Exoskeleton technology has enabled the impossible, helping individuals who have been partially paralyzed from spinal cord injuries walk again. But that feat has long come with a caveat: The personal exoskeleton devices so far authorized by the FDA could only be used to help wearers walk on flat ground, leaving them unable to mount stairs, curbs and other non-handicap-accessible obstacles.
Until now, that is. ReWalk Robotics’ eponymous exoskeleton system has received the agency’s clearance to help users surmount stairs and curbs, according to a Tuesday announcement. According to the company, the ReWalk device is the first to be cleared in the U.S. for that indication.
“Our mission at ReWalk has been to achieve widespread access to the health benefits of walking in everyday life for individuals with spinal cord injury,” CEO Larry Jasinski said in the company release. “Today’s announcement demonstrates our commitment from a technical perspective to improve access to a broader range of activities of daily living, such as walking up the steps to visit a friend’s home or stepping over a curb during a neighborhood walk.”
Each of the ReWalk exoskeletons are specifically fitted to each user. The rigid, battery-powered suits include motors at the hip and knee joints that help move the legs according to button controls on the wrists. The device’s movement also automatically adjusts according to movements of the wearer’s torso, tracked by a wide band worn around the midsection.
With the addition of the stair-stepping abilities, users can raise their legs higher using either the controls on the wrist or buttons located on the hips.
ReWalk submitted the upgrade for FDA review last year, Jasinski said during an earnings call last month. The review was slightly slowed down by an agency request for more information about the system, including additional usability data, but, according to the CEO, “We promptly set up and conducted the required study, and this additional information was subsequently submitted to the FDA for consideration.”
Among the data submitted to the FDA were real-world reports from 47 European users of the high-stepping system, spanning about seven years and more than 18,000 stairs surmounted to prove safety and efficacy.
The new feature has already been in use in Europe for years, since its original 2012 CE mark included approval for the technology to climb steps and curbs, according to ReWalk. In the U.S., the system has been cleared for personal use—beyond rehab centers—since 2014, but could only help wearers walk across flat ground for the first decade.
The ReWalk exoskeleton device is now in its sixth iteration, with a seventh-generation version already in development, the CEO said on the earnings call.
According to its maker, the system is meant to be used only by people with paraplegia or paresis after spinal cord injuries, since they must have control not only of their trunk but also their hands, arms and shoulders so they can control movement and use crutches for further stability. They should also have full range of motion available throughout their lower extremities so that the exoskeleton can mimic a normal gait pattern.
Additionally, the company’s exoskeletons are only meant to be used alongside a trained companion who can help the wearer if necessary.