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Devices FDA

 News Release - December 16, 2020

Medtronic Strengthens Leadership in Navigated, Robotic Spine Surgery with FDA Clearance of Midas Rex(TM) Drills and Navigated Disc Prep and Interbodies for U.S. with Mazor(TM) Robotic Guidance System

The First Company to Offer Navigated Interbody, Disc Prep and High-Speed Drills Launches a New Integrated Robotic Solution

Broader Functionality Includes Enhanced Visualization of Tools, Greater Access and Interbody Navigation to Streamline Hospital Workflows

DUBLIN, Dec. 16, 2020 -- (Healthcare Sales & Marketing Network) -- Medtronic plc (NYSE: MDT) announced that the U.S. Food and Drug Administration (FDA) has cleared the use of navigated interbody and Midas Rex™ high speed drills with the MAZOR™ Robotic Guidance System earlier than originally anticipated. The MAZOR™ platform now provides surgeons with unprecedented procedural integration by seamlessly combining the power of Midas Rex™ drills with the market leading visibility and navigation from the StealthStation™ software. 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.

"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."

Medtronic has evolved the MAZOR platform to allow 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 efficiencies for surgeons. The best-in-class, 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 utilize navigated interbody features on the MAZOR system to visualize disc prep and interbody placement during a robotic procedure.

"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, which is reported as part of the Restorative Therapies Group at Medtronic. "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."

About Medtronic

Medtronic plc (, headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

Source: Medtronic

Issuer of this News Release is solely responsible for its content.
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