The Neurolutions IpsiHand Upper Extremity Rehabilitation system is indicated for use in patients with chronic stroke age 18 or older undergoing stroke rehabilitation to facilitate muscle re-education.
Neurolutions has announced that the FDA has granted de novo market authorization, as well as breakthrough device designation, for its IpsiHand Upper Extremity Rehabilitation System to treat patients with chronic stroke.1
The IpsiHand system becomes the first FDA approved, device leveraging brain-computer interface technology to assist patients with chronic stroke in rehabilitation. The device utilizes the uninjured, or ipsilateral, side of the brain to improve arm and hand function and is indicated for patients 18 years and older.
"The approval of the IpsiHand System represents an important step forward in the care and rehabilitation of stroke patients,” Leo Petrossian, PhD, chief executive officer, Neurolutions, said in a statement. “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 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 period. All participants demonstrated motor function improvement with the device over the trial. Adverse events reported included minor fatigue and discomfort and temporary skin redness.
Designed for in-home or clinic use, the IpsiHand system includes a robotic exoskeleton that is worn over the patient’s hand and wrist, an electroencephalogram (EEG)-based headset, and a tablet. The lightweight, adjustable, battery-powered, robotic exoskeleton is designed to physically open and close the patient’s hand in response to the patient’s thoughts.2
A wireless EEG electrode device is worn on the head and used to measure the patient’s brain signals which are then analyzed by the same system to determine the patient’s intent to move their affected hand. Following that, it translates the signals into motor movement of the robotic skeleton, resulting in the aforementioned opening and closing of the impaired hand. The tablet is the interface to the IpsiHand therapy and communicates with the overall system, including the biometric headset and wearable robotic exoskeleton. An application running on the tablet guides the patient through the therapy session and provides for seamless upload of usage and performance data to the cloud.
"Progress in improving rehabilitation outcomes for stroke patients has historically been challenging, but the market authorization of the IpsiHand System promises to usher in a bright future for our stroke patients and allows us to support their recovery throughout the rehabilitation process,” Eric Leuthardt, MD, chief scientific officer, Neurolutions, chief of Division of Neurotechnology and professor of neurosurgery and neuroscience, Washington University, said in a statement.