China-made exoskeleton robot gives hope to paraplegics



'Exoskeleton' Gives New Hope to Paraplegics

ReWalk, a motorized, wearable device that helps paraplegics sit, stand, and walk, wins FDA approval.

By John Gever, MedPage Today

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Patients must also use crutches to support themselves with ReWalk, and they still need help from a trained companion.
Patients must also use crutches to support themselves with ReWalk, and they still need help from a trained companion.
Getty Images

A motorized, wearable device that allows paraplegic individuals to sit, stand, and walk -- with assistance from another person -- won approval from the FDA on Thursday.

Called ReWalk and manufactured by Argo Medical Technologies of Marlborough, Mass., the device is often called an "exoskeleton" because it fits over most of the wearer's body. It includes a metal brace supporting the legs and lower torso, held in place with a harness worn over the shoulders and around the chest.

Battery-powered motors provide movement at the ankles, knees, and hips. The device is controlled by a computer worn as a backpack, which also contains the power supply. The patient uses a wireless remote worn on the wrist to initiate standing, sitting, and walking.

Patients must also use crutches to support themselves, and they still need help from a trained companion, the FDA said. Patients themselves require substantial training.

RELATED: Paraplegics Get Leg Function Back With Electrical Stimulation

The specific approved indication is for patients with lower-body paralysis from spinal cord injuries at levels T7 to L5, and for injuries at levels T4 to T6 when use is limited to rehabilitation centers.

ReWalk's efficacy in the clinical setting was evaluated in tests involving 30 patients, as well as observational data from 16 patients using the device at home and in community settings.

The device is not without adverse effects, the FDA noted. Users developed pressure sores, bruises and scrapes, injuries from falls, and diastolic hypertension while wearing the device. However, the agency determined that the overall risks were low to moderate, allowing approval through the de novo classification process.

Argo will be required to conduct a postmarketing study of adverse events and to evaluate the adequacy of the training program for patients and caregivers, the FDA said.






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Date: 15.12.2018, 17:10 / Views: 32353