Long-term, real-world evidence demonstrates early and lasting outcomes of adjunctive VNS Therapy on severe focal seizures

LivaNova PLC , a market-leading medical technology company, announced completion of the CORE-VNS study, evaluating comprehensive outcomes of real-world evidence for more than 800 people with epilepsy treated with VNS Therapy worldwide. With the clinical study report (CSR) now complete, the final 36-month data further validate the effectiveness of VNS Therapy for severe focal seizures in both children and adults with drug-resistant epilepsy (DRE) and demonstrate early and lasting outcomes of adjunctive VNS Therapy on severe focal seizures.

Health Technology Insights: Kimedics Names Greg Gossett President to Scale Workforce Software

With the clinical study report now complete, the final 36-month data further validate the effectiveness of VNS Therapy for severe focal seizures in both children and adults with drug-resistant epilepsy and demonstrate early and lasting outcomes.

“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,” said Arjune Sen, Professor of Global Epilepsy at The University of Oxford and Consultant Neurologist at Oxford University Hospitals NHS Foundation Trust. Prof. Sen is also coordinating investigator for the CORE-VNS study.

Health Technology Insights: Avicenna.AI Secures CE Mark for Two Spine-Focused Medical Imaging AI Tools

The CORE-VNS 36-month data analysis reaffirms the effectiveness of VNS Therapy, in pediatric and adult patients, and expands upon LivaNova’s presentation of interim 24-month data evaluating the effectiveness of VNS Therapy in children ages 4 to 18 years old with focal onset seizures at the American Epilepsy Society’s annual conference in December 2024. Within the full 36-month analysis, the greatest proportion of patients at all ages reported focal onset seizures with impaired awareness (FIA) to be their most disabling seizure type. CORE-VNS study data demonstrate the impact of VNS Therapy, including:

  • In children 4 to 18 years old, FIA motor seizures, for example, reduced by a median of 87% at 36 months. Including adults, 34% of people with FIA motor seizures reported 100% seizure reduction (freedom from these seizures over the three months prior to their three-year study visit), with an overall median reduction of 80%.
  • In children 4 to 18 years old, focal to bilateral tonic-clonic (FBTC) seizures reduced by a median of 100% at 36 months. Including adults, 49% of people with FBTC seizures reported 100% seizure reduction at the three-year study visit, with an overall median reduction of 95%.
  • The effectiveness of VNS Therapy was noted as early as three months after implantation, followed by further substantial reduction noted in both FIA and FBTC seizures at the 12-, 24-, and 36-month study visits.
  • Unlike many long-term follow-up studies on DRE, CORE-VNS had a high patient-retention rate throughout the three years of follow-up (82%).

“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,” said Kathryn Nichol, Ph.D., Vice President Global Medical Affairs, LivaNova. “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.”

CORE-VNS is the largest prospective study of VNS Therapy ever conducted worldwide. The full, 36-month CORE-VNS study results will be published later this year.

“The strong outcomes from the CORE-VNS study bolster our efforts to narrow the DRE treatment gap, increase access to care, and drive awareness of surgical therapies for this significantly under-addressed patient population,” said Stephanie Bolton, LivaNova President, Global Epilepsy.

Health Technology Insights: Elsevier Launches Evaluation Framework for GenAI Clinical Tools

To participate in our interviews, please write to our HealthTech Media Room at sudipto@intentamplify.com

Source – businesswire