Neurolutions has secured authorisation from the US Food and Drug Administration (FDA) for its IpsiHand upper extremity rehabilitation system (IpsiHand system) to facilitate muscle rehabilitation in stroke patients.
The new device has been developed for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education, as well as for maintaining or increasing range of motion.
The IpsiHand system is a brain-computer-interface (BCI) device, which helps in rehabilitation for stroke patients with upper extremity or hand, wrist and arm disability.
As per the Centers for Disease Control and Prevention, someone in the US has a stroke every 40 seconds and around 795,000 people in the US have a stroke each year.
IpsiHand system’s safety and efficacy were evaluated by the FDA via clinical data submitted by Neurolutions. It also included data from an unblinded study of 40 patients over a 12-week trial.
According to the company, all participants showed motor function improvement with the device over the trial.
The FDA’s Centre for Devices and Radiological Health’s neurological and physical medicine devices office acting director Dr Christopher Loftus said: “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.”
In place of an implanted electrode or other invasive feature, the IpsiHand System uses non-invasive electroencephalography (EEG) electrodes to record brain activity.
For analysis of the intended muscle movement, the EEG data is wirelessly sent to a tablet and a signal is sent to a wireless electronic hand brace, which in turn moves the patient’s hand.
The device is designed to help stroke patients improve grasping.
The FDA has granted breakthrough device designation for the IpsiHand system, which is prescription-only and may be used as part of rehabilitation therapy.
