Mountain View-based 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.
Because MRI scans are often used to monitor patients with brain anomalies that may contribute to seizures, incompatibility with the imaging modality may have precluded some patients from receiving treatment with the RNS System. In addition, patients who require regular MRI scans for non-brain conditions may now also consider the RNS System as a treatment option for their seizures.
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.
“MRI conditional labeling opens up valuable medical imaging possibilities for our patients treated with the model RNS-320 neurostimulator, who can now receive full-body 1.5T magnetic resonance imaging (MRI) scans under appropriate conditions,” said Michael Favet, President and CEO of NeuroPace, in the announcement. “I’m pleased that we have removed a potential barrier to treatment and increased the number of patients who can benefit from this life-changing therapy.”
Check out a video of how the RNS System works:
Flashbacks: NeuroPace Epileptic Seizure Control System: Interview with Dr. Martha Morrell, CMO of NeuroPace; NeuroPace Seeks FDA Approval for Its RNS System; NeuroPace Gets FDA Pre-Market Approval for RNS Stimulator; Neuropace Implantable Epilepsy Device Showing Positive Signs in Initial Clinical Study; NeuroPace: Maybe First Since Jesus to Prevent and Treat Epilepsy
Product page: NeuroPace RNS…