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Ekso Bionics announced today that it received FDA clearance for its Ekso GT robotic exoskeleton to be used for the treatment of hemiplegia caused by stroke and for certain types of spinal cord injuries.
The wearable robotic system enables patients to walk with full weight bearing and reciprocal gait. When it's paired with the company's Variable Assist software, it provides adaptive power to either side of the patient's body.
When the Ekso GT was introduced in 2012, exoskeleton technology was relatively new and did not yet have a specific category defined by the FDA, according Thomas Looby, president and CEO of Ekso Bionics. Since then, the FDA has assigned a new category for powered exoskeletons.
"Being able to not only secure the same clearance as the predicate devices but being able to additionally secure clearance for higher SCI injury levels as well as stroke serves to validate our growing industry, and demonstrates a trend toward becoming standard of care," Looby told HCB News.
In the U.S. there are about 12,500 new cases of spinal cord injuries every year, according to the National Spinal Cord Injury Statistical Center. More than 60 percent of acute stroke survivors are unable to walk or require interventions to help them walk.
One of Ekso Bionics' goal is to make exoskeletons a standard of care in rehabilitation clinics. Their strategy is to focus on this care setting by concentrating on the ease of use of the exoskeleton, ensuring quick turnover between sessions and providing care for a variety of patients.
Clinics that use the Ekso GT are able to treat a wide patient population, which the company claims sets it apart from other exoskeletons on the market. To date, the exoskeleton has helped patients from over 115 rehabilitation clinics around world take more than 41 million steps.
The Rehabilitation Institute of Chicago partnered with Ekso Bionics at the start of 2012 and received its first Ekso GT exoskeleton. The institute reports that it has seen the clinical value of the technology already.
