Personal Exoskeleton Cleared by FDA for Home Use
New technology allows individuals with spinal cord injuries to stand & walk
The FDA has cleared ReWalk Robotics’ wearable robotic exoskeleton for use at home and in the community. The ReWalk Personal System provides powered hip and knee motion to enable individuals with spinal cord injury (SCI) to stand upright and walk.
The FDA issued marketing clearance for ReWalk after a de novo process that involved multiple clinical studies demonstrating safety and effectiveness of the technology. By taking the technology home, individuals with paraplegia will be able to maximize the physiological and psychological benefits observed in clinical trials.
U.S. Marine Corps Capt. Derek Herrera, a paraplegic trained on the ReWalk Personal System, will be one of the first owners. "It will be incredible for me to regain independence, to use the system to walk and stand on my own," he said.
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. Clinical studies of the ReWalk Rehabilitation system show significant health benefits to the user on a physiological and psychological level.
Study data of the ReWalk system indicate 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, and is used by more people worldwide than all other exoskeleton systems combined. It was developed by Dr. Amit Goffer, an Israeli inventor who became quadriplegic after an all-terrain vehicle accident in 1997.
The company offers two products. The ReWalk Personal System, designed for daily use at home and in the community, is custom-fitted to each individual and designed for daily use in a range of environments such as indoors and outdoors on different surfaces or terrains. The ReWalk Rehabilitation system is used in the clinical rehabilitation environment, where it provides a means of exercise and therapy as well as a training base for individuals to be certified, enabling them to purchase a Personal system.
"The person walks the system, the system does not walk them. The users are in control — when they want to sit, they sit, when they want to stand and walk, they do so," said Dr. Goffer.
The ReWalk Personal System is available to consumers who meet requirements from a medical examination and complete the required training program.
Source: ReWalk Robotics; June 27, 2014.