US : FDA clears robotic legs that help paraplegics walk

Some paraplegics could be closer to walking now that U.S. authorities approved a new exoskeleton device that will help some of them stand and walk.

The ReWalk device, which has been available in Europe since 2012, can be worn over legs to help people with certain types of injuries regain their mobility. On Thursday, the Food and Drug Administration approved marketing for the product, developed by Argo Medical.

“This is the best news,” said retired Sgt. Terry Hannigan, a Vietnam veteran. “It took everything I had not to cry.”

Hannigan has used the ReWalk in a clinic, but up until now had not been able to buy one herself. Getting the $69,500 needed to buy one shot to the top of her list overnight, she said. When word began to spread that ReWalk was approved for home use, Hannigan got dozens of calls and messages from friends and family.

“It gives me the choice of being able to get my independence back,” she said. “Now I don’t need somebody to open up a cabinet up high.”

The battery-powered system uses motion sensors and a computer to figure out when the user is moving. The computer and power supply are in a backpack worn by the user and it is controlled by a wireless remote worn on the wrist. Crutches are used for stability.

The device was designed by Amit Goffer, founder of Israel-based Argo Medical Technologies, which has its U.S. headquarters in Marlboro. Goffer was paralyzed in a 1997 car crash. The company has offered a clinical version of the exoskeleton for years, but with the FDA clearance it can now be bought by individuals and used unsupervised.

“This is for a guy who wants to walk with his family, or walk around the office and not be in a wheelchair,” said Larry Jasinski, CEO of Argo Medical Technologies. “In a wheelchair, you lose human contact.”

Dan Meninger, program manager for spinal cord injuries at Spaulding Rehabilitation, said exoskeletons like ReWalk provide medical benefits such as reducing the risk of infection and being able to get exercise beyond the mental boost patients get.

“There are certainly numerous benefits from a medical perspective,” he said.

ReWalk is not the only company developing this kind of technology, but its exoskeleton is the first to be FDA approved for home use.

The exoskeleton is not covered by insurance right now, but Jasinski said that barrier is “the next stage.”

Agencies/Canadajournal