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FDA Clears Novel Device for Upper Extremity Rehabilitation After Stroke

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The Food and Drug Administration (FDA) has authorized marketing of the Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) device for use in patients 18 years of age and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion.

The IpsiHand System is a Brain-Computer-Interface device that helps stroke patients in the rehabilitation of the upper extremities including the hand, wrist, and arm. The device records brain activity using non-invasive electroencephalography (EEG) electrodes; EEG data are wirelessly transmitted to a tablet for analysis of the intended motor function. A signal is then sent to a wireless electronic hand brace to move the patient’s hand. The device is available only with a prescription and may be used as part of rehabilitation therapy.

The FDA authorization was based on safety and efficacy data from an unblinded 12-week clinical study that included 40 patients. Results demonstrated that all patients achieved motor function improvement when using the device. Adverse events reported during the study included minor fatigue, discomfort, and temporary skin redness.

“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,” said Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health.  

Use of the IpsiHand System by patients with severe spasticity or rigid contractures in the wrist and/or fingers is not recommended as this may prevent the electronic hand brace from being properly fit or positioned for use. Additionally, the device should not be used by patients with skull defects due to craniotomy or craniectomy.

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Schedule22 Jan 2022
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