FDA Authorises Marketing of Device to Facilitate Muscle Rehabilitation After Stroke

April 24, 2021
The US Food and Drug Administration (FDA) authorised marketing of a new device indicated for use in patients aged 18 years and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. The Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) is a Brain-Computer-Interface device that assists patients with upper extremity disability after stroke. “Thousands of stroke survivors require rehabilitation each year,” said Christopher M. Loftus, MD, FDA’s Center for Devices and Radiological Health, Rockville, Maryland. “Today’s authorisation offers certain patients undergoing rehabilitation for chronic stroke 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.” 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 the safety and effectiveness of the IpsiHand System device 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 granted marketing authorization to Neurolutions, Inc. Reference: https://www.fda.gov/news-events/press-announcements/fda-authorizes-marke... SOURCE: US Food and Drug Administration