The US Food and Drug Administration (FDA) has approved the IpsiHand Upper Extremity Rehabilitation System (IpsiHand System), a noninvasive device that uses a brain-computer interface to help stroke patients recover use of their hands and arms.
This 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,” Christopher M. Loftus, MD, acting director, Office of Neurological and Physical Medicine Devices, the Center for Devices and Radiological Health, FDA, said in an agency statement.
The IpsiHand System includes a movable brace that fits over the paralyzed hand and a head cap fitted with electrodes that provide electroencephalography (EEG) data. The EEG data are wirelessly sent to a tablet for analysis of the intended motor function, and a signal is sent to the brace, which in turn moves the patient’s hand so as to improve grasping.
The IpsiHand System is a prescription-only device intended for use in the clinic or in the home as part of a stroke patient’s prescribed rehabilitation therapy.
In approving the device, the FDA reviewed safety and effectiveness data submitted by the company, including data from an unblinded study of 40 patients who took part in a 12-week trial. All participants showed improvement in motor function after using the device.
Reported adverse events included minor fatigue and discomfort and temporary skin redness.
The FDA says the IpsiHand system should not be used by patients with severe spasticity or rigid contractures in the wrist and/or fingers that would prevent the electronic hand brace from being properly fitted or positioned for use, nor should it be used by those with skull defects due to craniotomy or craniectomy.
The IpsiHand System received breakthrough device designation and was approved under the de novo premarket review pathway for new low- to moderate-risk devices.
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