Parker Hannifin Corporation announced in a press release that it has entered into clinical trial agreements with four top-rated U.S. rehabilitation institutions to support the testing and development of the Indego exoskeleton, which is a robotic exoskeleton or powered orthotic device that allows users to stand and walk.
The corporation is currently developing a second generation device for clinical trials scheduled to start in July 2014 to support submission for FDA approval. Pending regulatory approvals, Parker officials stated in the release they are targeting commercial launch of Indego in Europe in early 2015 and in the United States in 2016.
Parker aims at having Indego become the first powered exoskeleton or powered orthotic device to receive FDA approval and has been in discussion with the FDA to determine the appropriate classification of the device and obtain input into the design of the clinical trials, according to the press release.
“Our objective is to bring Indego to market to enable people who were told they would never walk again to stand upright and walk and to provide a new level of independence,” Achilleas Dorotheou, head of the human motion and control business unit for Parker, stated in the release. “We have engaged in discussions with the FDA, payers and administrators to best position the commercial launch of Indego. With these agreements we will be working with the best and most respected rehabilitation clinicians and researchers in the country gathering evidence that demonstrates the safety of Indego and proves its tangible clinical and economic benefits.”