RNS® System: NeuroPace, Inc. today announced the publication of two seminal studies of the RNS® System in prominent scientific journals Epilepsia and Neurology. The RNS System has been shown to dramatically reduce seizures and improve quality of life for people living with refractory epilepsy.
Real-World Data Demonstrating Unprecedented Efficacy Outcomes with the RNS System Published in Epilepsia
Real-world data from a multicenter clinical study of the RNS System were published in Epilepsia, demonstrating seizure reductions not seen with any other neuromodulation system for refractory focal epilepsy.
Published results from the retrospective study of 150 patients across eight epilepsy centers showed that patients who received the RNS System achieved a one year median seizure frequency reduction of 67% and a two year reduction of 75%. At three or more years, patients experienced an unprecedented 82% median reduction in seizure frequency—the highest reported for any neuromodulation system. One in three patients achieved >90% seizure frequency reduction and nearly 1 in 5 reported being seizure-free in the preceding three months. Physicians reported that 75% of patients who received the RNS System were “much improved” or “very much improved” in their functioning at most recent follow up.
“These real-world outcomes are even better than those reported in the clinical trials supporting FDA approval and underscore the unique advantages of the RNS System for people living with refractory epilepsy,” said Vikram Rao, MD, PhD, one of the two lead authors on the paper. “In addition to compelling therapeutic benefits, the RNS System is the only epilepsy treatment that empowers clinicians with long-term intracranial EEG data, providing them with actionable insights that can be used to develop a personalized treatment plan for each patient.”
Landmark Nine Year Prospective Clinical Trial Results Published in Neurology
Complete results from NeuroPace’s groundbreaking nine-year, multi-center Long-Term Treatment Study were recently published in the July 2020 issue of Neurology, the medical journal of the American Academy of Neurology. The study included 230 patients across 34 epilepsy centers with nearly 1,900 patient-implant years of follow-up. It is the largest prospective neuromodulation trial in the field of epilepsy.
The study authors concluded that the RNS System provides significant and sustained reductions in disabling seizures with enduring improvements in quality of life. At nine years, the median percent reduction in seizure frequency was 75% (p<0.0001) and 73% of patients in the study experienced at least a 50% reduction in seizures. Enduring improvements were seen in overall quality of life (QOL) and cognitive function (p<0.05), areas often profoundly impacted in individuals living with epilepsy. Responsive neurostimulation was well-tolerated and safe over time, with a surgical safety profile similar to other epilepsy procedures and no serious adverse events related to stimulation. The sudden unexplained death in epilepsy (SUDEP) rate for patients treated with the RNS System (2.8 per 1,000 patient-stimulation years) was significantly lower than similar patient populations.
“This study is the culmination of over a decade of research with leading epilepsy centers across the country,” said Martha Morrell, MD, CMO of NeuroPace and Principal Investigator. “The robust clinical evidence affirms the long-term benefits of the RNS System and clearly establishes it as part of the standard of care in the treatment of refractory epilepsy. It’s exciting to realize that we are just at the beginning of harnessing the power of the data captured by the RNS System. With growing clinical experience, as we saw in the real world study, and with advanced artificial intelligence research applied to our dataset of 4.5 million ECoG records, we can expect continued improvement in the efficacy of the RNS System.”