LONDON--(BUSINESS WIRE)--Mar. 28, 2018--
LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a
market-leading medical technology company, today announced the launch
and enrollment of the first patient in a clinical study to examine the
use of LivaNova’s new Microburst Vagus Nerve Stimulation Therapy®
(“VNS Therapy”) System. This feasibility study will determine the
initial safety and effectiveness of delivering VNS Therapy using high
frequency bursts of stimulation (“Microburst”) in patients who have
drug-resistant epilepsy (“DRE”).
“LivaNova is launching this study to enrich our understanding of
epilepsy patient populations and the significant role VNS Therapy can
play in the overall management of this disease,” said Edward Andrle,
LivaNova’s General Manager of its Neuromodulation business franchise.
“Through the Microburst feasibility study, we have the opportunity to
evaluate a prospective new feature for VNS Therapy where stimulation is
delivered in higher frequency bursts rather than gradual intervals.”
The Microburst feasibility study’s first patient was enrolled by Dr.
Rebecca O’Dwyer, Assistant Professor of Neurology, at the Rush
University Medical Center in Chicago, Illinois. The pre-market study
consists of two cohorts, enrolling up to 40 patients in total at
approximately 15 sites in the United States. Cohort 1 will include 20
patients with primary generalized tonic-clonic seizures. Cohort 2 will
consist of 20 patients with partial onset seizures, including complex
partial seizures with or without secondary generalization. Each patient
will participate in the study for a minimum of 15 months. Primary
endpoints will measure the percent change in seizure frequency and
occurrence of stimulation-related adverse events in comparison to a
patient’s baseline. Activation of various areas of the brain in response
to stimulation will be assessed using functional magnetic resonance
imaging or fMRI. Secondary endpoints will be evaluated to assess changes
from baseline in seizure severity, quality of life, antiepileptic drug
use, suicidality and adverse events.
“At the Rush Epilepsy Center, we are very dedicated to research and
advancing the field of epilepsy therapeutics for patients,” said Dr.
O’Dwyer. “It is an honor to have enrolled the first patient in the
Microburst VNS Therapy Feasibility Study, and we look forward to the
resulting impact it will have on this patient population.”
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.
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 more than 4,500 employees, inclusive of
approximately 900 employed by our CRM business franchise.
LivaNova operates as three business franchises: Cardiac Surgery,
Neuromodulation and Cardiac Rhythm Management, with operating
headquarters in Mirandola (Italy), Houston (U.S.A.) and Clamart
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.
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20180328005647/en/
Source: LivaNova PLC
LivaNova PLC Investor Relations and Media
Karen King, +1
Vice President, Investor Relations & Corporate
Deanna Wilke, +1 (281) 727-2764
External Communications Manager