Medtronic cranial robotic platform receives FDA clearance

The Food and Drug Administration (FDA) has cleared a cranial robotic platform that integrates with Medtronic technology to create an end-to-end procedural system.

The Stealth Autoguide Platform is a robotic guidance system intended for the spatial positioning and orientation of instrument holders or tool guides used in neurosurgical procedures.

The platform is cleared for biopsy procedures, stereo electroencephalography (sEEG) depth electrode placement, and for the positioning of the Visualase bone anchor, which is used for catheter placement. These solutions are part of its Surgical Synergy platform, which integrates Medtronic technologies to create procedures.

P. David Adelson, division chief of Neurosurgery and director of Barrow Neurological Institute at Phoenix Children’s Hospital, said: "Medtronic continues to deliver on its commitment of developing innovative technologies that helps physicians seamlessly provide high-quality care for cranial and other procedures. The precision provided by the Stealth Autoguide system will help my clinical team accomplish unique surgical scenarios with increased accuracy.”

Stealth Autoguide system integrates with StealthStation Image Guidance systems and the Midas Rex surgical drill platform. The navigation software optimises the surgical workflow, providing real-time navigation and visual feedback on the robotic alignment. The system provides visualisation throughout the entire procedure, even while drilling, with the ability to drill on the axis of a surgical plan.

Dave Anderson, vice president and general manager, Enabling Technologies, part of the Restorative Therapies Group at Medtronic, said: “The Stealth Autoguide Platform provides surgeons and operating room staff with robotic-assisted positioning and trajectory guidance for cranial procedures confirming consistent, repeatable, and accurate alignment to their surgical plans. The Stealth Autoguide Platform showcases Medtronic’s commitment to advancing care and delivering the best outcomes to the most patients possible through our Surgical Synergy platform.”