Indego® Exoskeleton Receives U.S. Regulatory Clearance for Stroke Treatment
Indego becomes the broadest available exoskeleton in the U.S. for gait therapy and personal use; clearance greatly expands the number of potential patients who can use exoskeletons
CLEVELAND, Feb. 15, 2018 (GLOBE NEWSWIRE) -- Parker Hannifin Corporation, the global leader in motion and control technologies, today announced that the U.S. Food and Drug Administration (FDA) has given additional clearance to market and sell the Indego exoskeleton for use in the treatment of individuals with hemiplegia 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 stroke patients 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 suffer 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 U.S., where a broad range of stroke patients received gait therapy with Indego and its therapy software suite.
“With the Therapy+ Software Suite, Indego can be used to provide individualized and patient-centric training, which is of critical importance for successful gait therapy sessions with stroke patients,” said Dr. Karen Nolan from the Kessler Foundation, one of the clinical trial centers.
Indego is a state-of-the-art rehabilitation and assistive technology designed to improve patient mobility and independence while offering clinicians a meaningful therapy tool. Indego has received FDA Clearance and CE Mark, allowing it to be sold commercially in the U.S. and Europe. Indego has also earned a UL Mark which was obtained through extensive testing to certify the high standards of the Indego system design, function, and safety. To learn more about Indego visit www.indego.com
About Parker Hannifin
Parker Hannifin is a Fortune 250 global leader in motion and control technologies. For 100 years the company has engineered the success of its customers in a wide range of diversified industrial and aerospace markets. Learn more at www.parker.com or @parkerhannifin.
Parker Hannifin Media
Aidan Gormley, Director, Global Communications and Branding, 216/896-3258, firstname.lastname@example.org
Kessler Foundation Media
Carolann Murphy, PA; 973-324-8382; CMurphy@KesslerFoundation.org
Laura Viglione, MS; 973-323-3675; LViglione@KesslerFoundation.org