The FDA has allowed the ReWalk Personal System to be marketed, thus enabling individuals with lower-body paralysis resulting from a spinal cord injury to use the wearable, motorized exoskeleton at home.
The ReWalk Personal System consists of a fitted metal brace worn over the legs and part of the upper body. Motors incorporated into the system aid the movement of the hips, knees, and ankles. A computer and power supply are contained in a backpack. The user controls the system with a wireless remote control worn on the wrist. The system accommodates persons with heights between 5’3” and 6’3” and weights as great as 220 lb. Patients use crutches while wearing the ReWalk system.
“Innovative devices such as ReWalk go a long way toward 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 able to use these devices to walk again in their homes and in their communities.”
Patients with paraplegia due to spinal cord injuries between levels T7 and L5 can use the device when accompanied by a specially trained caregiver, according to the FDA. People with spinal cord injury between levels T4 and T6 also can use the device, but only in rehabilitation facilities, according to the FDA. The device is not intended for sports or climbing stairs.
Consumers and their caregivers must successfully complete a training program designed by ReWalk at a rehabilitation center or a VA hospital. Physicians evaluate the individual’s skill level based on training before writing a prescription for the device.
Before being trained to use ReWalk, patients should be able to stand using an assistive standing device (eg, standing frame), and their hands and shoulders should be able to support crutches or a walker, according to the FDA. Patients should not use the device if they have a history of severe neurologic injuries other than spinal cord injury or if they have severe spasticity, significant contractures, unstable spine, unhealed limb fractures, or pelvic fractures. In addition, patients should not use the device if they have severe concurrent medical diseases such as infection, circulatory conditions, heart or lung conditions, or pressure sores.
“The person walks the system. The system does not walk them,” said Amit Goffer, PhD, Founder, President, and Chief Technical Officer of ReWalk Robotics. “The users are in control. When they want to sit, they sit. When they want to stand and walk, they do so.”
Data suggest that the ReWalk system may improve cardiovascular health, slow the loss of fat tissue, build lean muscle mass, and improve bowel function, according to the company. The system also may aid pain management, reduce the number of medications, and reduce hospitalizations.