Indego® Exoskeleton Receives U.S. Regulatory Clearance for Stroke Treatment
February 15 2018 - 8:30AM
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.
About Indego
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 HannifinParker 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.
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Media –
Aidan Gormley, Director, Global Communications and Branding
216/896-3258
aidan.gormley@parker.com
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