LivaNova Announces CORE-VNS 24-Month Data

LivaNova PLC is sharing positive 24-month data showing its epileptic seizure prevention technology reduced seizure frequency over the course of two years.

CORE-VNS three-year study results were recently published in Epilepsia.¹ The trial assessed the impact of LivaNova’s VNS Therapy on generalized tonic-clonic (GTC) seizures in people with drug-resistant epilepsy (DRE). The data show:

• The median reduction in GTC seizure frequency at 12 months was 74%; this reduction was sustained through 24 months with a median reduction increasing to 77%.  
• Freedom from GTC seizures (defined as the absence of GTC seizures in the three months prior to the study visit) was reported by 37% and 43% of people at the 12- and 24-month study visits, respectively, despite people having a median 10-year duration of epilepsy. 
• Approximately half of those experiencing GTC seizures were younger than 18, and nearly all (94%) had no history of any other previous surgery for epilepsy.  
• GTC seizure reduction was seen early, with a median 52% reduction in GTC seizure frequency at the three-month study visit.

“GTC seizures can be some of the most severe and debilitating seizures a patient can experience,” said Ana Suller Marti, M.D., assistant professor of Neurology at Western University in London, Ontario, Canada, and lead study author. “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.” 

The CORE-VNS study evaluated comprehensive outcomes of real-world evidence for more than 800 epilepsy patients treated with VNS Therapy worldwide. The 115 people with drug-resistant epilepsy and generalized seizures at baseline in this analysis had a median of 10 years between epilepsy diagnosis and VNS Therapy implantation. Additionally, 90% of this participant population were younger than 18 when they were diagnosed.

“I am struck by the significant seizure burden carried by the people, many of whom are so young, in this real-world dataset. Participants in this study failed a median number of six anti-seizure medications—some even as high as 20—and had a median of four tonic-clonic seizures per month at baseline,” stated Stephanie Bolton, LivaNova president of Global Epilepsy. “Our focus remains on contributing to the science of the treatment of epilepsy, working in partnership with physicians, and transparently communicating the latest scientific information available.”

CORE-VNS participants have been followed through the 36-month study interval, and LivaNova is currently preparing to publish 36-month study outcomes.

CORE-VNS is a real-world, long-term, open-label study focused on VNS Therapy outcomes in DRE patients. Enrolling more than 800 people from 61 worldwide sites, the study is believed to be the most comprehensive assessment of VNS Therapy efficacy to date.

Adverse events in this published clinical trial were typical following placement of a VNS Therapy device. The most commonly reported adverse events among participants with GTCs were dysphonia, cough, neck/oropharyngeal pain, and general discomfort. 

VNS Therapy is clinically proven safe and effective as an add-on treatment to reduce the frequency of seizures in adults and children as young as 4 years old with DRE and partial onset seizures. This treatment approach was developed for people with DRE, a condition that affects approximately one in three people with epilepsy. Unlike some other surgical treatment options for people with drug-resistant epilepsy, VNS Therapy implantation involves an outpatient procedure and does not require skull penetration. Outside the United States, the VNS Therapy indications for use may vary. 

VNS Therapy has not been approved by the U.S. Food and Drug Administration (FDA) for use in primary generalized seizures, and VNS Therapy safety and effectiveness for reducing primary generalized seizures has not been established. The VNS Therapy system is contraindicated for use in patients with a bilateral or left cervical vagotomy. 

LivaNova PLC is a global medical technology company built on nearly five decades of experience and a commitment to deliver life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 workers and has a presence in more than 100 countries.

References
¹ Suller Marti A, Verner R, Keezer M, et al. Reduction of generalized tonic-clonic seizures following vagus nerve stimulation therapy: CORE-VNS Study 24-month follow-up. Epilepsia. Published online April 1, 2025. doi:10.1111/epi.18371