Israeli entrepreneur Amit Goffer came up with the design of the ReWalk, a wearable robotic exoskeleton that allows paraplegics to walk, when he was looking for an alternative to a wheelchair when he became quadriplegic in 1997.
Goffer's device, which was originally intended for his own mobility, however, will soon become available to thousands of Americans with spinal cord injury and paraplegia as it finally received the green light to be marketed in the U.S. On Thursday, the Food and Drug Administration (FDA) announced that it has cleared the marketing of the ReWalk.
"The U.S. Food and Drug Administration today allowed marketing of the first motorized device intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a spinal cord injury," the FDA said in a statement.
ReWalk has motion sensors, a computer-based control system that is carried in a backpack and a wearable brace support. The motorized device allows paraplegics to sit, stand and walk accommodated by a trained caregiver.
"The person walks the system, the system does not walk them," Goffer described the system. "The users are in control - when they want to sit, they sit, when then want to stand and walk, they do so."
Clinical studies show that besides allowing paraplegics to walk, ReWalk, which was launched in 2012 and manufactured by Argo Medical Technologies Inc., the company founded by Goffer in 2011, also has a positive impact on health with users experiencing improvements in their cardiovascular health and bowel function as well as loss of fat tissue.
The FDA, however, noted that there are several risks associated with the use of the device including pressure sores, bruising, falls and similar injuries, and diastolic blood pressure during use. It also warned that the device should not be used for sports or for climbing stairs.
A version of the ReWalk, the ReWalk Rehabilitation, is already widely used in rehabilitation centers in the U.S but the system that was green-lighted by the FDA, the Rewalk Personal System, is intended for use in homes and communities.
ReWalk's manufacturer, Argo Medical Technologies, said that the system will be made available to patients who meet medical requirements and successfully complete a training program. The system will cost $69,500.
Of the estimated 200,000 individuals in the U.S. who have spinal cord injury, a large percentage either have partial or complete paralysis of the legs and lower body.
