Wandercraft, the developer of the world’s first self-balancing robotic exoskeleton has received FDA clearance for Atalante X.
 
This clearance supports the safety and effectiveness data of Atalante X for rehabilitation in patients with spinal cord injuries (SCI) levels T5 to L5. It has been evaluated in more than 500 patients including clinical trials₁ and real-world evidence.
 
CEO Matthieu Masselin commented: “[This] FDA clearance for individuals with spinal cord injuries speaks volumes about the amazing possibilities for Atalante X. In addition to the successful unveiling of our Personal Exoskeleton in December, Wandercraft has achieved several key milestones over the last year, and we have no plans of slowing down.”
 
Wandercraft’s previous FDA clearance for Atalante X was received in December 2022 for cerebrovascular accident (CVA). Combined with the company’s Personal Exoskeleton, it was designed to one day replace wheelchairs. Wandercraft’s self-balancing robotic exoskeleton provides people with limited mobility the ability to stand and walk. 
 
Atalante X is the only FDA-cleared exoskeleton with a powered ankle mechanism that mimics a natural gait. It performs unique and complex ankle movements that are combined with intelligent self-balancing technology so that patients can experience walking in a rehabilitation setting.
 
“The FDA clearance of Atalante X for spinal cord injury is welcome news for the future of robotics in rehabilitation research,” said Gail Forrest, director of the Tim and Caroline Reynolds Center for Spinal Stimulation and associate director of the Center for Mobility and Rehabilitation Engineering Research at Kessler Foundation.
 
The Atalante X allows patients to stand up and walk in the exoskeleton on the first session, practice weight-bearing positions, and take steps in multiple directions, while easily transferring in and out of the device. 
 
“At Kessler, we are committed to researching promising advances in robotics technology that offer innovative approaches to improving functional recovery. This new indication greatly expands our opportunities to study the optimal use of this innovative exoskeleton in this population with challenging mobility deficits. The insights we are gaining from our investigation of Atalante X are not only advancing our research in spinal cord injury but also enriching our understanding of neuro/functional recovery across other populations as well,” Forrest added.
 
Wandercraft will continue to hold testing and clinical trials while working with regulators to bring Atalante X to the rehabilitation and personal use markets. 
 

References:
 
1.Kerdraon, J., Previnaire, J.G., Tucker, M. et al. Evaluation of safety and performance of the self balancing walking system Atalante in patients with complete motor spinal cord injury. Spinal Cord Ser Cases 7, 71 (2021). https://doi.org/10.1038/s41394-021-00432-3