Medtronic nets FDA clearance for robotic brain surgery guidance platform

head and brain
This year, Medtronic CEO Omar Ishrak described the company’s plans to bring robotics into “virtually every area” it has a procedural presence, with cranial procedures as a new starting point. (Image: American Heart Association)

Medtronic has received clearance from the FDA for a robotic guidance platform designed for navigating complex cranial surgeries—such as brain tissue biopsies, the placement of deep electrodes in patients suffering from seizures, or the positioning of bone anchors for subsequent, MRI-guided laser-ablation procedures.

The Stealth Autoguide system looks to create an end-to-end cranial robotics solution, by integrating with the company’s larger technology portfolio and its Surgical Synergy platform. It helps guide the spatial positioning and orientation of surgical instruments and tools in real-time, while also working to standardize procedures.

This includes connectivity with Medtronic’s StealthStation image guidance systems and the Midas Rex high-speed surgical drill. Stealth Autoguide also provides visualization and alignment feedback throughout the entire procedure, including while drilling.

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“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,” Medtronic’s Dave Anderson, vice president and general manager of enabling technologies, said in a statement.

RELATED: Medtronic takes its new surgery robot out for a spin with investor debut

This past August, Medtronic CEO Omar Ishrak described the company’s plans to bring robotics into “virtually every area” the medtech giant has a procedural presence. Cranial procedures, including tumor resection and lead and EEG placements, were specifically named as a new starting point—all following the company’s September 2018 acquisition of Mazor Robotics and subsequent launch of a new spine surgery system at the top of this year.

RELATED: Medtronic reveals past Karl Storz team-up ahead of robotic surgery unveiling

Since then, the company has also unveiled its modular soft-tissue surgical robot, the Hugo, in a practice demonstration for investors. Featuring multiple, cart-mounted arms, the system is being developed for a range of minimally invasive surgeries, including prostatectomy.

Medtronic is slating Hugo’s global launch and initial clinical data gathering to begin by the end of March 2020, with the goal of securing a CE mark and 510(k) clearance within two years.

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