A media release from the company explains that the Indego exoskeleton was previously cleared by the FDA in February 2016 for use by individuals with SCI levels of T4 and lower in rehabilitation facilities, and with T7 and lower injury levels for use in home and community settings.
The new indication for use (IFU) cleared by the FDA now includes SCI patients at C7 and lower injury levels in rehabilitation facilities and T3 and lower injury levels for use in home and community settings.
The expanded clearance was granted as the result of the successful implementation of an FDA 522 Postmarket Surveillance Study, along with two ongoing clinical trials designed to provide evidence supporting future submissions for FDA clearance for additional software suites and functionalities that will further enhance Indego’s value in rehabilitation centers.
“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,” says Achilleas Dorotheou, head of the Human Motion and Control business unit for Parker, in the release.
“We credit several 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.”
[Source: Parker Hannifin]