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| Argo Medical Technologies' ReWalk exoskeleton--Courtesy of Argo Medical Technologies |
Argo Medical Technologies scored FDA clearance for the first robotic exoskeleton to help people with spinal cord injuries walk.
The Marlborough, MA-based company won approval for its ReWalk device through the agency's de novo classification process, a regulatory pathway for "first-of-its-kind" medical devices that are considered low to moderate risk. The exoskeleton is worn over the legs and part of the upper body, and helps individuals sit, stand and walk with help from a trained companion, Bloomberg reports. The product consists of a fitted, metal brace that supports the knees and upper back; motors at the hips, knees and ankles; a tilt sensor; and a backpack that holds a computer and power supply.
Patients can command ReWalk to stand up, sit down or walk using a wireless remote control worn on the wrist, and use crutches for extra stability. The entire device weighs 46 pounds, 5 of which are felt through the backpack, according to Bloomberg. Argo Medical is required to complete a post-market clinical study to collect adverse event as part of the device's clearance.
There are about 200,000 people in the U.S. with spinal cord injuries, many of whom have complete or partial paraplegia, according to the U.S. Centers for Disease Control and Prevention. ReWalk was approved for individuals with paraplegia due to spinal cord injuries at levels T7, the seventh thoracic vertebra, to L5, the fifth lumbar vertebra. The device is custom-fit for each user, and patients and caregivers must undergo training before using the product, the FDA said in a statement.
"This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries," CEO of ReWalk Robotics Larry Jasinski said in a statement. "For the first time individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and maximize on the physiological and psychological benefits we have observed in clinical trials."
Argo Medical is not the only company developing robotic exoskeleton devices for patients with spinal cord or brain injuries. In 2012, Ekso Bionics created a self-contained, full-body robotic walking suit with mechanical braces and electronic crutches. The company has already secured a CE mark for its product and supplies the bionic suits to rehab centers in the U.S., Europe and South Africa.
- read the Bloomberg story
- here's the FDA's statement
- here's Argo Medical Technologies' statement