Medtronic’s Stealth AXiS surgical system has received FDA clearance. The system is meant to help surgeons plan spine procedures, navigate complex anatomy during surgery and guide instrument placement using integrated navigation and robotic support.
Spine surgery often requires surgeons to place implants, such as screws or rods, with high precision while accounting for complex anatomy and movement that can occur during a procedure. Surgical navigation systems are commonly used to map anatomy and guide instrument placement. Robotic systems can then help execute those plans with greater consistency.
In many cases, these tools operate separately. This can require workflow adjustments or repeated imaging to account for changes during surgery.
The Stealth AXiS system brings planning, navigation and robotic execution together within a single platform. By integrating these functions, the system can support a more continuous workflow during spine procedures. It also accommodates different surgical approaches, levels of complexity and care settings.
The Stealth AXiS surgical system is intended for use in both hospital operating rooms and ambulatory surgery centers. It is made to function without relying on multiple standalone navigation or robotic technologies.
One of the system’s key technical features is LiveAlign segmental tracking. This capability allows surgeons to see how different segments of the spine move and shift during surgery, instead of relying only on images captured at the beginning of the procedure.
As a spine operation progresses, patient positioning, surgical manipulation or implant placement can change spinal alignment. LiveAlign tracking is designed to update this information in real time. It shows alignment changes and surgical adjustments as they occur.
This approach reduces the need for repeated imaging and manual recalibration during the procedure.
The system uses a modular robotic design. This means hospitals and surgery centers can deploy specific components based on their current needs.
Institutions that already use navigation technology, for example, may add robotic functionality over time. This avoids the need to adopt a fully robotic setup at once. The approach is intended to allow flexibility as clinical programs and surgical volumes evolve.
The FDA clearance applies specifically to the system’s use in spine procedures. Its underlying architecture is designed to support potential future use in cranial and ear, nose and throat procedures, pending additional FDA review through the 510(k) pathway.
The Stealth AXiS system is also part of Medtronic’s AiBLE smart ecosystem. This ecosystem connects devices, software and data across different stages of surgical care.
Within this ecosystem, the Stealth AXiS platform integrates preoperative planning with intraoperative navigation and execution. This allows information to flow across the surgical process.
Related: Spine Innovation’s LOGIC Titanium Device Cleared for Use in Spinal Fusion
A few days after the Stealth AXiS clearance, Medtronic also reported the first US commercial surgical case using its recently FDA-cleared Hugo robotic-assisted surgery system. The procedure was performed in urology, marking the system’s initial clinical use in the US following regulatory clearance. The Hugo system is designed for robotic-assisted minimally invasive surgery and features a modular, mobile configuration that could support different operating room setups. Medtronic has indicated that the system is expected to expand into additional procedures, including gynecologic and general surgery applications.
Around the same time, VB Spine said it plans to acquire exclusive rights to the xvision Spine system from Augmedics. The xvision system is an FDA-cleared augmented reality-based navigation platform that can assist with precisely locating anatomical structures during spine procedures, including open, minimally invasive and percutaneous approaches. If completed, the transaction would add augmented reality navigation to VB Spine’s enhanced visualization portfolio.
In the Medtronic press release, Dr. Ronald Lehman, a spine surgeon at Columbia University and NewYork-Presbyterian/The Allen Hospital, highlighted spinal motion as a challenge in surgery.
Michael Carter, President of Medtronic’s Cranial and Spinal Technologies business, described the system as an effort to make advanced surgical technologies more practical for routine clinical use.
The Stealth AXiS surgical system is currently cleared for spine procedures in the US.
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