FDA Clears ReStore Exo-Suit for Stroke Rehabilitation

Alberto Esquenazi, MD

The FDA has granted clearance to ReWalk Robotics’ ReStore exo-suit intended for the treatment of gait impairments in stroke survivors.

The device is the only soft exo-suit cleared by the FDA. The patented technology was originally developed at Harvard University’s Wyss Institute for Biologically Inspired Engineering.

Data from a multi-center clinical trial launched in Spring 2018 was used to support ReStore’s 510(k) submission with the FDA. Results of that study, which enrolled 40 participants, are expected to be published later this year. Participating clinical study sites included the Shirley Ryan AbilityLab in Chicago, IL, Spaulding Rehabilitation Hospital in Boston, MA, the MossRehab Stroke and Neurological Disease Center in Elkins Park, PA, TIRR Memorial Hermann in Houston, TX, and the Kessler Foundation in East Hanover, NJ.

“We are very encouraged by our initial experience and positive impact of ReStore in gait training for persons with stroke residual disabilities," said Moss Rehab's chief medical officer Alberto Esquenazi, MD, one of the investigators in the multi-center trial, in a statement. “By training the patient walking pattern in a more correct way, the expectation is that the brain will relearn and better restore the walking function lost after a stroke.”

The system consists of a soft, garment-like design connected to a waist pack and mechanical cables that allow the patient’s affected leg to be lifted in synchronized timing with their natural walking pattern. While the device applies force to the body, it does not restrict how a person moves, providing targeted assistance during forward propulsion and ground clearance. The device also records data that can be shared with a health care provider to further inform treatment and rehabilitations strategies.

"We are enthusiastic about the new soft exo-suit technology for post stroke rehabilitation and are encouraged by the preliminary data we collected as part of this multi-center clinical trial," Karen Nolan, PhD, a senior research scientist at the Center for Mobility and Rehabilitation Engineering Research at Kessler Foundation, told NeurologyLive. "This new device offers a lower-profile device that dynamically assists the ankle joint during walking for individuals with post stroke motor impairment. The device can be used over ground or on the treadmill to specifically assist the foot and ankle during walking."

"Kessler Foundation has used this technology with individuals poststroke as part of the multi-center clinical trial," Nolan continued. "The physical therapists were very excited to have a robotic device that could treat ankle impairment and provide a larger range of motion with a low profile robotic design."

The ReStore suit is ReWalk's third product in this segment, joining the ReWalk Personal 6.0, which is a robotic exoskeleton made for home use in patients with paralysis associated with spinal cord injury, and the ReWalk Rehabilitation system, which allows for multi-patient use through adjusted height and weight parameters. To date, nearly 550 exoskeletons have been distributed across 26 countries.

“This technology has broad potential, and we are currently testing additional concepts which can be applied to provide therapy and/ or mobility assistance for individuals with other diseases, such as multiple sclerosis and Parkinson's disease, and also potentially be used by a person at home and in their community," said Conor Walsh, PhD, associate professor of engineering and applied sciences at the John A. Paulson Harvard School of Engineering and Applied Sciences and a core faculty member at the Wyss Institute for Biologically Inspired Engineering, in a statement.

The device will have a launch price of $28,900, with purchase and leasing options available.

REFERENCE

FDA issues clearance for the ReStore™ Exo-Suit, the first soft robotic system for stroke therapy [news release]. Marlborough, MA: ReWalk Robotics Ltd. June 4, 2019. prnewswire.com/news-releases/fda-issues-clearance-for-the-restore-exo-suit-the-first-soft-robotic-system-for-stroke-therapy-300861824.html. Accessed June 4, 2019.