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The Food and Drug Administration has given approval for a company to sell its motorized exoskeleton device designed to help those who have become paralyzed.
Argo Medical Technologies of Marlborough, Mass. created the product, according to USA Today. The device, called “ReWalk,” provides hip and knee motion for those who have spinal cord injuries that have resulted in lower-body paralysis.
According to the FDA, ReWalk is meant for paraplegic people who have spinal cord injuries from T7 (seventh thoracic vertebra) to T5 (fifth thoracic vertebra). It is also meant for those with injuries in the T4 to T6 regions, but only for rehab purposes. The device is not meant for sports or for walking up stairs.
ReWalk is made of a metal brace that supports the legs and part of the upper body. It has motors that move the hips and knees for the person using the device. It can be operated with a wireless remote control that is intended to be worn on the wrist. Crutches are also used with the device to help stabilize the person using it.
"Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility," said Christy Foreman, the FDA director of device evaluation. "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."
The clearing of the product makes it possible to sell the device in the United States. The federal government estimates that there are around 200,000 people living in the U.S. with spinal cord injury.
Anyone wanting to purchase the product, along with their caregiver, must undergo a training in order to be able to use the product.
Larry Jasinski, CEO of Argo Medical Technologies says that the product is revolutionary. "For the first time, individuals with paraplegia will be able to take home this exoskeleton technology,'' he said.