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ReWalk exoskeleton for spinal cord injury people gets cleared by FDA

U.S. President Barack Obama greets Theresa Hannigan from New York, who is wearing a ReWalk bionic walking assistance system, at an Israeli technology exhibition at the Israel Museum, in Jerusalem, Israel.
U.S. President Barack Obama greets Theresa Hannigan from New York, who is wearing a ReWalk bionic walking assistance system, at an Israeli technology exhibition at the Israel Museum, in Jerusalem, Israel.
Photo by Debbie Hill-Pool/Getty Images

An exoskeleton for spinal cord injury people gets U.S. Food and Drug Administration (FDA) clearance to market use at home and communities. People with spinal cord injuries or lower body paralysis known as paraplegia can get help with mobility from the innovative device, ReWalk, made by ReWalk Robotics, formerly Argo Medical Technologies, Inc., in Marlborough, Massachusetts. The FDA cleared marketing of this revolutionary personal exoskeleton system that allows people with spinal cord injuries to stand and walk.

Exoskeleton for spinal cord injury granted by FDA

The FDA tested ReWalk’s battery systems, safety devices, software, hardware, and durability to minimize the risk of injury due to loss of power or balance. Furthermore, the FDA reviewed study data of 30 participants. Observational data of 16 patients supported the use of this exoskeleton device on a variety of walking surfaces, distances, performance on slight slopes, and time it took to walk a range of distances in the community and home. During the use of ReWalk, patients experience side effects, such as diastolic hypertension, abrasions or bruising, some falls and pressure sores.

Christy Foreman, director of the Office of Device Evaluation, at the FDA’s Center for Devices and Radiological Health explained the following about ReWalk, “Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility. 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. ”

Larry Jasinski, CEO of ReWalk Robotics added, “This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries. For the first time individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and maximize on the physiological and psychological benefits we have observed in clinical trials. This is truly the beginning of ‘ReWalking’ as a daily reality in the U.S.”

Using the ReWalk exoskeleton

An Israeli inventor by the name of Dr. Amit Goffer developed ReWalk resulting from his own personal experience in using mobility devices after becoming quadriplegic after a 1997 ATV accident.

ReWalk’s Chairman of the Board, Jeff Dykan said the following, “ReWalking is much more than walking. ReWalk provides paralyzed individuals with the ability to stand and walk, to look someone in the eye, to hug and be hugged. These are simple acts, which many of our ReWalkers thought they would never be able to do again. When you take that into account in addition to the health benefits, it underscores just how monumental a day this is for the SCI community here in the U.S.”

The user initiates mobility using the ReWalk system. Motion sensors, a computer based control system, and a wearable brace support that supports part of the upper body and legs allows the user independent control of walking and provides them the capability to stand. Currently, ReWalk’s exoskeleton system is used worldwide.

According to the FDA, June 26, 2014 news release, the ReWalk device is not for use in climbing stairs or sports. ReWalk is most beneficial when patients with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra) are accompanied by a specially trained caregiver. In addition, for individuals with spinal cord injuries at levels T4 (fourth thoracic vertebra) to T6 (sixth thoracic vertebra) the device is limited and used primarily in rehabilitation institutions.

U.S. Marine Corps Captain, Derek Herrera will be one of the first Americans to own the ReWalk. Derek works for the Marine Special Operations Command and is a paraplegic trained on the ReWalk Personal System. The Marine Special Operations Command Foundation will be donating the funds for Herrera’s ReWalk system.

The ReWalk System is available to consumers who meet certain requirements, such as completing a training program successfully and a medical examination.