Parker Hannifin Corp. has entered into clinical trial agreements with four rehabilitation institutions in the United States to support the testing and development of the Indego exoskeleton.
Indego is poised to become the first powered exoskeleton or powered orthotic device to receive FDA approval, according to a news release. Parker has been in discussions with the agency during the past year to determine the appropriate classification of the device and obtain input into the design of the clinical trials.
Parker has formalized clinical trial agreements with the Rehabilitation Institute of Chicago; Kessler Foundation/Kessler Institute for Rehabilitation, West Orange, NJ; Rusk Rehabilitation at New York University Langone Medical Center, New York; and Craig Hospital, Denver. Parker is currently developing a second generation device for clinical trials starting in July 2014 to support submission for FDA approval, and is working to secure the regulatory approvals and CE marking for Indego in Europe. Pending regulatory approvals, Parker is targeting commercial launch of Indego in Europe in early 2015 and in the US in 2016.
“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.”