FDA Approves MRI Labeling for NeuroPace RNS System

March 10, 2020

The label expansion now allows patients who require non-brain MRI monitoring to receive treatment with the stimulation device.

Michael Favet

The FDA has approved a labeling update for NeuroPace’s responsive neurostimulation (RNS) system, allowing treatment for patients with non-brain MRI requirements and individuals with focal onset seizures that require monitoring for brain anomalies, such as tuberous sclerosis complex, brain tumors, or multiple sclerosis.1

“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. 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,” said Michael Favet, president and CEO of NeuroPace, in a statement.

The FDA’s decision was based off a real-world study that showed an 82% median seizure frequency reduction at 3 years, with 1 in every 3 patients achieving 90% or greater seizure reduction.1

At the 2019 American Epilepsy Society (AES) annual meeting, December 6-10, 2019, NeuroPace announced 1-year interim findings of its 5-year, postapproval study, citing the RNS system’s safe and effective profile in treating medically intractable focal seizures.2

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Originally approved in 2013 for the treatment of medical refractory epilepsy, interim results from the long-term study showed a 68% median seizure frequency reduction with the neurostimulation device at 1 year compared to 44% in the pivotal trial.2

The latest approval of MRI labeling for the RNS system may add an additional treatment option to the antiseizure armamentarium for those with refractory epilepsy who were previously restricted by the need for necessary imaging.

The RNS system is designed to prevent seizures using a neurostimulator, leads placed at the seizure foci, a remote monitor for uploading data, and an RNS tablet and patient data management system. NeuroPace claims that the RNS system is the only epilepsy treatment that enables clinicians to personalize and optimize therapy using captured direct, real-world, electroencephalogram data.

“The approval decision is wonderful news for the many people living with refractory epilepsy. This therapy not only reduces seizures, it also empower clinicians with data-driven insights into their patients’ epilepsy,” said David Burdette, MD, section chief of epilepsy at Spectrum Health Medical Group, said in a statement.

REFERENCES:

1. NeuroPace RNS system receives FDA approval for MRI labeling, allowing thousands more patients to benefit from personalized, data-driven epilepsy treatment [news release]. Mountain View, CA: NeuroPace. neuropace.com/neuropace-rns-system-fda-approval-mri-labeling/. March 9, 2020. Accessed March 10, 2020.

2. Szaflarski JP, Morrell MJ. Interim Safety and Effectiveness Outcomes from a Prospective Post-Approval Trial of the RNS System. Presented at: American Epilepsy Society 2019 Meeting; December 7—10; Baltimore, Maryland. Abstract 1.228.