Craig Hospital, headquartered in Englewood, Colo, has announced that it will be participating in a clinical trial for the Indego exoskeleton. The hospital notes that it is among four leading rehabilitation centers participating in the trial.
In preparation for the July clinical trials, the Parker Hannifin Corporation is currently developing the newest generation of the device. The trials are designed to support submission for FDA approval, Craig says.
Craig notes that the Indego will be available starting July 2014 at The PEAK Center at Craig Hospital.
Engineered to provide paraplegia patients a “new level of independence,” the Indego is a robotic exoskeleton or powered orthotic device designed to allow users to stand and walk. A news release from Craig Hospital states that Parker has formalized agreements with Craig, as well as the Rehabilitation Institute of Chicago, Kessler Foundation/Kessler Institute for Rehabilitation, West Orange, NJ, and Rusk Rehabilitation at NYU Langone Medical Center, New York, NY.
The release notes that the institutions will coordinate with Shepherd Center in Atlanta, which will continue as Parker’s lead rehabilitation center for the device’s clinical testing. The studies, the release says, are intended to build a body of evidence that demonstrates the safety of Indego required for FDA approval.
Achilleas Dorotheou, head of the human motion and control business unit for Parker, explains that the company has engaged in “discussions with the FDA, payors, 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.”
According to the release, Parker has been in discussion with the FDA during the past year to determine the appropriate classification of the device and obtain input for the design of the clinical trials.
The company adds in the release that it hopes to make the exoskeleton available for commercial launch in 2016.
[Source(s): Craig Hospital, Parker Hannifin]