NeuroPace RNS System for Epilepsy Gets FDA Approval for MRI Labeling

NeuroPace today announced it has received FDA approval for MRI labeling for its RNS System, a closed-loop brain-responsive neurostimulation system designed to prevent seizures in adults refractory to antiseizure medications. The approval applies specifically to the RNS-320 model of the RNS neurostimulator.

Individuals with focal onset seizures that also have brain anomalies that require monitoring, such as tuberous sclerosis, brain tumors or multiple sclerosis, as well as those with non-brain MRI requirements, can now be offered the RNS System as a treatment option. This will also allow people to receive the RNS System before committing to an irreversible surgery such as laser ablation, while keeping their future treatment options open.

The RNS System is designed to prevent seizures at their source, according to the company. The device itself is implanted with a procedure performed by a neurosurgeon, and consists of leads that are placed at the seizure source and a neurostimulator placed under the scalp. The RNS System also includes a remote monitor that wirelessly collects information from the neurostimulator and transfers it to a patient data management system, where physicians may view seizure activity and therapy progress.

Treatment with the RNS System has been shown in a multi-center retrospective study to produce a median seizure frequency reduction of 82% at 3 years, with 1 in 3 patients achieving 90% or greater seizure reduction, according to the company’s press release. In addition to therapeutic benefits, the RNS System is the only epilepsy treatment that captures direct, real-world EEG data, enabling clinicians to personalize and optimize therapy over time.

About the RNS® System

The RNS System is the world’s only closed-loop brain-responsive neurostimulation system designed to prevent seizures at their source. The RNS System is composed of a neurostimulator, leads that are placed at the seizure foci, a remote monitor used by patients to upload their data, and an RNS Tablet and Patient Data Management System (PDMS) used by physicians. Physicians can view their patient’s EEG data on a secure website and program the device to personalize therapy for each individual. Unlike anti-epileptic drugs or resective surgery, brain-responsive neuromodulation outcomes typically improve with time and do not cause the cognitive side effects that can be associated with those alternatives. The RNS System is now available at nearly all comprehensive epilepsy centers in the United States and is widely covered by private and government insurance.

The RNS System is an adjunctive therapy for adults with refractory, focal onset seizures with no more than 2 epileptogenic foci. See important safety information at https://www.neuropace.com/safety/.