The FDA has approved an expanded indication for the Indego exoskeleton, developed by Parker Hannifin, to include patients at rehabilitation facilities with spinal cord injury at C7 and lower injury levels, as well as patients in home and community settings with T3 and lower injury levels.
According to a company press release, the indication-for-use (IFU) approval follows the successful implementation of an FDA 522 post-market surveillance study. In addition, the Parker Hannifin is conducting two ongoing clinical trials to provide evidence to support submissions for FDA clearance of future software features and functionalities that can be applied to the device.
“The new clearance by the FDA provides the Indego exoskeleton with the broadest IFU 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 the 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 [U.S. Department of Veterans Affairs] VA 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.”
The Indego exoskeleton was launched commercially in May 2016. According to Parker Hannifin, the company is developing new, powered and programmable variants of the Indego for patients with multiple sclerosis, stroke and musculoskeletal weakness.