The FDA authorized the Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System), a brain-computer-interface device, for use in adult patients to assist with muscle re-education and maintain range of motion in the upper extremities during stroke rehabilitation.
The prescription-only device, which the FDA granted a Breakthrough Device designation, is intended to assist stroke patients improve their grasping ability—it uses non-invasive electroencephalography (EEG) electrodes to record brain activity that is wirelessly sent to a tablet for analysis while a signal is sent to a wireless electronic hand brace to move the patient’s hand.
“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,” 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, in a statement.
“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,” the agency explained. “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 agency noted that the device should not be used by patients with severe spasticity or rigid contractures in their wrist or fingers, as this could prevent the hand brace from being properly fitted or positioned for use. The device should also not be used by patients with skull defects due to craniotomy or craniectomy.
The IpsiHand system is manufactured by Neurolutions, Inc.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 38
Topic ID: 82,38,730,8,38,192,725,925