The U.S. Food and Drug Administration has authorized the marketing of the IpsiHand, a new device indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion.

The IpsiHand Upper Extremity Rehabilitation System (IpsiHand System), from Neurolutions Inc, is a Brain-Computer-Interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity—or hand, wrist and arm—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, MD, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health

Designed for Post-Stroke Rehab

Although stroke is a brain disease, it can affect the entire body and sometimes causes long-term disability such as complete paralysis of one side of the body (hemiplegia) or one-sided weakness (hemiparesis) of the body. Stroke survivors may have problems with the simplest of daily activities, including speaking, walking, dressing, eating and using the bathroom.

Post-stroke rehabilitation helps individuals overcome disabilities that result from stroke damage. The IpsiHand System uses non-invasive electroencephalography (EEG) electrodes instead of 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.

Assessment Study

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.

Breakthrough Device

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, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.

This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket process, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.

The FDA granted marketing authorization of the Neurolutions IpsiHand Upper Extremity Rehabilitation System to Neurolutions Inc.

[Source(s): US Food and Drug Administration, PR Newswire]

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