Personal Exoskeleton System Cleared by FDA for Home Use

Revolutionary technology that allows individuals with Spinal Cord Injury, such as paraplegia, to stand & walk receives clearance for personal use in the U.S.

Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community. ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk. ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

“This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries,” said Larry Jasinski, CEO of ReWalk Robotics. “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,” he added. “This is truly the beginning of ‘ReWalking’ as a daily reality in the U.S.”

ReWalk provides user-initiated mobility through the integration of a wearable brace support, a computer-based control system and motion sensors. The system allows independent, controlled walking while mimicking the natural gait patterns of the legs, similar to that of an able-bodied person. In addition to the ability to stand and walk independently, clinical studies of the ReWalk Rehabilitation system show significant health benefits to the user, on both a physiological and psychological level.

Study data of the ReWalk system indicates potential improvements in cardiovascular health, loss of fat tissue, building of lean muscle mass, and improved bowel function. Feedback from ReWalk users supports these potential benefits and others, such as better pain management, fewer medications, and potentially reduced hospitalizations.

ReWalk has been tested extensively in the U.S., Europe, and Israel. The ReWalk system is supported by the most published data of all exoskeleton systems in the rehabilitation market, and is used by more people worldwide than all other exoskeleton systems combined.

ReWalk was developed by Dr. Amit Goffer, an Israeli inventor who became quadriplegic after an ATV accident in 1997. It was through his own personal experience in utilizing mobility devices for people with spinal cord injury that Dr. Goffer developed the ReWalk.

“The person walks the system, the system does not walk them. The users are in control — when they want to sit, they sit, when then want to stand and walk, they do so,” said ReWalk inventor Dr. Goffer.

Reference: http://rewalk.com/news/press-release/rewalk-personal-exoskeleton-system-cleared-by-fda-for-home-use/