LivaNova has completed the CORE-VNS study, assessing outcomes via real-world evidence on the use of the VNS Therapy device in over 800 individuals with epilepsy.
The study’s final 36-month data confirms the therapy’s effectiveness on severe focal seizures in paediatric and adult patients with drug-resistant epilepsy (DRE), showing early and sustained benefits.
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This open-label, long-term study enrolled participants from 61 sites around the world.
The majority of the subjects, across all age groups, reported focal onset seizures with impaired awareness (FIA) as their most disabling seizure type.
According to the study’s data, for children aged four to 18, there was an 87% median reduction in FIA motor seizures at 36 months.
Inclusive of adults, 34% of subjects with FIA motor seizures achieved 100% seizure minimisation, with an overall median decrease of 80%.
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By GlobalDataSimilarly, focal to bilateral tonic-clonic (FBTC) seizures saw a median reduction of 100% in children, and 49% of all participants with FBTC seizures reported complete seizure minimisation at their three-year study visit.
VNS Therapy’s effectiveness was observed as early as three months post-implantation, with further substantial decreases in both FIA and FBTC seizures observed at subsequent 12-, 24-, and 36-month visits.
Notably, the CORE-VNS study claimed to have a high patient retention rate of 82% over the three-year follow-up period.
LivaNova noted that VNS Therapy is an add-on treatment designed to decrease the seizure frequency in individuals aged four and above with DRE and partial-onset seizures.
Involving an outpatient procedure, the implantation of this therapy does not involve skull penetration.
The outcomes of the 36-month CORE-VNS study are set to be published later in the year.
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.”
Last year, the company reported positive predictive outcomes from the OSPREY study of the aura6000 hypoglossal nerve stimulator system for treating obstructive sleep apnoea.
