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FDA Approves Motorized Exoskeleton for Spinal Cord Injury

ReWalk system

ReWalk system (Argo Medical Technologies Inc.)

27 June 2014. The Food and Drug Administration yesterday cleared for sale in the U.S. a motorized exoskeleton system for people with lower-body paralysis from spinal cord injury. The device, called ReWalk, is made by Argo Medical Technologies in Marlborough, Massachusetts, and according to FDA, the first system of its kind approved to help people with lower body paralysis, also known as paraplegia.

Centers for Disease Control and Prevention estimate 200,000 Americans suffer from spinal cord injuries, with 12,000 to 20,000 new cases occurring each year. Nearly half (46%) of spinal cord injury cases are due to auto accidents, and males account for 8 in 10 spinal cord injury patients.

ReWalk makes it possible for people with lower body paralysis to walk independently, controlled by feedback from sensors to allow for a natural walking gait. The user wears a metal brace fitted over the legs and part of the upper body. The system includes motors that provide movement at the hips, knees, and ankles. In addition, the user wears a backpack containing the computer controller and power supply.

A remote control device worn on the wrist tells ReWalk to stand, sit, or walk. The wearer also uses crutches for extra support and stability when walking and standing.

FDA approved ReWalk for personal use for patients with paralysis from injuries occurring between the 7th thoracic to 5th lumbar vertebrae, when assisted by a trained caregiver. The agency also approved ReWalk for use in rehabilitation facilities for people with with injuries occurring between the 4th and 6th thoracic vertebrae. Patients need to be healthy enough to stand with a standing frame, support themselves on crutches or a walker, and undergo training on the device with their caregivers.

FDA reviewed ReWalk under its de novo classification process that provides a pathway for new types of medical devices with low to moderate risk to patients. The agency based its approval on a clinical study with 30 spinal cord injury patients in the U.S. and Italy that assessed ReWalk’s safety and ability to provide assistance for walking over various distances.

The approval also considered reports from 16 other users citing the system’s ability to help users walk on various surfaces and with varying degrees of help from caregivers. Under the approval, the company is required to maintain a registry of ReWalk users to collect reports of adverse events with the device and assess the adequacy of training for users and caregivers.

Argo Medical Technologies was founded in 2001 by Israeli engineer and entrepreneur Amit Goffer, who became a quadriplegic as a result of an accident. Much of the intervening time was spent on research and development of ReWalk, which was made first for rehabilitation hospitals, and then for personal use. The company now has offices in Germany and Israel, as well as the U.S.

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