Irish medical technology company Medtronic has secured approval from the US Food and Drug Administration (FDA) for its Stealth Autoguide system, which is designed to be used in cranial procedures.

Stealth Autoguide is claimed to be the first cranial robotic platform, which integrates with Medtronic’s enabling technology portfolio to form an end-to-end procedural solution.

Medtronic’s Stealth Autoguide Platform is a robotic guidance system that is developed for spatial positioning and orientation of instrument holders or tool guides used in neurosurgical procedures.

Stealth Autoguide Platform can be used in biopsy procedures and stereoelectroencephalography (sEEG) depth electrode placement

Stealth Autoguide Platform secured approval for biopsy procedures, stereoelectroencephalography (sEEG) depth electrode placement, as well as for the positioning of the Visualase bone anchor that is used for catheter placement.

The solutions are part of Medtronic’s Surgical Synergy platform, which combines the company’s technologies to create consistent, predictable, and reproducible procedures.

Stealth Autoguide system incorporates with StealthStation Image Guidance systems and the Midas Rex high-speed surgical drill platform.

The navigation software enhances the surgical workflow to offer continuous real-time navigation and visual feedback on the robotic alignment for improved efficiency.

In addition, the system offers visualisation throughout the entire procedure, even while drilling. It holds the capacity to drill on the axis of a surgical plan.

Medtronic restorative therapies group’s enabling technologies general manager and vice president Dave Anderson 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.”

In November, Medtronic secured FDA approval for its IN.PACT AV drug-coated balloon (DCB) to treat arteriovenous (AV) fistula lesions.

IN.PACT AV DCB is a paclitaxel-coated balloon developed to treat failing AV access in patients with end-stage renal disease (ESRD) undergoing dialysis.