The device is comprised of a small neurostimulator that is implanted in the skull under the skin and two electrodes placed on or near the part of the brain where the patient’s seizures arise.
“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,” said Christy Foreman, Director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, in a November 2013 press release.
“The FDA approval of the Neuropace RNS system provides a new treatment option for patients with some types of epilepsy that are not well controlled with medications,” said Dr. Guy McKhann from the Epilepsy Center at Columbia University Medical Center. “We at Columbia have been part of the device development and testing since the inception of Neuropace as a company. The former head of the Columbia Comprehensive Epilepsy Center, Martha Morrell M.D., is the current Chief Medical Officer at Neuropace. We are happy to be able to offer this novel surgical treatment to our epilepsy patients, knowing that our more than ten years of experience will give them the best possible chance of safe and effective treatment.”
The FDA approval is based on clinical trials which reported, “Twenty nine percent of patients with an active device experienced at least a fifty percent reduction in the overall number of seizures.” A further reduction in seizure frequency was demonstrated in a two year follow-up study.
To learn more about the Neuropace RNS Stimulator, read the FDA press release here.
You have added pages to your clipboard. Please log in or create an account to share them or use later.
You are now being taken to Columbia Neurosurgery's site dedicated to the spine.
Use this button to save pages to your clipboard for future use.OK. Got it.