiS is cleared for use in spine surgery, and it is expected to support cranial and ENT pending additional clearance, according to a Feb. 13 news release. It is designed for use in hospitals and ASCs without relying on multiple standalone technologies.
The system features LiveAlign segmental tracking that lets surgeons visualize anatomic motion, surgical adjustments and patient alignment in real time during spine surgery. This eliminates the need for additional imaging.
“One of the biggest challenges in spine surgery has been understanding and responding to how the spine moves during a procedure,” Ronald Lehman, Jr., MD, spine surgeon and paid Medtronic consultant, said in the release. “The Stealth AXiS™ system gives surgeons real-time visibility into that motion, helping us more consistently achieve our surgical plan without interrupting workflow. To me, this is truly game changing technology.”
