FDA approves Israel’s ReWalk device enabling paraplegics to walk

In the US, the ReWalk system is currently used in rehabilitation clinics, but now that it has received FDA clearance, marketing there may begin.

By JUDY SIEGEL-ITZKOVICH
A man in a wheelchair [Illustrative]. (photo credit: Carlos Jasso/Reuters)
A man in a wheelchair [Illustrative].
(photo credit: Carlos Jasso/Reuters)
ReWalk, an Israeli-developed “exoskeleton” device that enables people paralyzed in the lower parts of their bodies to stand and walk, has been approved for use by the US Food and Drug Administration. The device was viewed by US President Barack Obama during his visit to Israel last year.
ReWalk was developed by Dr. Amit Goffer, who is quadriplegic.
He founded Argo Medical Technologies in 2001 to create a patented product that would enable persons with spinal cord injuries to walk again. Over the past decade, Argo has grown from a small research and development start-up based in Israel to an international company with headquarters in the US, Germany, and Israel.
Launched in 2012, the ReWalk Personal is currently available throughout Europe.
In the US, the ReWalk system is currently used in rehabilitation clinics, but now that it has received FDA clearance, marketing there may begin.
The prices have not officially been publicized, but news reports give the cost as between $65,000 to $68,000.
A paralyzed person wears the device, which is an “external robot” that moves the hips and knees so they can walk even though the nerves are damaged and do not function. Paralysis victims can thereby get up from their wheelchairs and move about on their legs, looking at others from normal height.
They need to wear a backpack carrying the ReWalk’s computer and battery.
“This revolutionary product will have an immediate positive effect on the quality of life of people with spinal-cord injuries,” said company CEO Larry Jasinski. “For the first time, paraplegics will be able to take the device home and use it every day.”
Capt. Derek Harare, a paraplegic in the US Marine Corps who has been training with ReWalk, will be one of the first Americans to buy one. “It will be wonderful for me to use the system and stand up and walk on my own,” he said.
The technology combines a controlling device, movement centers, and a wearable support, based on the natural walking movements of the legs. Studies have shown that users improve their cardiovascular health, halt the loss of fat tissue, and boost their muscle and gastrointestinal performance.
They also suffer less pain, need to be hospitalized less, and need to take less medication.
Argo has two models: ReWalk Personal and ReWalk Rehabilitation. The first is customized to the user for daily usage at home or outside in various field conditions. The second system is used for clinical rehabilitation in institutions for training and therapy and for training paraplegics for eventually using their own personal system.
“The person directs the system using a device attached to the wrist that has buttons; it does not lead him,” said Goffer.
“When they want to sit down, they sit. When they want to get up and walk, they do.” However, it is reportedly not suitable for going up stairs.