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– By Conor Hale – Jun 13, 2022 –
To help multiple sclerosis patients who have trouble walking, Ekso Bionics is taking a leap forward with the first FDA clearance in the condition for a robotic exoskeleton suit that provides power and balance to the legs.
Previously cleared in the U.S. and Europe for assisting people with brain and spinal cord injuries, as well as those recovering from a stroke, the company’s EksoNR is designed to be used as part of a rehabilitation program. It helps the wearer stand up out of a wheelchair and learn to walk again.
The FDA’s latest 510(k) green light expands the suit’s reach to more patients, as Ekso estimates nearly 1 million people in the U.S. and as many as 2.8 million globally have been diagnosed with MS. By reinforcing the hips, knees and ankles to help support a natural walking gait, the device aims to enable extended, inpatient therapy sessions without fatigue.
The system has been in use at more than 375 rehabilitation centers worldwide and has accounted for more than 200 million powered steps, according to Ekso.
The FDA first OK’d EksoNR in 2016 for stroke and spinal cord injury rehabilitation. It garnered a second clearance in 2020 for acquired brain injuries including from trauma or damage resulting from an aneurysm, brain tumor, loss of oxygen or other conditions.
In the future, the company says it is considering indications in cerebral palsy and Parkinson’s disease as well as in orthopedics and recovery after surgery in addition to expanding into outpatient rehabilitation centers.
