FDA OK’s Israeli system to help the paralyzed walk

ReWalk, the Israeli-developed exoskeleton system that enables the paralyzed to walk, has been cleared for home use by the FDA, a key step toward supplying the device that has shown it can revolutionize the lives of war casualties and others who have lost the use of their legs.

Via computers and motion sensors, ReWalk controls movement using subtle changes in center of gravity, mimics natural gait and provides functional walking speed, enabling even paraplegics to move independently. They can even run marathons, as a paralyzed woman did in 2012. ReWalk allows independent, controlled walking similar to that of an able-bodied person. A forward tilt of the upper body triggers the first step and gets the system going. Once the wearer is in motion, the system continues to “walk” while the body or head move forward, in the same manner as an able-bodied person. There are several other exoskeleton systems in development, by ReWalk is the first to receive approval from the FDA, the US government agency that vets medicines and medical devices and allows them on the market.

While FDA approval is a vitally important step in the process, it does not lead to immediate marketing.

No date for that was given, and a price has not been established. The system has been extensively studied and tested in Israel, the US, and Europe. It is already in use by people around the world who participated in ReWalks’ beta program.

Clinical studies show that in addition to providing wearers with the ability to stand and walk independently,  using the ReWalk provides significant mental health benefits, as users have a more positive self-image as they gain independence and control over their movements. Besides this, the studies show, using ReWalk promotes cardiovascular health, loss of fat tissue, building of lean muscle mass, and improved bowel function. ReWalk users report that since they began using the system, they have less pain, take fewer medications, and are in the hospital less often.

One of the first Americans to own the ReWalk will be Marine Corps Captain Derek Herrera, who has been “practicing” on the system since 2012. Herrera was paralyzed as a result of injuries he suffered in Afghanistan in 2012. “I see this as a milestone for people in my same situation who will now have access to this technology — to experience walking again, and all of the health benefits that come with ReWalking,” Herrera said. “It will be incredible for me to regain independence, to use the system to walk and stand on my own.”

Not even a marathon is out of reach for ReWalk users. In 2012, Claire Lomas, paralyzed from the chest down, completed the marathon course at the London Paralympics. It took her 17 days — but considering that she hadn’t been able to walk for five years due to injuries from a horse riding accident, completing the course — or even starting it — was a big deal for her. “The London Marathon was a huge ambition,” Lomas said. “It’s not what the people from ReWalk were expecting. It is one thing walking around the room but quite another to walk 26 miles after 12 weeks’ training. I never questioned I would not do it. I just took every step and every step was a step closer.”

The company offers two products — ReWalk Personal and the ReWalk Rehabilitation wearable robotic systems. The ReWalk Personal System, designed for everyday use by individuals at home and in their communities, is custom-fit for each user. The system is designed for daily use in a range of environments such as in the home, at work, at social events, indoors as well as outdoors, as well as on different surfaces or terrains. The technology allows users to stand, turn and walk with independent control of the system. The ReWalk Rehabilitation system is used in the clinical environment, a “general-fit” system that allows users to train to use the Personal system. US President Barack Obama personally reviewed ReWalk last year during his visit to Israel.

The system was part of a special exhibition called “Israeli Technology For a Better World” at the Israel Museum, highlighting seven of Israel’s most important tech contributions. The system was developed by Dr. Amit Goffer, an Israeli inventor who became a quadriplegic after an ATV accident in 1997. Through his own personal experience in utilizing mobility devices for people with spinal cord injuries, Goffer developed the ReWalk. “The person walks the system, the system does not walk them,” Goffer said. “The users are in control — when they want to sit, they sit, when then want to stand and walk, they do so.”

“This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries,” said Larry Jasinski, CEO of ReWalk Robotics, formerly Argo Medical Technologies. “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. Now, with FDA clearance, users will continue to experience these benefits on a daily basis at home.”