The FDA review panel has just recommended that Medtronic’s Deep Brain Stimulation be approved for treatment of epilepsy.
According to the Minneapolis Star Tribune, the review panel was made up of neurological experts, who voted 7 to 5 on the device. The review panel has recommended that the Food and Drug Administration (FDA) approve the product, Activa, for epilepsy. Therefore, there is still a chance that the product will not be approved for public use; however, they generally follow the panel’s advice.
The product is already approved for other movement disorders, including Parkinson’s Disease. In addition, the product has been implanted in 6,000 patients in the U.S. in the past decade.
The panel recommended that the product include warnings about memory loss and/or depression. They also recommended that Medtronic monitor patient safety for five years after implantation.
For more information on the FDA panel’s recommendation of Medtronic’s Deep Brain Stimulator, click on the links below: