Approved: Post-Stroke Muscle Rehab Device

FDA approves IpsiHand System for post-stroke patients

(RxWiki News) A device to help post-stroke patients with muscle re-education has received approval from the US Food and Drug Administration (FDA).

This new device is called the Neurolutions IpsiHand Upper Extremity Rehabilitation System (IpsiHand System). The FDA approved it for adults who are undergoing rehab for a stroke.

After a stroke, individuals may find their arm, hand and wrist movements to be difficult. This device is meant to help with that.

"Thousands of stroke survivors require rehabilitation each year," said Dr. Christopher M. Loftus, acting director of the FDA's Office of Neurological and Physical Medicine Devices, in a press release. "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."

A stroke happens when blood flow to the brain is blocked. Every 40 seconds, someone in the United States has a stroke, according to the Centers for Disease Control and Prevention (CDC).

After a stroke, rehabilitation is often required to help with disabilities that are a result of the stroke.

Considered non-invasive, the IpsiHand System can be used as part of rehabilitation therapy. It requires a prescription.

The IpsiHand System focuses on helping patients improve grasping. This device uses electroencephalography (EEG) electrodes to record brain activity. It then sends the brain activity data to a tablet to determine what muscle movement is desired. Then, a signal goes to a wireless electronic hand brace, which will then move the patient's hand.

This device was studied in over 40 patients over 12 weeks. Possible adverse events included minor fatigue and discomfort, as well as temporary skin redness.

This device is not recommended in those with severe spasticity or rigidness in which the brace can't be properly positioned, the FDA noted.

The approval for this device was granted to Neurolutions, Inc.