FDA OKs MRI Labeling for NeuroPace’s RNS System

Neuropace Inc.’s RNS System has received U.S. Food and Drug Administration (FDA) approval of MRI labeling, expanding treatment options for the approximately one million patients in the United States living with seizures that do not respond to medication.
 
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.
 
“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. “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.”
 
“The approval decision is wonderful news for the many people living with refractory epilepsy. This therapy not only reduces seizures, it also empowers clinicians with data-driven insights into their patients’ epilepsy,” said David Burdette, M.D., section chief of epilepsy at Spectrum Health, Grand Rapids, Michigan.
 
Treatment with the RNS System has been shown in a real-world, multi-center retrospective study to deliver outcomes never before seen with any neuromodulation device for epilepsy. Patients saw median seizure frequency reduction of 82 percent at 3 years, and 1 in 3 patients achieved 90 percent or greater seizure reduction.¹ 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.
 
Reference
¹ Lin, et. al. Real-world experience with brain-responsive neurostimulation for focal onset seizures. Poster, AES 2019 (Abst. 1.216)