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LivaNova Commences Clinical Study to Evaluate Treatment Outcomes for Novel Microburst VNS Therapy System

Mar 28, 2018

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.

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 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 (France), 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.

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.

Source: LivaNova PLC

LivaNova PLC Investor Relations and Media
Karen King, +1 (281) 228-7262
Vice President, Investor Relations & Corporate Communications
or
Deanna Wilke, +1 (281) 727-2764
Corporate External Communications Manager
corporate.communications@livanova.com