FDA Clears EksoNR Robotic Exoskeleton for Rehabilitation in Multiple Sclerosis

After previously being approved for use in the stroke and acquired brain injury populations, the Ekso Bionics product now becomes the first such device approved in the multiple sclerosis patient population.

The FDA has granted 501(k) clearance to the EksoNR robotic exoskeleton for use with patients with multiple sclerosis (MS), making it the first such device to be approved for rehabilitation efforts in MS.1

Previously, in June 2020, the EksoNR robotic exoskeleton was approved for use in those with acquired brain injury and in April 2016 for the rehabilitation of patients with stroke and traumatic brain injury, becoming the first exoskeleton device for both indications.2,3

"The studies used for the FDA submission demonstrated that the participants demonstrated both improvements and gait speed and balance. People who have MS often have fatigue and endurance impairments. EksoNR can help reduce fatigue and improve endurance and activity tolerance," Michael Glover, PT, NCS, global director of clinical experience, Ekso Bionics, told NeurologyLive®. "EksoNR also provides postural support and offers a carry-over effect to core strength, as well as offers spasticity management. Lastly, there are cognition and psychological benefits. The improvements in functional activity and mobility offer hope for disease management."

As MS often results in fatigue and difficulties with walking, the exoskeleton offers an option for the rehabilitative portion of care for these patients. The exoskeleton is also approved for use in Europe, and according to Esko has been utilized in more than 375 rehabilitation centers around the globe to date.

“As a leader in early-to-market wearable robotic solutions for medical rehabilitation, we are committed to maximizing patient access to our technology,” Steven Sherman, chairman and chief executive officer, Ekso Bionics, said in a statement.1 “With the indications for use now expanded to include MS, the EksoNR has the potential to assist significantly more patients and improve patient mobility. We are excited to see the device benefit MS patients, providing critically needed rehabilitation solutions just as it has for patients suffering from stroke, spinal cord injury, and acquired brain injury.”

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Four studies for the EksoNR robotic exoskeleton are currently recruiting or being initiated. Two that are not yet recruiting include one being conducted by Vrije Universiteit Brussel (NCT05334030), aiming “to decipher the relationship between EksoNR's robotic control settings and walking biomechanics in stroke patients and healthy subjects,” and “to discover the user experience during the use of EksoNR,” according to clinicaltrials.gov information. The second that is not yet recruiting is being conducted by Alvernia University (NCT05133362) to evaluate the effect of backward gait training with the EksoNR exoskeleton on motor function in those with stroke.

The remaining two that are currently recruiting are also in the stroke population, including one being conducted by the Shirley Ryan AbilityLab (NCT04550039) assessing the exoskeleton compared with a body-weight supported treadmill intervention on contraversive pushing behaviors in those with stroke in an acute inpatient rehabilitation setting. The group, being led by Arun Jayaraman, PT, PhD, will also evaluate their effects on functional mobility, strength, balance, and endurance, as well as therapist burden. The second, called Ekso-FES (NCT05187650) is being led by Mario Widmer, DSc, of the Swiss Paraplegic Centre Nottwil, and will evaluate the exoskeleton in combination with functional electrical stimulation in those with chronic spinal cord injury compared with the exoskeleton alone.

REFERENCES
1. Ekso Bionics Receives FDA Clearance to Market its EksoNR™ Robotic Exoskeleton for Use with Multiple Sclerosis Patients. News release. Ekso Bionics Holdings. June 13, 2022. Accessed June 13, 2022. https://www.globenewswire.com/news-release/2022/06/13/2461153/29945/en/Ekso-Bionics-Receives-FDA-Clearance-to-Market-its-EksoNR-Robotic-Exoskeleton-for-Use-with-Multiple-Sclerosis-Patients.html
2. Ekso Bionics® Receives FDA Clearance to Market its EksoNR™ Robotic Exoskeleton for Use with Acquired Brain Injury Patients. News release. Ekso Bionics Holdings. June 25, 2020. Accessed June 13, 2022. https://ir.eksobionics.com/press-releases/detail/689/ekso-bionics-receives-fda-clearance-to-market-its
3. Ekso GT™ Robotic Exoskeleton Cleared by FDA for Use With Stroke and Spinal Cord Injury Patients. News release. Ekso Bionics Holdings. April 4, 2016. Accessed June 13, 2022. https://ir.eksobionics.com/press-releases/detail/570/ekso-gt-robotic-exoskeletoncleared-by-fda-for-use-with