ReWalk has come a long way since it was first developed by Dr. Amit Goffer, the Israeli inventor who became quadriplegic after an ATV accident in 1997. ReWalk Robotics (formerly Argo Medical Technologies) has announced that the U.S. Food and Drug Administration approved the company’s ReWalk Personal System for home use. As a robotic exoskeleton that powers hip and knee motion, ReWalk enables patients with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra) to stand upright and walk. After multiple clinical studies, ReWalk is now the only exoskeleton in the United States with FDA clearance. The FDA had to review the ReWalk under its de novo classification process due to the novelty of the product as a first-of-its-kind medical device.
Larry Jasinski, CEO of ReWalk Robotics, commented on the announcement: “This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries. For the first time individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and maximize on the physiological and psychological benefits we have observed in clinical trials.”
ReWalk consists of a customized metal brace that supports the legs and part of the upper body, motors that supply movement at the hips, knees, and ankles, a tilt sensor, and a backpack that contains the computer and power supply. Crutches provide the user with additional stability when walking, standing, and rising up from a chair. Using a wireless remote control worn on the wrist, the user commands ReWalk to stand up, sit down or walk. All of these parts work together to replicate a natural gait experience.
The company also produces the ReWalk Rehabilitation system for clinical rehabilitation environments, aiding with exercise and therapy training for individuals before they are able to use the Personal system. Patients wanting to use the ReWalk Personal System must meet criteria from a medical examination alongside the required training program.
Product page: The ReWalk Personal System…