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2016-02-01

LivaNova plc: LivaNova PLC Announces FDA Approval of Stented Heart Valve CROWN PRT(TM) for Aortic Valve Disease

LivaNova Demonstrates Commitment to Advancing Cardiac Surgery Through Broad
Portfolio of Aortic Valve Replacement Solutions

LONDON, Feb. 01, 2016 (GLOBE NEWSWIRE) -- LivaNova PLC (NASDAQ:LIVN)
(LSE:LIVN) (the "Company"), a global medical technology company and a leader
in the treatment of cardiovascular diseases, today announced it has been
granted approval from the United States Food and Drug Administration (FDA)
for its innovative stented aortic bioprosthesis CROWN PRT for the treatment
of aortic valve disease. This is the second valve to be approved in the U.S.
this year and is expected to be launched in the coming months. LivaNova's
Perceval valve, the sutureless biological valve on the market for aortic
valve replacement procedures, was approved on January 8, 2016.

The CROWN PRT is the latest advancement in stented aortic bioprosthesis
technology and features a surgeon-friendly design, optimizing hemodynamics
and the patented Phospholipid Reduction Treatment (PRT), which was designed
to enhance valve durability. As a high-performing, durable valve, CROWN PRT
is an ideal aortic valve replacement option for older patients.

"CROWN PRT is a modern bioprosthesis enabling a simple, safe, reliable and
reproducible cardiac surgery procedure for patients in need of an aortic
valve replacement," said Prof. Rainald Seitelberger, M.D., Salzburg
University Clinic in Austria. "Data have shown that phospholipids play an
important role in the calcification process of bioprosthesis, and LivaNova's
CROWN PRT has proven to decrease phospholipid content in the tissue1 leading
to superior valve longevity. CROWN PRT's durability, along with its ease of
use during procedures and ability to provide excellent hemodynamic
performance, makes it an ideal valve for current and future aortic valve
replacements."

CROWN PRT enables intuitive intraoperative handling through enhanced ease of
implant with visible markers and improved radiographic visualization through
dedicated X-ray markers. The stented aortic heart valve replacement is
strategically designed to provide physicians with greater surgical
versatility and provides patients a long-lasting valve replacement.

"LivaNova is excited to launch CROWN PRT with its outstanding hemodynamic
performance and durability, and we look forward to its adoption in the
dynamic and evolving market of cardiac surgery," said Michel Darnaud,
President, LivaNova Cardiac Surgery Business Unit. "With nearly 50 years of
experience in heart valve design and innovation, LivaNova is proud to be the
only cardiac surgery company offering the most comprehensive spectrum of
heart valves available in the U.S., including sutureless, stented and
stentless valves. The introduction of our state-of-the-art aortic valve
technologies, CROWN PRT and Perceval valve, reflects LivaNova's commitment to
providing cardiac surgery treatments that optimize a surgeon's ability to
deliver the best care possible to their patients."

To learn more about LivaNova and its broad range of cardiac surgery solutions,
including the Perceval and CROWN PRT, please visit: www.livanova.com.

References: 1 Based on 60-day animal model. Data on file.

About LivaNova

LivaNova PLC, headquartered in London, UK, is a global medical technology
company formed by the merger of Sorin S.p.A, a leader in the treatment of
cardiovascular diseases, and Cyberonics Inc., a medical device company with
core expertise in neuromodulation. LivaNova transforms medical innovation
into meaningful solutions for the benefit of patients, healthcare
professionals, and healthcare systems. The company employs approximately
4,500 employees worldwide. With a presence in more than 100 countries,
LivaNova operates as three business units: Cardiac Rhythm Management, Cardiac
Surgery, and Neuromodulation, with operating headquarters in Clamart
(France), Mirandola (Italy) and Houston (U.S.A.), respectively.

LivaNova is listed on NASDAQ and listed on the Official List of the UK's
Financial Conduct Authority and traded on London Stock Exchange (LSE) under
the ticker symbol "LIVN".

Safe harbor statement

This press release contains forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended and Section 21E of the
Securities Exchange Act of 1934, as amended. These statements can be
identified by the use of forward-looking terminology, including "may,"
"believe," "will," "expect," "anticipate," "estimate," "plan," "intend,"
"forecast," or other similar words. Statements contained in this press
release are based on information presently available to LivaNova and
assumptions that the parties believe to be reasonable. LivaNova is not
assuming any duty to update this information if those facts change or if the
assumptions are no longer believed to be reasonable. Investors are cautioned
that all such statements involve risks and uncertainties, including without
limitation, statements concerning developing novel opportunities in heart
failure, sleep apnea and percutaneous mitral valve, creating new innovative
solutions that benefit patients, healthcare professionals, and healthcare
systems, and building significant shareholder value. Important factors that
may cause actual results to differ include, but are not limited to: risks
that the new businesses will not be integrated successfully or that the
combined companies will not realize estimated cost savings, value of certain
tax assets, synergies and growth, or that such benefits may take longer to
realize than expected; the inability of LivaNova to meet expectations
regarding the timing, completion and accounting and tax treatments; risks
relating to unanticipated costs of integration, including operating costs,
customer loss or business disruption being greater than expected; reductions
in customer spending, a slowdown in customer payments and changes in customer
demand for products and services; unanticipated changes relating to
competitive factors in the industries in which the company operates; the
ability to hire and retain key personnel; the ability to attract new
customers and retain existing customers in the manner anticipated; reliance
on and integration of information technology systems; changes in legislation
or governmental regulations affecting the company; international, national or
local economic, social or political conditions that could adversely affect
the company or its customers; conditions in the credit markets; risks to the
industries in which LivaNova operates that are described in the "Risk
Factors" section of the Annual Reports on Form 10-K, Quarterly Reports on
Form 10-Q and other documents filed from time to time with the SEC by
Cyberonics, Inc. and LivaNova and the analogous section in annual reports and
other documents filed from time to time by Sorin S.p.A. with the Italian
financial market regulator (CONSOB); risks associated with assumptions made
in connection with critical accounting estimates and legal proceedings;
LivaNova's' international operations, which are subject to the risks of
currency fluctuations and foreign exchange controls; and the potential of
international unrest, economic downturn or effects of currencies, tax
assessments, tax adjustments, anticipated tax rates, raw material costs or
availability, benefit or retirement plan costs, or other regulatory
compliance costs. The foregoing list of factors is not exhaustive. You
should carefully consider the foregoing factors and the other risks and
uncertainties that affect the parties' businesses, including those described
in Cyberonics' Annual Report on Form 10-K, as amended from time to time,
Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other
documents filed from time to time with the SEC by Cyberonics and LivaNova and
those described in Sorin's annual reports, registration documents and other
documents filed from time to time with CONSOB by Sorin. LivaNova does not
give any assurance (1) that LivaNova will achieve its expectations, or (2)
concerning any result or the timing thereof, in each case, with respect to
any regulatory action, administrative proceedings, government investigations,
litigation, warning letters, consent decree, cost reductions, business
strategies, earnings or revenue trends or future financial results.
For more information, please visit www.livanova.com, or contact:
Investor Relations:
Vivid Sehgal
Chief Financial Officer
e-mail: investor.relations@livanova.com

Investor Relations and Media:
Greg Browne
Senior Vice President, Finance
Phone: +1 (281) 228-7262
Fax: +1 (281) 218-9332
e-mail: corporate.communications@livanova.com

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This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: LivaNova plc via Globenewswire

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