LivaNova has announced the first implanted patient and official launch of a global registry to evaluate the use of its Vagus Nerve Stimulation Therapy (VNS Therapy) system for patients with drug-resistant epilepsy (DRE).
The comprehensive outcomes registry in subjects with epilepsy treated with VNS Therapy (CORE-VNS) study will enroll up to 2,000 patients with five-year follow-up data, yielding one of the largest data sets in the world for DRE patients treated with various generations of VNS Therapy.
Data from CORE-VNS will contribute to the body of research related to this disease state and advance the science behind VNS Therapy by evaluating the safety, effectiveness and clinical outcomes for patients.
The first implanted CORE-VNS patient received a SenTiva® generator, the latest in VNS Therapy technology, and was enrolled at Pediatric Neurology and Epilepsy Specialists (PENS) in Florida by Dr. Jose Ferreira, PENS Medical Director.
In Europe, the first CORE-VNS patient was enrolled by Prof. Arjune Sen at Oxford University Hospitals NHS Foundation Trust in the United Kingdom with implant soon to follow.
The registry will include up to 80 sites globally, collecting outcomes in real-world settings by following participating patients for up to five years after treatment begins.
Documented clinical outcomes will include seizure frequency, seizure severity, quality of life, quality of sleep, antiepileptic drug use, and seizure-related emergency visits and hospitalizations.
LivaNova clinical, quality assurance and regulatory affairs senior vice president Bryan Olin said: “Many patients with drug-resistant epilepsy have tried numerous treatment options with limited results. The CORE-VNS study will give us a greater understanding of the drug-resistant epilepsy patient population around the world and the role VNS Therapy can play in the overall management of this disease.
“Additionally, this study will allow us to evaluate the latest advancements in VNS Therapy, including the capability to track and use real-time patient data to inform treatment.”
Dr. Kore Liow, FACP, FAAN, from the Comprehensive Epilepsy Center at Hawaii Pacific Neuroscience and Clinical Professor at the University of Hawaii John Burns School of Medicine, has enrolled the most patients to date in the CORE-VNS registry in preparation for VNS Therapy implants.
“By following these patients for five years, we will gain a significant amount of high-quality, real-world clinical data on VNS Therapy as an adjunctive treatment for drug-resistant epilepsy,” said Liow.
VNS Therapy received CE Mark in 1994 and U.S. Food and Drug Administration approval in 1997 as an adjunctive treatment for drug-resistant epilepsy.
The system consists of two implantable components: a programmable electronic pulse generator that is connected to a bipolar electrical lead, which sends mild pulses to stimulate the vagus nerve at regular intervals throughout the day.
Source: Company Press Release