FDA Clearances Enhance Mazor™ Robotic Guidance System

Medtronic tells us that the U.S. FDA has cleared the use of navigated interbody and Midas Rex™ high speed drills with the Mazor™ Robotic Guidance System earlier than originally anticipated.


Medtronic’s Mazor platform allows surgeons to quickly visualize anatomy and spinal structures in relation to one another in 3D. The enhanced interface delivers fast and seamless access to plan and simulate cages and screws, with the goal of increasing efficiency.

By combining the power of Midas Rex™ drills with the market leading visibility and navigation from the StealthStation™ software, Medtronic says the platform now provides surgeons with unprecedented procedural integration. The solution delivers the confidence of access and interbody navigation and predictability of planning, along with the precision of robotic technology that surgeons expect from the Mazor™ Robotic Guidance System and the exclusive Medtronic robotics portfolio.

The Midas Rex High Speed Drill Systems are now fully integrated throughout the Mazor procedure. This enables improved trajectory precision starting with pilot hole creation. It also offers attachments and dissecting tools designed for accurate drilling with speeds up to 75,000 rpm. Additionally, surgeons can now utilize navigated  interbody features on the Mazor system to visualize disc prep and interbody placement during a robotic procedure.

Clinician comments

“Operating rooms are very complex environments, and we look forward to incorporating new functionality into our Mazor workflow to enhance the predictability and precision of a broader range of procedures leading to better patient outcomes,” said Dr. Eiman Shafa of Twin Cities Spine Center. “The ability to broaden surgical staff awareness about the procedure plan and potentially reduce fluoroscopy radiation should also improve our workflow creating a win-win for all hospital stakeholders.”

Company comments

“Transforming spinal care is a top priority for Medtronic and we work closely with customers to develop products that anticipate their needs,” said Linnea Burman, vice president & general manager, enabling technologies: cranial & spinal technologies

“With these recent clearances, we have advanced the Mazor platform by increasing its utility, improving its precision and adding capabilities as we drive toward our goal of delivering value-driven solutions for unmet needs.”

Source: PR Newswire

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