NeuroPace, Inc. announced that its RNS® System has received FDA approval of MRI labeling for the RNS System, 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.”