Recently, the US Food and Drug Administration (FDA) announced approval for ReWalk to be marketed. ReWalk is the first motorized device intended to act as an exoskeleton for people with lower body paralysis due to a spinal cord injury. "Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility," said Christy Foreman, director of the Office of Device Evaluation, at the FDA's Center for Devices and Radiological Health. "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."
According to the United States (US) Centers for Disease Control and Prevention (CDC), there are about 200,000 people in the United States living with a spinal cord injury (SCI), many of whom have complete or partial paraplegia. The CDC estimates that there are 12,000-20,000 new spinal cord injury patients annually with motor vehicle accidents as the leading cause in this increase.
It is estimated that the average medical cost for patients with spinal cord injuries is between $15,000 and $30,000 per annum. Over a lifetime, costs have been estimated between $500,000 to more than $3 million depending on injury severity.
According to the CDC, the primary causes of spinal cord injury include:
While motor vehicle crashes remain the number-one cause of spinal cord injury, safety belt use can help reduce injury by 60%. Wearing a safety belt in a vehicle with an airbag, can help decrease the risk for spinal cord injury by 80%.
ReWalk consists of a fitted, metal brace that supports the legs and part of the upper body. The device uses motors that supply movement at the hips, knees, and ankles; a tilt sensor; and a backpack that contains the computer and power supply. Using a wireless remote control (worn on the wrist), the user can issue commands that make ReWalk stand up, sit down, and walk. Patients using the system are advised to use crutches for additional stability when walking, standing, and rising up from a chair.
Before its release, the FDA performed clinical tests and reviewed study-related data to assess ReWalk's durability, its hardware, software and battery systems, and other safety systems that help minimize risk of injury should the device lose balance or power.
Outcome clinical data was obtained from 30 study participants. The study assessed patients’ ability to walk various distances and the amount of time needed to walk various distances. Further measurements included ReWalk’s performance on different types of walking surfaces, slight slopes, and moving surfaces. In addition, 16 other patients were observed using ReWalk on walking surfaces found in home and community environments with differing levels of assistance from trained companions.
The FDA determined risks associated with using ReWalk include:
Patients who use the device are required to have a caregiver and undergo training developed by the manufacturer to learn and demonstrate the proper use of the device.