FDA Approves Novel Device for Upper Limb Rehabilitation After Stroke

The Food and Drug Administration (FDA) has approved the marketing of the IpsiHand Rehabilitation System (IpsiHand System) for Neurolutions for use in patients 18 years of age and older undergoing stroke rehabilitation to facilitate muscle retraining and to increase or increase range of movement .

The IpsiHand System is a brain-computer interface device that assists stroke patients with rehabilitation of the upper extremities including the hand, wrist and arm. The device records brain activity with non-invasive electroencephalography (EEG) electrodes. EEG data is wirelessly transmitted to a tablet for analysis of the intended motor function. A signal is then sent to a wireless electronic hand orthosis to move the patient’s hand. The device can only be obtained with a prescription and may be used as part of rehabilitation therapy.

The FDA approval was based on safety and efficacy data from a non-blind 12-week clinical trial that included 40 patients. The results showed that all patients achieved an improvement in motor skills using the device. Adverse events reported during the study included mild fatigue, discomfort, and transient skin redness.

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“Today’s approval provides an additional treatment option for certain chronic stroke patients undergoing stroke rehabilitation to regain movement of their hands and arms, and addresses an unmet need for patients who may not have access to in-home stroke rehabilitation technology,” said Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health.

Use of the IpsiHand System on patients with severe spasticity or rigid contractures of the wrist and / or fingers is not recommended as it may result in the electronic hand orthosis not being properly seated or positioned for use. In addition, the device should not be used by patients with skull defects due to a craniotomy or craniectomy.

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The FDA approves the marketing of devices to facilitate muscle rehabilitation in stroke patients. [press release]. Silver Spring, MD: US Food and Drug Administration; April 23, 2021.

This article originally appeared on MPR


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