Health & Medicine
First Motorized Device Approved by FDA to Help People With Spinal Cord Injuries to Walk
Benita Matilda
First Posted: Jun 27, 2014 06:33 AM EDT
The U.S. Food and Drug Administration approved marketing of the first motorized device that helps people with certain spinal cord injuries to walk.
ReWalk is the first motorized device to win approval from the U.S. federal regulators. It is designed to work as an exoskeleton for those with lower body paralysis (paraplegia) due to injury in the spinal cord. This device is to be worn over the legs and part of the upper body and helps individuals to sit, stand and walk with some aid. It is for those with paraplegia due to spinal cord injuries at levels T7 - L5, also those with injuries at levels T4 -T6.
The U.S. Centres for Disease Control and Prevention reveals that there are nearly 200,000 Americans surviving with spinal cord injury and most of them have complete or partial paraplegia.
"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."
The motorized device is fitted with a metal brace that offers support to the legs and the upper part of the body, motors that supply movement at hips, knees and ankles, a tilt sensor and a backpack that has the computer and power supply. The user gets more support when walking, standing and rising up. Using a wireless remote control strapped to the wrist one can give commands to help stand up, sit down or walk. This device is not approved for sports or climbing stairs.
Those with a history of severe neurological injuries, spasticity, contractures, unstable spine, unhealed limb fractures or pelvic fractures cannot use the device. People with infections, circulatory conditions, heart or lung conditions or pressure scores should refrain from using this device.
The authorities reviewed the data of 30 study participants. The test assessed the subject's ability to walk to several distances, the time taken to walk the distances and performance on different walking surfaces. The risk of physical effects was assessed.
The risks include pressure sores, bruising, falls and related injuries, and diastolic hypertension during use.
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First Posted: Jun 27, 2014 06:33 AM EDT
The U.S. Food and Drug Administration approved marketing of the first motorized device that helps people with certain spinal cord injuries to walk.
ReWalk is the first motorized device to win approval from the U.S. federal regulators. It is designed to work as an exoskeleton for those with lower body paralysis (paraplegia) due to injury in the spinal cord. This device is to be worn over the legs and part of the upper body and helps individuals to sit, stand and walk with some aid. It is for those with paraplegia due to spinal cord injuries at levels T7 - L5, also those with injuries at levels T4 -T6.
The U.S. Centres for Disease Control and Prevention reveals that there are nearly 200,000 Americans surviving with spinal cord injury and most of them have complete or partial paraplegia.
"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."
The motorized device is fitted with a metal brace that offers support to the legs and the upper part of the body, motors that supply movement at hips, knees and ankles, a tilt sensor and a backpack that has the computer and power supply. The user gets more support when walking, standing and rising up. Using a wireless remote control strapped to the wrist one can give commands to help stand up, sit down or walk. This device is not approved for sports or climbing stairs.
Those with a history of severe neurological injuries, spasticity, contractures, unstable spine, unhealed limb fractures or pelvic fractures cannot use the device. People with infections, circulatory conditions, heart or lung conditions or pressure scores should refrain from using this device.
The authorities reviewed the data of 30 study participants. The test assessed the subject's ability to walk to several distances, the time taken to walk the distances and performance on different walking surfaces. The risk of physical effects was assessed.
The risks include pressure sores, bruising, falls and related injuries, and diastolic hypertension during use.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone