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LivaNova PLC Receives Regulatory Approval in Japan for the Solo Smart Stentless Tissue Aortic Valve

LivaNova PLC
Press release

LivaNova PLC Receives Regulatory Approval in Japan for the Solo Smart Stentless
Tissue Aortic Valve

Solo Smart is a Native-Like Aortic Valve Replacement Option With Excellent
Hemodynamic Performance and Clinical Outcomes

LONDON, 2016-02-29 15:00 CET (GLOBE NEWSWIRE) --
LivaNova, PLC (NASDAQ:LIVN) (LSE:LIVN), a global medical technology company and
a leader in the treatment of cardiovascular diseases, today announced that it
has received approval from Japan’s Pharmaceutical and Medical Devices Agency
(PMDA) for its Solo Smart stentless tissue valve, the only valve designed to
provide superior hemodynamics with the ease of a stented bioprosthesis

Designed from bovine pericardium, the Solo Smart valve is fully biological with
no synthetic material added, allowing the valve to mimic the healthy native
aortic valve. Solo Smart maximizes the blood flow and delivers excellent
hemodynamic performance and patient outcomes while providing a simplified
implant procedure method with a removable stent for straightforward
implantation and optimal positioning.

“Since their introduction in the 1990s, stentless bioprosthetic valves have
represented a major stride in valve design and hemodynamic performance for
aortic valve replacement options,” said Alberto Repossini, M.D., Cardiac
Surgery University of Brescia, Spedali Civili, Brescia, Italy. ”Solo Smart is a
unique prosthesis with a temporary stent removed during its implantation for
optimal positioning. Once the stent is removed, Solo Smart becomes an entirely
stentless valve, providing low pressure gradients and large orifice

Available also in Europe and the U.S., the Solo Smart stentless valve is
designed for patients with an active lifestyle, those who are at risk of PPM
(Patient Prosthesis Mismatch) or require a concomitant aortic valve replacement

“In collaboration with our established partner, Japan Lifeline, LivaNova is
pleased to introduce the Solo Smart stentless valve for aortic valve
replacement in Japan,” said Michel Darnaud, President, Cardiac Surgery Business
Unit, LivaNova. “With Solo Smart valve and its long-term data paired with
simplified implantability, surgeons are empowered with state-of-the-art
technology and the confidence to perform AVR procedures more effectively.”

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.


1 Repossini A, Rambaldini M, Lucchetti V, et al. Early clinical and hemodynamic
results after aortic valve replacement with the Freedom SOLO bioprosthesis
(experience of Italian multicenter study). Eur J Cardiothorac Surg.
2 Beholz S, Repossini A, Livi U, et al. The Freedom SOLO Valve for Aortic Valve
Replacement: Clinical and Hemodynamic Results from a Prospective Multicenter
Trial. The Journal of Heart Valve Disease. 2010;19:115-123.
3 Horst M, Easo J, Hölzl PPF, et al. The Freedom Solo Valve: Mid-Term Clinical
Results with a Stentless Pericardial Valve for Aortic Valve Replacement. The
Journal of Heart Valve Disease. 2011;20:704-710.
4 Clinical Experience With the Freedom Solo Stentless Aortic Valve in 277
Consecutive Patients.
Thalmann M, Kaiblinger J, Krausler R, Pisarik H, Veit F, Taheri N, Kornigg K,
Dinges C, Grabenwöger M, Stanger O. Ann Thorac Surg. 2014 Oct;98(4):1301-7.
5 Clinical and haemodynamic outcomes in 804 patients receiving the Freedom SOLO
stentless aortic valve: results from an international prospective multicentre
Grubitzsch H, Wang S, Matschke K, Glauber M, Heimansohn D, Tan E, Francois K,
Thalmann M.
Eur J Cardiothorac Surg. 2015 Mar;47(3):e97-e104
6 Long term durability and haemodynamic performance of freedom solo stentless
valve for aortic valve replacement: a european, multicenter experience”.
Repossini et al. Presented at AHA Congress – Nov 2015

For more information, please visit, or contact:

Investor Relations:
Vivid Sehgal
Chief Financial Officer

Investor Relations and Media:
Greg Browne
Senior Vice President, Finance
Phone: +1 (281) 228-7262
Fax: +1 (281) 218-9332

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