Federal health regulators on Thursday have approved a first of a kind set of robotic leg braces that can help some disabled or paraplegic people walk again.
The ReWalk system functions like an exoskeleton for people paralyzed from the waist down, allowing them to stand and walk with assistance from a caretaker. The device consists of leg braces with motion sensors and motorized joints that respond to subtle changes in upper body movement and shifts in balance.
A harness around the patient’s waist and shoulders keeps the suit in place and a backpack holds the computer and rechargeable battery. Crutches are used for stability. ReWalk is intended for people who are disabled due to certain spinal cord injuries. The device was developed by the founder of Israel based Argo Medical Technologies, who was paralyzed in a 1997 car crash.
“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,” said Larry Jasinski, CEO of Argo Medical Technologies which makes the suit.
“It will be incredible for me to regain independence, to use the system to walk and stand on my own,” said Derek Herrera, a Marine captain who’s getting one. “I see this as a milestone for people in my same situation who will now have access to this technology and experience walking again and all of the health benefits that come with ReWalking.”
Studies show not only does the device help patients walk on their own but they regain muscle strength, stamina and other benefits.
Patients must also use crutches to support themselves, and they still need help from a trained companion, the FDA said. Patients themselves require substantial training.
The specific approved indication is for patients with lower-body paralysis from spinal cord injuries at levels T7 to L5 and for injuries at levels T4 to T6 when use is limited to rehabilitation centers.
ReWalk’s efficacy in the clinical setting was evaluated in tests involving 30 patients as well as observational data from 16 patients using the device at home and in community settings.
The device is not without adverse effects, the FDA noted. Users developed pressure sores, bruises and scrapes, injuries from falls and diastolic hypertension while wearing the device. However, the agency determined that the overall risks were low to moderate, allowing approval through the de novo classification process.
Argo will be required to conduct a post marketing study of adverse events and to evaluate the adequacy of the training program for patients and caregivers, the FDA said.