FDA Approves Indego® Exoskeleton for Stroke Rehabilitation and Treatment
State-of-the-art device tested at Shepherd Center allows people with paralysis due to stroke to stand and walk.
Parker Hannifin Corporation, the global leader in motion and control technologies, has announced that the U.S. Food and Drug Administration (FDA) recently gave additional clearance to market and sell the Indego® exoskeleton for use in the rehabilitation and treatment of individuals with paralysis on one side of the body due to stroke. By expanding on its original clearance for individuals with a spinal cord injury, this announcement makes Indego the most broadly available exoskeleton for gait therapy and personal use in the United States.
“We are excited that Indego is now available for a much larger number of patients in the United States, enabling persons with stroke to have access to this novel gait therapy,” said Achilleas Dorotheou, head of the human motion and control business unit for Parker.
The American Heart Association estimates that 795,000 Americans experience a stroke every year and report that stroke is the leading cause of long-term disability in the country. Assistance with ambulation in a clinical environment may aid in the recovery of gait impairments, which is one of the most desired goals for stroke survivors undergoing rehabilitation.
The recent FDA clearance came after the completion of a large, multi-site clinical trial involving eight rehabilitation centers in the United States, including Shepherd Center, where a broad range of people with stroke received gait training with Indego. Results of the study showed improvements in step symmetry and a reduction in gait deviations. Shepherd Center serves as Parker Hannifin’s lead clinical partner.
“The expanded FDA approval of Indego is very exciting, and Shepherd Center’s research team is eager to incorporate Indego technology across a broader spectrum of patients for clinical use,” said Clare Hartigan, PT, MPT, research project manager. “Our research team would like to thank all the patients who so graciously gave their time to help guide the development of the device for this new patient population.”
Shepherd Center’s research with Indego will continue with individuals with spinal cord injury,stroke and potentially other diagnoses. To be considered for participation in any upcoming study with Indego, please register using our clinical trials intake form here.
For more information on Indego, visit indego.com.
Shepherd Center, located in Atlanta, Georgia, is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury, brain injury, multiple sclerosis, spine and chronic pain, and other neurological conditions. Founded in 1975, Shepherd Center is ranked by U.S. News & World Report among the top 10 rehabilitation hospitals in the nation. In its more than four decades, Shepherd Center has grown from a six-bed rehabilitation unit to a world-renowned, 152-bed hospital that treats more than 740 inpatients, nearly 280 day program patients and more than 7,100 outpatients each year in more than 46,000 visits.