FDA OKs Device to Help People With Some Spinal Injuries Walk

Larry Hand

Disclosures

June 26, 2014

The US Food and Drug Administration (FDA) has approved the marketing of the first wearable, motorized device to help people with paraplegia due to a spinal cord injury sit, stand, and walk with assistance from a companion, according to release by the FDA June 26.

The device, ReWalk (Argo Medical Technologies, Inc), consists of a fitted metal brace that supports the legs and part of the upper body, motors that supply movement to the hips, knees, and ankles, a tilt sensor, and a computer and power supply worn on the back. Crutches provide additional stability, and a wireless remote control commands the device to stand up, sit down, or walk.

It is intended for patients with spinal cord injuries at levels T7 to L5. It is also for people with spinal cord injuries at levels T4 to T6 when used only in rehabilitation institutions. The device is not intended for sports or climbing stairs.

To use the device, patients should be able to stand using an assistive .device with hands and shoulders able to support crutches or a walker. Patients with a history of severe neurological injuries, severe spasticity, significant contractures, an unstable spine, or unhealed limb or pelvic fractures should not use ReWalk. Also, patients with severe concurrent diseases such as infection, circulatory conditions, heart or lung diseases, or pressure sores, should not use the device.

Patients and caregivers are required to undergo extensive training before using the device.

The FDA approved the device after reviewing tests done to assess the device's durability, hardware, software, and battery systems, in addition to other safety systems that may minimize risk of injury.

Additional tests assessed trial participants' ability to walk various distances, the amount of time needed to walk those distances, and performances on various walking surfaces and slight slopes.

Risks associated with the device include pressure sores, bruising or abrasions, falls and associated injuries, and diastolic hypertension during use, according to the FDA.

“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, in an FDA news release. "Along with physical therapy, training and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities."

Argo Medical Technologies must complete a postmarket clinical study to collect data on adverse events and the effectiveness of its training program.

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