Deans' stroke musings: Wandercraft's self-balancing exoskeleton receives second FDA clearance in less than a year, now indicated for rehabilitation in patients with spinal cord injury

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Tuesday, February 13, 2024

Wandercraft's self-balancing exoskeleton receives second FDA clearance in less than a year, now indicated for rehabilitation in patients with spinal cord injury

Isn't your competent? doctor already using this for stroke patients? But I guess you don't have a functioning stroke doctor, do you?

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 clinical¹ 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.”