Parker Hannifin Corp said today it won FDA clearance for its Indego exosekelton designed to allow patients with spinal cord injuries to stand and walk for both clinical and personal use.
The Cleveland, Ohio-based company said the approval came based on the largest exoskeleton clinical trial conducted to date in the U.S. The Indego is a robotic exoskeleton powered orthotic device that allows users to stand and walk intended to aid individuals with paraplegia.
“For individuals who sustain spinal cord injuries, this is a milestone that could have a meaningful impact on their lives. In a relatively short amount of time, we have taken what was a prototype device and readied it for full commercial launch. We are excited about the future for this new growth opportunity,” CEO Tom Williams said in a press release.
The Indego exoskeleton is available in Europe as it won CE Mark approval in the European Union in November last year, and a U.S. commercial launch of the device is planned for the coming months, the company said.
“This is an exciting development that will allow Indego to be more widely available. With the regulatory barriers addressed, we look forward to a full commercial launch of the device and further studies that will provide evidence of the economic and health benefits of exoskeleton technology,” Parker human motion and control biz head Achilleas Dorotheou said in prepared remarks.
Parker said last year it agreed to supply Indego devices for a 4-year U.S. Department of Defense-funded study of the economic and rehab beneftis of exoskeletons at 3 rehabilitation centers in the U.S.
“In sponsoring such a comprehensive and landmark study, Parker demonstrated the safety and performance of the Indego technology. Over the course of more than 1,200 individual sessions, study participants were able to use Indego to safely walk on a variety of indoor and outdoor surfaces and settings with no serious adverse events,” Shepherd Center CEO Gary Ulicny said in a prepared statement.