Approximately 200,000 people in the US are now living with spinal cord injuries, many of which have left them paralyzed from the waist down and unable to walk. With luck, that number may be significantly reduced in the near future thanks to the FDA’s new decision to allow Argo Medical Technologies, Inc. to market ReWalk, the first motorized device worn over the legs and part of the upper body as an “exoskeleton” enabling individuals to sit, stand, and walk with assistance from a trained aide. The device is especially for individuals with paraplegia due to spinal cord injuries at levels T7 (7th thoracic vertebra) to L5 (5th lumbar vertebra), as well as for those with spinal cord injuries at levels T4 (4th thoracic vertebra) to T6 (6th thoracic vertebra) at rehabilitation institutions. It is not meant to be used by anyone with “a history of severe neurological injuries other than spinal cord injury, or have severe spasticity, significant contractures, unstable spine, unhealed limb fractures or pelvic fractures.”
In addition, the FDA states that patients “should also not use the device if they have severe concurrent medical diseases such as infection, circulatory conditions, heart or lung conditions, or pressure sores.”
The ReWalk device is made up of a fitted, metal brace that supports the legs and part of the upper body; and uses computerized motors held within a backpack to provide movement at the hips, knees, and ankles; along with a tilt sensor and power supply. “Commands” are provided through a wireless remote control worn on the wrist, which tells the device to allow the user to stand up, sit down or walk. In addition, additional patients are provided with crutches for additional stability when walking, standing, and rising up from a chair. It cannot, however,be used to climb stairs or for sports activities.
“Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility,” said Christy Foreman, director of the Office of Device Evaluation, at the FDA’s Center for Devices and Radiological Health. “Along with physical therapy, training and assistance from a caregiver, these individuals may be to use these devices to walk again in their homes and in their communities.”
For more information contact the FDA at 888 Info-FDA.