LONDON--(BUSINESS WIRE)--LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced the first implanted patient and official launch of a global registry to evaluate the use of LivaNova’s Vagus Nerve Stimulation Therapy® (VNS Therapy) System for patients with drug-resistant epilepsy (DRE), which affects nearly one in three people with epilepsy.1 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.
“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,” said Bryan Olin, LivaNova’s Senior Vice President of Clinical, Quality Assurance and Regulatory Affairs. “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.
For more information on VNS Therapy, please visit www.VNSTherapy.com.
About VNS Therapy for Epilepsy
VNS Therapy is clinically proven safe and effective for the treatment of drug-resistant epilepsy for adults and children. VNS Therapy is designed to prevent seizures before they occur and stop them if they do. It is a unique treatment approach developed for people with drug-resistant epilepsy—a condition that affects one in three people with epilepsy. For more information, visit www.VNSTherapy.com or www.VNSTherapy.co.uk.
INTENDED USE/INDICATIONS – EU
The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalization) or generalized seizures that are refractory to seizure medications.
INTENDED USE/INDICATIONS – US
The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients 4 years of age and older with partial onset seizures that are refractory to antiepileptic medications.
Individual results may vary. Common side effects include hoarseness, shortness of breath, sore throat and coughing.
To view safety and full prescribing information, visit www.VNSTherapy.com/safety or www.VNSTherapy.co.uk/safety-information.
About LivaNova
LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. LivaNova’s advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems. Headquartered in London, LivaNova has a presence in more than 100 countries worldwide. The Company currently employs approximately 4,000 employees. LivaNova operates as two businesses: Cardiac Surgery and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.A.), respectively.
For more information, please visit www.livanova.com.
Safe Harbor Statement
This news release contains forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended, and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements are not historical facts but are based on certain assumptions of management and describe LivaNova’s future plans, strategies and expectations. Forward-looking statements can generally be identified by the use of forward-looking terminology, including, but not limited to, "may," “could,” “seek,” “guidance,” “predict,” “potential,” “likely,” "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," "forecast," or variations of these terms and similar expressions, or the negative of these terms or similar expressions. Forward-looking statements contained in this news release are based on information presently available to LivaNova and assumptions that LivaNova believes to be reasonable, but are inherently uncertain. As a result, LivaNova’s actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements, which are not guarantees of future performance or actions that may be taken by LivaNova and involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond LivaNova’s control. You should carefully consider the risks and uncertainties that affect LivaNova, including those described in the “Risk Factors” section of LivaNova’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from time to time with the United States Securities and Exchange Commission.
All information in this news release is as of the date of its release. LivaNova does not undertake or assume any obligation to update publicly any of the forward-looking statements in this news release to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. We caution you not to place undue reliance on any forward-looking statements, which are made only as of the date of this news release.
1 The New England Journal of Medicine. Drug-Resistant Epilepsy. Patrick Kwan, M.D., Ph.D., Steven C. Schachter, M.D., and Martin J. Brodie, M.D.
