FDA has authorized a breakthrough device for patients 18 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 is a brain-computer interface (BCI) device designed to assist in rehabilitation for stroke patients with upper extremity (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,” said Christopher M. Loftus, MD, acting director of the Office of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health.
A stroke occurs when normal blood flow to the brain is interrupted. Brain cells obtain oxygen and nutrients from regular blood circulation, so when there is a blockage of blood flow to the brain caused by a clot (an ischemic stroke) or excessive bleeding in the brain due to a ruptured blood vessel (a hemorrhagic stroke), the brain cells can die from a lack of blood and oxygen. 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. According to the Centers for Disease Control and Prevention, someone in the United States has a stroke every 40 seconds. That equates to about 795,000 U.S. stroke victims a year.
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 approval of the IpsiHand System represents an important step forward in the care and rehabilitation of stroke patients,” said Neurolutions CEO Leo Petrossian, PhD. “For the first time, we are able to combine advanced robotics with brain computer interface technology to augment traditional stroke rehabilitation, allowing patients to improve upper extremity function after stroke.”
The Neurolutions IpsiHand System is designed for home or clinic use as part of prescribed stroke rehabilitation therapy. IpsiHand includes a wearable robotic exoskeleton that is worn over the patient’s hand and wrist, a tablet computer, and an EEG-based biometric headset. The system translates brain signals from the uninjured, or ipsilateral, hemisphere of the brain, into movement of the exoskeleton. As a result, when the patient thinks about opening their hand, the device physically opens the patient’s impaired hand. This ability to physically open and close the patient’s hand based on the patient’s thoughts facilitates muscle re-education, improving upper extremity rehabilitation, the company said. Developed by a team of innovators in Silicon Valley and neuroscientists from Washington University in St. Louis, MO, the neuro-prosthetic and robotic capabilities of the IpsiHand System have been shown in clinical trials to provide both statistically and clinically significant outcomes for chronic stroke patients.
“The IpsiHand System represents the cutting-edge of medical technology and is the first FDA-authorized brain-computer interface for robotic rehabilitation,” said Kern Bhugra, chief operating officer of Neurolutions. “This milestone would never have been possible without partnership with the FDA, who diligently worked with us to ensure we brought this benefit to patients.”
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.
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, 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 FDA’s 510(k) premarket process, whereby devices can obtain clearance by demonstrating substantial equivalence to a predicate device.
The IpsiHand device received breakthrough device designation from FDA as well. The breakthrough designation 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 designation may also streamline the process required for Medicare reimbursement.