The FDA has approved an Israeli device that allows stroke victims who are paralyzed to walk again on their own!
PR Newswire (h/t Mike F) ReWalk Robotics, Ltd. (Nasdaq: RWLK), a leading manufacturer of robotic medical devices for individuals with lower limb disabilities, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s ReStore soft exo-suit system for sale to rehabilitation centers across the United States.
ReStore is the only soft exo-suit with FDA clearance, and is intended for use in the treatment of stroke survivors with mobility challenges. Stroke is a leading cause of disability, which affects approximately 17 million people worldwide each year, and as many as 80% of people who have had a stroke will suffer from gait impairments.
“The exo-suit achieves our commercial goal to offer a functional and affordable system that can be utilized in the ‘Main Street’ clinics in every community,” said ReWalk CEO Larry Jasinski.
“We are very encouraged by our initial experience and positive impact of ReStore in gait training for persons with stroke residual disabilities,” said Moss Rehab’s Chief Medical Officer Alberto Esquenazi, MD, who was one of the investigators in the multi-center trial. “By training the patient walking pattern in a more correct way, the expectation is that the brain will re-learn and better restore the walking function lost after a stroke.” It is also expected to help people with other diseases, such as multiple sclerosis and Parkinson’s disease, and also potentially be used by a person at home and in their community.
ReStore is ReWalk’s second major market segment, joining the ReWalk Personal 6.0 (below). ReWalk which received FDA approval in 2014, is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal cord injury (SCI) to stand upright, walk, turn, and climb and descend stairs. ReWalk was the first exoskeleton to receive FDA clearance for personal and rehabilitation use in the United States.
To date, ReWalk has placed nearly 550 exoskeletons in 26 countries and trained more than 270 rehabilitation clinics to conduct exoskeleton training worldwide.
Founded in 2001, ReWalk has headquarters in the United States, Israel and Germany. For more information on the ReWalk systems, please visit www.rewalk.com.
This FOX video of the two devices is from April 2018, before the new ReStore device had received FDA approval: