FDA has authorized the Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) for stroke survivors trying to regain hand, wrist, or arm function.
The IpsiHand System may be prescribed to stroke patients wishing to improve grasping as part of their rehabilitation therapy. The brain-computer-interface device uses non-invasive electroencephalography electrodes to record a person's brain activity, and then moves an electronic hand brace according to the intended muscle movement.
"Thousands of stroke survivors require rehabilitation each year," said Christopher Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices at the FDA, in a statement. "Today's authorization offers certain chronic stroke patients undergoing stroke rehabilitation an additional treatment option to help them move their hands and arms again and fills an unmet need for patients who may not have access to home-based stroke rehabilitation technologies."
Approval was based on a 40-person unblinded study in which all participants showed motor function improvement with the device over 12 weeks. Adverse events reported in the study included minor fatigue, discomfort, and temporary skin redness.
The IpsiHand System had been granted breakthrough device designation by the FDA and was authorized for marketing through the de novo premarket review pathway.
The device should not be used by patients who cannot be properly fitted for the electronic hand brace, nor those with skull defects due to craniotomy or craniectomy, the FDA cautioned.
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April 24, 2021 at 12:17AM
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