Argo Medical Technologies has received marketing approval from the US Food and Drug Administration (FDA) for its first motorised device called ReWalk, intended to act as an exoskeleton for people with lower body paralysis (paraplegia) due to a spinal cord injury.
Worn over the legs and part of the upper body, the device helps an individual sit, stand and walk with a little motorised help.
In the US, there are approximately 200,000 people with a spinal cord injury, with many having complete or partial paraplegia, according to the US Centers for Disease Control and Prevention.
FDA Center for Devices and Radiological Health’s Office of Device Evaluation director Christy Foreman said: "Along with physical therapy, training and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities."
The device features a wearable metal brace that supports the legs and part of the upper body. In addition, it comprises motors that supply movement at the hips, knees and ankles, a tilt sensor, and backpack that includes computer-based control system.
ReWalk is controlled using a wireless remote control worn on the wrist, while crutches provide the user with additional stability when walking, standing and rising up from a chair.
The device is intended for people with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 when accompanied by a specially trained caregiver, as well as for people with spinal cord injuries at levels T4 to T6 where the device is limited to use in rehabilitation institutions.
The FDA said that the device is not intended for sports or climbing stairs.
Before being trained to use ReWalk, patients should be able to stand using an assistive standing device, and their hands and shoulders should be able to support crutches or a walker.
Patients with a history of severe neurological injuries other than spinal cord injury, or have severe spasticity, significant contractures, unstable spine, unhealed limb fractures or pelvic fractures are suggested not to use the device.
In order to evaluate safety and effectiveness of ReWalk, the FDA reviewed testing performed to assess the device’s durability, hardware, software and battery systems, and other safety systems that help reduce risk of injury if the device loses balance or power.
The FDA is requiring Argo to complete a post-market clinical study that will include a registry to collect data on adverse events related to the use of the ReWalk device and prospectively and systematically assess the adequacy of its training programme.