LivaNova PLC has completed its landmark CORE-VNS study, providing comprehensive real-world evidence of VNS Therapy's effectiveness in treating drug-resistant epilepsy across more than 800 patients worldwide. The 36-month clinical study report validates the sustained benefits of vagus nerve stimulation therapy for severe focal seizures in both pediatric and adult populations.
Significant Seizure Reduction Across Patient Populations
The CORE-VNS study demonstrated substantial and sustained seizure reduction, with particularly impressive results for generalized tonic-clonic (GTC) seizures. At 12 months, patients experienced a median 74% reduction in GTC seizure frequency, which increased to 77% at 24 months. Notably, 43% of participants achieved complete freedom from GTC seizures at the 24-month mark, compared to 37% at 12 months.
"GTC seizures can be some of the most severe and debilitating seizures a patient can experience," said Dr. Ana Suller Marti, Assistant Professor of Neurology at Western University and lead author of the GTC seizure analysis. "The observed reductions in seizure frequency and severity, as well as the achievement of complete seizure freedom in some cases, are key findings that clinicians should be aware of."
Early and Lasting Treatment Benefits
The study revealed that VNS Therapy's benefits emerge early in treatment, with a median 52% reduction in GTC seizure frequency observed at just three months post-implantation. This early response pattern was sustained throughout the 36-month study period, demonstrating the therapy's durability.
Professor Arjune Sen of The University of Oxford, who served as coordinating investigator, emphasized the clinical significance: "It is critically important to conduct long-term, real-world studies like CORE-VNS, and it is pleasing to see these clinically meaningful and durable results demonstrating the effectiveness of VNS Therapy for people living with drug-resistant epilepsy."
Addressing Severe Treatment-Resistant Cases
The study population represented patients with particularly challenging epilepsy cases. Participants had failed a median of six anti-seizure medications, with some having tried as many as 20 different drugs. The median duration between epilepsy diagnosis and VNS Therapy implantation was 10 years, and patients experienced a median of four tonic-clonic seizures per month at baseline.
"I am struck by the significant seizure burden carried by the people, many of whom are so young, in this real-world dataset," noted Stephanie Bolton, LivaNova President of Global Epilepsy. Approximately half of those experiencing GTC seizures were under 18 years of age, and 90% of participants were under 18 at the time of their initial epilepsy diagnosis.
Comprehensive Real-World Evidence
CORE-VNS represents the most comprehensive assessment of VNS Therapy effectiveness to date, enrolling patients from 61 worldwide sites. The study focused on focal onset seizures with impaired awareness (FIA), which represented the most disabling seizure type reported by the greatest proportion of patients across all age groups.
The therapy's safety profile remained consistent with previous studies, with the most commonly reported adverse events including dysphonia, cough, neck/oropharyngeal pain, and general discomfort. Notably, 94% of participants with GTC seizures had no history of previous epilepsy surgery, highlighting VNS Therapy's role as a less invasive treatment option.
VNS Therapy is approved as an adjunctive treatment for drug-resistant epilepsy in adults and children as young as 4 years old with partial onset seizures. The therapy involves an outpatient implantation procedure that does not require skull penetration, distinguishing it from other surgical epilepsy treatments.
