FDA OKs Neurolutions’ IpsiHand System for Stroke Rehabilitation

The U.S. Food and Drug Administration authorized marketing of Neurolutions Inc.’s Neurolutions IpsiHand Upper Extremity Rehabilitation System, which is indicated for use in patients 18 and older undergoing stroke rehab to facilitate muscle re-education and for maintaining or increasing range of motion. The IpsiHand System is a brain-computer-interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity disability.
 
“Thousands of stroke survivors require rehabilitation each year. 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,” Christopher M. Loftus, M.D., acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health told the press.
 
Post-stroke rehabilitation helps individuals overcome disabilities that result from stroke damage. The IpsiHand System uses non-invasive electroencephalography (EEG) electrodes instead of using an implanted electrode or other invasive feature to record brain activity. The EEG data is then wirelessly conveyed to a tablet for analysis of the intended muscle movement (intended motor function) and a signal is sent to a wireless electronic hand brace, which in turn moves the patient’s hand. The device aims to help stroke patients improve grasping. The device is prescription-only and may be used as part of rehabilitation therapy.
 
The FDA assessed safety and effectiveness through clinical data submitted by the company, including an unblinded study of 40 patients over a 12-week trial. All participants demonstrated motor function improvement with the device over the trial. Adverse events reported included minor fatigue and discomfort and temporary skin redness.
 
The IpsiHand System device 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 fit or positioned for use or those with skull defects due to craniotomy or craniectomy.
 
The IpsiHand System device was granted Breakthrough Device designation, which is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The FDA reviewed the IpsiHand System device through the De Novo premarket review pathway.