Medtronic receives FDA device clearance for Mazor platform devices


Medtronic has announced that the US Food and Drug Administration (FDA), has given clearance for the use of its navigated interbody and Midas Rex high speed drills with the Mazor Robotic Guidance System. According to Medtronic, this has come earlier than expected. 

Medtronic describes the Mazor platform as now providing surgeons with unprecedented procedural integration by combining the use of Midas Rex drills with the market leading visibility and navigation from the StealthStation software. 

Eiman Shafa, (Twin Cities Spine Center, Minneapolis, USA), 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.” He continues, “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.”

Medtronic states that it has evolved the Mazor platform to allow surgeons to quickly visualise anatomy and spinal structures in relation to one another in 3D, the enhanced interface delivers fast access to plan and simulate cages and screws, with the goal of increasing efficiencies for surgeons. 

Medtronic added the Midas Rex High Speed Drill Systems are now fully integrated throughout the Mazor procedure enabling improved trajectory precision starting with pilot hole creation and offering attachments and dissecting tools designed for accurate drilling with speeds up to 75,000 rpm. Additionally, surgeons can now utilise navigated interbody features on the Mazor system to visualise disc prep and interbody placement during a robotic procedure.


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