ReWalk Robotics Ltd has submitted a 510(k) application to the US Food and Drug Administration (FDA) for the ReStore exo-suit for gait training during stroke rehabilitation—the next step in the commercialization process, according to the company.

Introduced in 2017, the ReStore soft garment-like exo-suit is designed to allow variability of movement in combination with active ankle assistance that adaptively synchronizes with the patient’s natural gait, to facilitate functional gait training activities. The device also provides therapists the ability to adjust and optimize a patient’s treatment using real-time analytics.

”This submission marks a significant milestone for robotic rehabilitation technologies and represents a clear, distinct evolution in powered rehabilitation solutions,” says Larry Jasinski, ReWalk CEO, in a media release from the Marlborough, Mass-based company.

“The ReStore is a versatile device which will provide high-level, reproducible care for a broad range of a clinic’s gait training clients, at a price point accessible to many more clinics than current technologies.”

The 510(k) submission follows the completion of a nationwide clinical study, with 44 patients enrolled across five leading rehabilitation centers in the United States:

  • The Shirley Ryan AbilityLab in Chicago
  • Spaulding Rehabilitation Hospital in Boston, in partnership with Boston University College of Health and Rehabilitation Sciences: Sargent College
  • MossRehab Stroke and Neurological Disease Center in Elkins Park, Pa
  • TIRR Memorial Hermann in Houston
  • Kessler Foundation in West Orange, NJ

“As part of the multi-site study of the ReStore exo-suit, we applied the device to a broad range of individuals with post-stroke gait dysfunctions. The device allowed the study participants to walk effectively and efficiently, and we are encouraged with the potential of this technology to interact with and enhance everyday clinical care” explains Arun Jayaraman, PT, PhD, who is director of the Max Nader Lab for Rehabilitation Technologies & Outcomes Research at Shirley Ryan AbilityLab and lead investigator for the ReStore clinical study.

Following CE submission in Q4 of 2018, ReWalk anticipates commercializing the ReStore device for use by stroke patients and rehab clinics in Europe in mid-2019. In the United States a  potential launch of the product could occur in late Q2 or Q3, pending clearance from the FDA, per the release.

[Source(s): ReWalk Robotics Ltd, PR Newswire]