RNS® System - P100026
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: RNS® System
PMA Applicant: NeuroPace, Inc.
Address: 1375 Shorebird Way, Mountain View, California 94043
Approval Date: November 14, 2013
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf10/p100026a.pdf
What is it? The RNS System helps reduce the frequency of seizures in epilepsy patients who have frequent, disabling, partial-onset seizures and have not responded well to medications. It consists of a stimulator implanted in the skull under the scalp and leads implanted in the brain.
How does it work? The RNS System senses and records brain electrical activity, and delivers electrical stimulation where the seizures are suspected to originate. The RNS System is intended to interrupt brain activity before the patient experiences clinical seizures.
When is it used? The RNS System is used in conjunction with drugs in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing to identify up to two areas of the brain where seizures originate and have not responded to two or more antiepileptic medications. The RNS System is used in patients who average three or more disabling seizures per month. It has not been evaluated in patients with less frequent seizures.
What will it accomplish? The RNS System reduces the frequency of seizures. The clinical study demonstrated that patients with the device turned on experienced a 38 percent reduction in the average number of seizures per month, compared to a 17 percent reduction in patients who had the device turned off.
When should it not be used? Patients with the RNS System cannot have the following procedures. The energy created from these procedures can be sent through the stimulator and cause permanent brain damage, even if the device is turned off.
- Magnetic Resonance Imaging (MRI)
- Electroconvulsive Therapy (ECT)
- Transcranial Magnetic Stimulation (TMS)
- Diathermy procedures
The RNS System also cannot be used in patients who have:
- a high risk for surgical complications.
- medical devices implanted that deliver electrical energy to the brain, and
- who are unable, or do not have the necessary assistance, to operate the device.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available.