The expanded FDA approval enables the use of Atalante X self-balancing robotic exoskeleton beyond stroke rehabilitation for the rehabilitation of individuals with spinal cord injuries (SCI) at levels T5 to L5
Atalante X is the world's first self-balancing exoskeleton. (Credit: Wandercraft)
France-based medical robotic solutions provider Wandercraft has received expanded US Food and Drug Administration (FDA) approval for Atalante X, its self-balancing robotic exoskeleton.
Atalante X is the world’s first self-balancing, hands-free, multi-directional gait and balance exoskeleton that enables people with limited mobility to stand up and walk again.
The device leverages advanced self-stabilising technology to enable hands-free walking in patients with severe mobility impairments.
It is currently used in rehabilitation institutions and clinical research centres across the US, Europe, and Brazil.
In December 2022, Atalante X received FDA approval to treat cerebrovascular accident (CVA).
The current approval expands its previous indication to include rehabilitation in individuals with spinal cord injuries (SCI) at levels T5 to L5.
Wandercraft CEO Matthieu Masselin said: “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.
“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.”
The expanded FDA approval is supported by safety and effectiveness data of Atalante X in patients with SCI at levels T5-L5, evaluated in more than 500 patients.
Atalante X is the only FDA-approved exoskeleton with a powered ankle mechanism that can perform complex ankle movements that mimic a natural human gait.
Its unique ankle motion, together with intelligent self-balancing technology, enables patients to experience the benefits of walking once-again in a rehabilitation setting.
Kessler Foundation Centre for Mobility and Rehabilitation Engineering Research associate director and Tim and Caroline Reynolds Centre for Spinal Stimulation director Gail Forrest said: “The FDA clearance of Atalante X for spinal cord injury is welcome news for the future of robotics in rehabilitation research.
“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.”