More than 85,000 Canadians are afflicted by spinal cord injuries, with about 4,000 new cases occurring each year. In the US, that number climbs to around 200,000 paralyzed patients per year. 50% of the time, the spinal cord has been damaged by a traumatic event, like a car crash – and the remaining 50% of paralysis cases are caused by degenerative conditions like ALS and cancer.
Victims of paralysis face the tremendous struggle of adjusting to life with dramatically restricted physical mobility. They’re up against mental and psychological challenges most of us can barely imagine. Despite the enormous need, clinical research has failed to find a way to repair damaged spines and restore movement to paralyzed people. At least, up until now.
The recently FDA approved mobility system called the ReWalk is an inspiring leap in the right direction. The device may not provide a cure for paralysis, but it’s helping patients achieve the kind of mobility they never thought possible.
Remote-Controlled Exoskeleton Moves On Demand
The ReWalk is a supportive exoskeleton that includes leg braces, motion sensors, motorized joints, a computer, and a wireless remote control. Using the remote control, which is strapped to the wrist, patients tell the system in what way they would like to move: stand, sit, or walk.
With the additional support of crutches and under supervision of a care-giver, users can leave their wheelchair behind and navigate throughout their homes and communities with relative ease. The technology comes in two sizes and can support weight of up to 220 pounds.
Much Anticipated Home Approval
The ReWalk was developed by Amit Goffer (Argo Medical Technologies), who was rendered paralyzed by a 1997 car crash. Initially the device was approved in the United States for use only in medical rehabilitation facilities – patients have been anxiously awaiting its release as a home-based mobility tool. Much like the rigours associated with pharmaceutical testing, medical devices must satisfy federal quality assurance and quality control guidelines before earning approval for general market release. Pharmaceutical and medical device research and development are among the most regulated industries in the world. On June 26th, the FDA finally gave ReWalk its stamp of approval, helping CEO Goffer realize his goal of making the exoskeleton available to American consumers. Already on shelves in Europe, the system should be available in Canada soon.
Diverse Health Benefits
Being able to get up and move creates a ripple effect, improving the health of paralyzed patients in numerous ways. Immobility can wreak havoc with patients’ digestive, cardiovascular, urinary and respiratory systems, leading to a host of related medical conditions. The ReWalk, by helping paralyzed people stand and walk, has been shown to reduce risk factors like weight gain and muscle loss – during trials, subjects also reported improvements in digestion and circulation.
Of course the boost in morale, self-confidence, and faith in continued innovation are the biggest rewards here. The ReWalk is truly redefining the future for victims of paralysis and reduced mobility. Students in professional regulatory affairs learn about clinical studies and regulatory strategies for pharmaceutical manufacturing and medical devices.
What other ways do you see patients interfacing with wearable tech to improve their overall health?