FDA allows marketing of first wearable walking device

The FDA has approved marketing of the first wearable, assisted walking device for people with spinal cord injuries. The device, ReWalk, acts as an exoskeleton by using a metal brace worn over the legs and upper body. It assist users in siting, standing and walking with support from a trained caregiver and an assistive standing device, which offer additional stability.

“Innovative devices such as ReWalk go a long way toward helping individuals with spinal cord injuries gain some mobility,” Christy Foreman, director of the Office of Device Evaluation at the FDA Center for Devices and Radiological Health stated in the FDA news release. “Along with physical therapy and training, individuals may be able to use these devices to walk again in their homes and communities.”

The device includes a tilt sensor, backpack that contains power supply and motors that provide movement at the hips, knees and ankles. It is controlled using a wireless remote control worn on the wrist.

ReWalk is for patients with paraplegia due to spinal cord injuries at levels T7 to L5 when accompanied by a specially trained caregiver. It is also for people with spinal cord injuries at levels T4 to T6 where the device is limited to use in rehabilitation institutions. The device is not intended for sports or climbing stairs.  Users must be able support crutches or a walker, and stand using their hands and shoulders. Users and caregivers must also undergo training to learn and demonstrate proper use of the device.

The FDA reviewed clinical and observational data to support use of the device on various walking surfaces and distances. It also reviewed safety systems should the device lose balance or power. Risks include pressure sores, bruising or abrasions, falls and associated injuries, and diastolic high blood pressure.

ReWalk is not intended for sports or climbing stairs, and patients should not use it if they have 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. Patients also should not use the device if they have severe concurrent medical diseases such as infection, circulatory conditions, heart or lung conditions or pressure sores.

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