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New Data Emphasizing LivaNova Perceval Valve Durability to be Presented at the American Association for Thoracic Surgery Meeting

May 3, 2019

Key findings from study at Leuven University Hospital show no explants due to structural valve deterioration in 11 years of Perceval use

LONDON--(BUSINESS WIRE)--May 3, 2019-- LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced that new clinical data for its sutureless surgical aortic valve, Perceval®, will be unveiled at this year’s American Association for Thoracic Surgery (AATS) meeting.

On May 4, Prof. Bart Meuris from Leuven University Hospital (BE) will present the data from his center’s 11-year clinical experience with Perceval, which represents the longest clinical follow-up for the valve that has been published. The results demonstrate the strong performance of the Perceval valve both in terms of durability and outcomes, which reaffirm its position as a trusted platform. Of particular significance in the findings is the absence of explants due to structural valve deterioration (SVD), as well as the low rate of paravalvular leak (PVL) reported.

The retrospective, observational, single-center study included 468 consecutive patients implanted with Perceval between 2007 and 2017:

  • Patient mean age was 79, mean EuroSCORE II was 5.0 and STS score was 5.8.
  • The majority of the cases treated were all-comers, including emergencies.
  • 55% of cases were conducted as part of concomitant procedures, while a high rate of the isolated aortic valve replacement (AVR) cases was carried out through minimally invasive surgery.

This new clinical data folds into the extensive literary evidence already available surrounding the Perceval technology and its use in hospitals around the world.

“The Perceval sutureless valve offers a stable, time-saving and safe surgical result, both in isolated and in combined procedures,” said Prof. Meuris based on the results from his 11-year experience with Perceval. “We observed promising long-term durability given the current low incidence of SVD after 11 years of continued clinical use.”

“It is critical for a distinctive technology such as Perceval to have strong, real life data to back up its success,” said Alistair Simpson, LivaNova General Manager of Cardiac Surgery. “We are extremely proud of these impressive results at Leuven that further demonstrate the versatility of our valve in isolated and concomitant procedures. The fact that no explants were carried out as a result of SVD, and that PVL was very low is a testament to the quality of our innovative valve design and to our commitment of improving patient care.”

The presentation by Prof. Meuris, “Sutureless AVR Experience in a Single Centre: 11 Years of Use in 468 Patients,” will take place on May 4 at AATS 2019 in Toronto:

  • Session Name: Minimal Surgery and Novel Approaches
  • Session Time: 10 - 11:30 a.m.
  • Session Location: MTCC, 206AC
  • Presentation Time: 11 - 11:15 a.m.

To read the abstract from the presentation, visit the AATS website.

For more information on the Perceval valve, visit www.livanova.com.

Important Safety Information

INDICATIONS

EUROPE: The Perceval prosthesis is indicated for the replacement of diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The prosthesis is indicated for use in adult patients who are diagnosed to have aortic valve stenosis or steno-insufficiency.

USA: The Perceval bioprosthesis is indicated for the replacement of diseased, damaged or malfunctioning native or prosthetic aortic valves.

CANADA: The Perceval S bioprosthesis is intended for use in patients aged ≥ 65 years when the aortic valve pathology is in an advanced stage to require the replacement of the native or malfunctioning previously implanted prosthesis.

AUSTRALIA: Perceval S prosthesis is indicated for the replacement of a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. The prosthesis is indicated in patients who meet the following criteria: 1) subjects of age ≥ 65 years 2) subjects with aortic valve stenosis or steno-insufficiency.

TOP POTENTIAL SIDE EFFECTS

The risks or potential adverse events associated with cardiac valve replacement with a bioprosthesis include, but may not be limited to: cardiac arrhythmias, death, endocarditis, heart failure, hemorrhage, intravalvular and/or paravalvular leak, stroke or any related neurologic disorders, structural valve deterioration, reoperation and explant. Beyond the previously mentioned adverse events, specific events related to the implant of the Perceval prosthesis may include, but not be limited to dislodgment and/or migration of the prosthesis.

MRI conditional. For professional use. Please contact us through our website to receive instructions for use containing full prescribing information, including indications, contraindications, warnings, precautions and adverse events. Not approved in all geographies. Consult your labeling.

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: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), 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.

Source: LivaNova PLC

LivaNova PLC Media Contact
Deanna Wilke, +1 (281) 727-2764
Director, Corporate Communications
Corporate.Communications@livanova.com