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LivaNova Announces Enrollment for PERFECT Perceval Valve Clinical Trial in China

Mar 22, 2018

Pre-market trial to demonstrate safety and effectiveness of Perceval sutureless aortic heart valve

LONDON--(BUSINESS WIRE)--Mar. 22, 2018-- LivaNova PLC (NASDAQ:LIVN) (“LivaNova” or the “Company”), a market-leading medical technology company, has announced the first patient enrollment in the Perceval® Valve Clinical study for Chinese Registration (“PERFECT”) Trial. The study is a pre-market, prospective, single-arm trial. The PERFECT trial is being conducted to demonstrate the safety and effectiveness of the Perceval sutureless aortic heart valve when used to replace a diseased native or malfunctioning prosthetic aortic valve in the indicated Chinese population for tissue heart valve replacement.

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“This is a critical milestone in our ongoing commitment to provide access to Perceval within the Chinese cardiac surgery community and to patients, who ultimately benefit the most,” said Roy Khoury, LivaNova’s President of the International Region.

The PERFECT trial is expected to enroll approximately 160 patients who will receive five years of follow-up at eight investigational sites in China. The primary endpoint of the trial is a one-year composite endpoint of major cardiac events as per the Clinical Events Committee adjudication.

“Through the PERFECT trial, we reinforce our commitment to market expansion and take another important step toward meeting the increasing global need for advanced aortic valve solutions,” said Alistair Simpson, General Manager of LivaNova’s Cardiac Surgery business franchise. “We are eager to enhance patient care through expanded access to our truly sutureless valve technology.”

Perceval is specifically designed to reduce the physiological impact of aortic valve replacement, simplify complex and minimally invasive procedures, and improve patient outcomes. The Perceval sutureless valve has become a trusted platform supported by a strong body of evidence and more than 10 years of clinical experience.

“We greatly look forward to the possibility of making this innovative technology, which has demonstrated excellent outcomes in Europe and the United States, available to patients in China,” said Professor Shengshou Hu, Principal Investigator and President of Fu Wai Hospital, Chinese Academy of Medical Sciences, Beijing, China. “The excellent hemodynamic characteristics of the Perceval valve, along with its suitability for less invasive approaches, makes introduction of this valve to the greater Chinese population particularly appealing.”

The highly versatile, truly sutureless Perceval biological valve has optimized aortic valve surgery. Perceval reflects LivaNova’s continued innovation and commitment to improving surgical outcomes and long-term survival, while providing surgeons with a trusted and highly durable cardiac surgery platform.

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.

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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
Deanna Wilke, +1 (281) 727-2764
Corporate External Communications Manager