LivaNova’s CORE-VNS study of its VNS Therapy has yielded positive results, demonstrating that the neuromodulation treatment significantly reduces severe focal seizures in both children and adults with drug-resistant epilepsy (DRE).
According to LivaNova, the study, which involved over 800 patients globally, underscored the therapy’s potential as a viable treatment option in the marketplace.
The final 36-month data analysis further substantiates VNS Therapy’s effectiveness, establishing its role in the treatment landscape for epilepsy management.
LivaNova global medical affairs vice president Kathryn Nichol said: “LivaNova is deeply committed to advancing epilepsy research and in every study of VNS Therapy to date, we continue to see that effectiveness can be achieved early and continue to improve month by month and visit by visit. This remained true over the course of three years in CORE-VNS.
“Further, CORE-VNS confirms that VNS Therapy is effective for the most severe focal seizures in pediatric and adult patients. Not all seizures are created equal—this is why evaluating severe focal seizures that may have a larger impact on quality of life and outcomes in people with drug-resistant epilepsy is so important.”
The results confirm earlier interim findings presented at the American Epilepsy Society’s annual conference in December 2024.
The study illustrates that a considerable portion of participants across all age groups identified focal onset seizures with impaired awareness (FIA) as their most debilitating seizure type.
Among children aged 4 to 18, the therapy achieved a median reduction of 87% in FIA motor seizures after three years. Additionally, 34% of all patients reported complete freedom from seizures in the three months leading up to their follow-up visit.
Moreover, children within the same age bracket experienced a remarkable median reduction of 100% in focal to bilateral tonic-clonic (FBTC) seizures at the three-year mark.
Including adults, nearly half of the participants with FBTC seizures reported total cessation at this follow-up point, with an overall median reduction of 95%.
LivaNova indicated that the effectiveness of VNS Therapy became apparent as early as three months post-implantation, with continuous improvements noted at the 12-, 24-, and 36-month intervals.
The CORE-VNS study had shown participant retention rate of 82% over three years, making it the largest prospective study of VNS Therapy conducted internationally.
As a long-term open-label study focusing on DRE outcomes, CORE-VNS enrolled the patients from 61 sites worldwide. Adverse events reported during the study align with those indicated in product labelling and were primarily associated with device implantation, including respiratory and thoracic disorders such as dysphonia and cough.
LivaNova said that the VNS Therapy has been clinically established as a safe and effective adjunctive treatment for reducing seizure frequency in both adults and children from four years old who are diagnosed with drug-resistant epilepsy and partial onset seizures. This treatment modality presents a non-invasive alternative for patients whose conditions do not respond adequately to pharmacological interventions, thus expanding treatment options available to healthcare professionals.
