The first patient with drug-resistant epilepsy has received LivaNova’s (NASDAQ:LIVN) vagus nerve stimulation (VNS) therapy system, kicking off enrollment of a global registry to evaluate it, the company said.
Drug-resistant epilepsy (DRE) affects nearly one in three people with epilepsy, according to an article in the New England Journal of Medicine. The LivaNova 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 the CORE-VNS study 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 LivaNova’s VNS therapy technology, and was enrolled at Pediatric Neurology and Epilepsy Specialists in Florida. In Europe, the first CORE-VNS patient was enrolled at Oxford University Hospitals NHS Foundation Trust in the United Kingdom with implant soon to follow.
The registry will include up to 80 sites, collecting outcomes in real-world settings. 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.
“Many patients with drug-resistant epilepsy have tried numerous treatment options with limited results,” said Bryan Olin, LivaNova’s senior vice president of clinical, quality assurance and regulatory affairs, in a prepared statement. “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.”
VNS therapy received CE Mark in 1994 and FDA 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.