FDA Approves Neuropace’s Implantable Neurostimulator for Treatment-Resistant Epilepsy

The US Food and Drug Administration announced that it has approved California-based Neuropace Inc's implantable neurostimulator for reducing the number of seizures in epilepsy patients who have not responded well to medications.

Known as the RNS Stimulator, the device can be implanted within the skull under the scalp and is connected to electrodes that are placed where the seizures are suspected to originate within the brain.

Neuropace conducted a randomized trial involving 191 patients over a period of three-months after which it found that the device was able to cut down the number of seizures by 38 percent per month.

"The neurostimulator detects abnormal electrical activity in the brain and responds by delivering electrical stimulation intended to normalize brain activity before the patient experiences seizure symptoms", the director of the Office of Device Evaluation in the FDA's Center for Devices and Radiological Health, Christy Foreman said.

Source: Medindia