The US Food and Drug Administration (FDA) has cleared an expanded indication for the Indego exoskeleton (Parker Hannifin), a device that allows individuals with paraplegia to stand and walk, the company has announced.
The Indego exoskeleton was previously cleared by the FDA in February 2016 for use by individuals with spinal cord injury levels of T4 and lower in rehabilitation facilities, and with T7 and lower injury levels for use in home and community settings.
Indego exoskeleton
The new indication expands the population that can use the device to include patients with spinal cord injury at C7 and lower injury levels in rehabilitation facilities and T3 and lower injury levels for use in home and community settings.
“The new clearance by the FDA provides the Indego exoskeleton with the broadest IFU [indication for use] of any commercial exoskeleton available in the United States,” Achilleas Dorotheou, head of the human motion and control business unit for Parker Hannifin, said in a news release.
“Indego is now available to a significantly larger segment of the spinal cord injury population and is an option for personal use among more than 40% of spinal cord injured Americans. We credit several VA [Veterans Affairs] medical directors with urging us to pursue this expanded clearance and it is likely that some of the 40,000 spinal cord injured veterans served by the VA system will be among the immediate beneficiaries,” Dorotheou added.
The company also said it’s working on new powered and programmable variants of Indego to be submitted for regulatory approval over the next several years that will address other partial or moderate impairments, such as multiple sclerosis, stroke, and musculoskeletal weakness.
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