Craig Hospital is among four leading rehabilitation centers participating in a clinical trial for the Indego® exoskeleton. Parker Hannifin Corporation is currently developing the newest generation of the device in preparation for the clinical trials beginning in July, to support submission for FDA approval.
Indego® is a robotic exoskeleton or powered orthotic device that allows users to stand and walk. It is designed to allow people with paraplegia a new level of independence.
Parker has formalized agreements with Craig Hospital, as well as Rehabilitation Institute of Chicago; Kessler Foundation/Kessler Institute for Rehabilitation in West Orange, N.J.; Rusk Rehabilitation at NYU Langone Medical Center in New York, N.Y. These institutions will work in concert with Shepherd Center in Atlanta, Ga., which will continue as Parker’s lead rehabilitation center for clinical testing of the device. Each of these institutions is currently ranked in the top ten U.S. rehabilitation centers by U.S. News & World Report. These studies will build a body of evidence that demonstrates the safety of Indego required for FDA approval.
“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,” said Achilleas Dorotheou, head of the human motion and control business unit for Parker. “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.”
Parker aims at having Indego become the first powered exoskeleton or powered orthotic device to receive FDA clearance. The company has been in discussion with the FDA during the past year to determine the appropriate classification of the device and obtain input into the design of the clinical trials.
Indego® will be available in The PEAK Center at Craig Hospital starting July 2014. The company hopes to make the exoskeleton available for a commercial launch in 2016. Indego is currently an investigational device and limited by law for investigational use only.
To learn more about Indego, visit www.indego.com.
With annual sales of $13 billion in fiscal year 2013, Parker Hannifin is the world’s leading diversified manufacturer of motion and control technologies and systems, providing precision-engineered solutions for a wide variety of mobile, industrial and aerospace markets. The company employs approximately 58,000 people in 49 countries around the world. For more information, visit the company’s web site at www.parker.com.