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LivaNova Launches Global Clinical Registry to Assess VNS Therapy Treatment for Drug-Resistant Epilepsy Patients


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

"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

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


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


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

Individual results may vary. Common side effects include hoarseness,
shortness of breath, sore throat and coughing.

To view safety and full prescribing information, visit

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

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.

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