Wandercraft's self-balancing exoskeleton receives second FDA clearance in less than a year, now indicated for rehabilitation in patients with spinal cord injury
Wandercraft's self-balancing exoskeleton receives second FDA clearance in less than a year, now indicated for rehabilitation in patients with spinal cord injury
· This marks Wandercraft’s second FDA clearance for Atalante X, the world’s first self-balancing exoskeleton, following clearance for stroke rehabilitation in December 2022
· FDA clearance paves the way for Wandercraft to positively impact more patients with walking impairments
· News comes just after Wandercraft unveiled its Personal Exoskeleton, the first and only self-balancing exoskeleton designed for personal everyday use
*NEW YORK **– 13 February** 2024* -- Wandercraft, the developer of the world's first self-balancing robotic exoskeleton that enables people with limited mobility to stand up and walk again, announced today that it has received FDA clearance for Atalante X for rehabilitation in individuals with spinal cord injuries (SCI) at levels T5 to L5.
Today’s clearance is supported by safety and effectiveness data of Atalante X in patients with SCI at levels T5-L5 and has been evaluated in more than 500 patients, including clinical^1 trials and real-world evidence.
The FDA’s previous clearance of Atalante X for cerebrovascular accident (CVA) in December 2022, combined with the recent unveiling of their Personal Exoskeleton designed to one day replace the wheelchair, further validates the potential of Wandercraft’s technology and their momentum as a growing force in the global medical device market.
*Matthieu Masselin, CEO of Wandercraft, commented*, “Today’s 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.”
Atalante X is the only FDA cleared exoskeleton with a powered ankle mechanism that can perform complex ankle movements that mimic a natural human gait. The unique ankle motion, combined with intelligent self-balancing technology, means that patients can experience the benefits of once-again walking in a rehabilitation setting.
Wandercraft’s approach means that therapists can now help even more patients:
· stand up and walk in the exoskeleton, on their very first session
· take steps in different directions (e.g., forwards, backwards, sideways)
· practice standing in an upright and weight-bearing positions
· more easily transfer in and out of the device
“The FDA clearance of Atalante X for spinal cord injury is welcome news for the future of robotics in rehabilitation research,” said Gail Forrest, PhD, 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. “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.”
The team behind Wandercraft believes everyone should have the opportunity to stand-up and walk in their everyday lives. Wandercraft looks forward to continued testing, clinical trials, and working with regulators to bring the benefits of robotics to the rehabilitation and personal use market.
Masselin added, “Today represents a decade of hard work and I am so proud of the entire Wandercraft team. What was once a dream of helping people walk again is becoming a reality as we relentlessly pursue our mission of supporting people with walking impairments through every step of their mobility journey.”
*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
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*About Atalante X*
Atalante X is the world's first self-balancing, hands-free, multi-directional gait and balance exoskeleton, creating new possibilities to plan dynamic treatment sessions with patients. It enables hands-free walking in patients with severe mobility impairments by using innovative self-stabilizing technology, allowing them to rediscover their natural height, freedom of movement, and improved health. It is currently in use in rehabilitation institutions and clinical research centers across the United States, Europe, and Brazil.
*About Wandercraft*
Wandercraft is a global manufacturer developing and commercializing advanced robotic solutions to enable people with walking impairments to stand up and walk again. The Company has used its engineering expertise to design Atalante X, the world's first self-balancing walking exoskeleton which emulates human walking and provides hands-free multi-directional locomotion. Atalante X is already used by many hospitals and healthcare facilities in Europe and the USA. Several different walking programs are designed to support rehabilitation and greater independence.
For more information, please visit https://en.wandercraft.eu/#hero-demo.
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*Media contacts*
*Wandercraft *
Lilly Kofler
Global Head of Marketing & Communications
lilly.kofler@wandercraft.health
*ICR Consilium (for Wandercraft)*
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