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2016-05-05

LivaNova: Miscellaneous

SonR: 35% Risk Reduction in Heart Failure Hospitalization

RESPOND-CRT LANDMARK TRIAL REVEALS A REDUCED RISK IN HEART FAILURE
HOSPITALIZATION WITH LIVANOVA'S EXCLUSIVE SONR SENSOR-BASED CRT OPTIMIZATION
SYSTEM

LONDON, May 05, 2016 (GLOBE NEWSWIRE) -- LivaNova, PLC (NASDAQ:LIVN)
(LSE:LIVN), a market-leading medical technology and innovation company, today
announced results from the RESPOND-CRT clinical trial, showing that a 35%
risk reduction in heart failure hospitalization was associated with SonR.

The RESPOND-CRT trial was designed to investigate the clinical efficacy and
safety of device-based optimization using the SonR cardiac contractility
sensor in patients with advanced heart failure. The results, announced today
by Prof. Josep Brugada at an oral late breaking presentation during the
annual Heart Rhythm Society Meeting, showed that the study successfully met
its primary and secondary end points.

The proprietary SonR optimization system allows for cardiac resynchronization
therapy to be continuously adapted to the needs of each patient, thus
delivering individualized therapy.

In the RESPOND-CRT trial, optimization with SonR was compared to optimization
using echocardiography. Even though echo-guided optimization was considered
best practice in terms of reducing the number of non-responders to CRT, it
has never been widely adopted in routine practice because of the significant
resource consumption it requires.

The overall positive response to CRT reached in the group of patients treated
with SonR was 75%, a reduction of approximately 16% in non-responders versus
the echo group. In addition to a global favorable effect on long-term heart
failure hospitalization, optimization with SonR resulted in a significant
improvement in clinical response for patients with a history of atrial
fibrillation or renal dysfunction.

"In order to deliver the very best CRT treatment to our heart failure
patients, there has been a real need for an optimization solution that is
both automatic and efficient," said Prof. Josep Brugada, MD, PhD,
Cardiovascular Institute, Hospital Clínic, University of Barcelona, Spain.
"Today the results of the RESPOND-CRT trial have shown that SonR perfectly
meets this need. The high rates of responders together with the beneficial
improvements in clinical outcomes indicate a significant advancement in CRT
therapy, one that will allow us to better treat a larger number of heart
failure patients."

"SonR is a great example of LivaNova's commitment to developing innovative
medical technology that really matters, and we would like to thank the
participating centers and the several independent committees for their great
support in this landmark study," said Stefano Di Lullo, LivaNova, President
of the CRM Business Unit. "The RESPOND-CRT trial results offer our CRM
business a unique growth opportunity while helping physicians treat patients
with heart failure globally."1

About the RESPOND-CRT Trial

The RESPOND-CRT study is a prospective, multicenter, randomized, double-blind
study designed to evaluate the safety and efficacy of the SonR system. The
trial enrolled 1,039 patients at 125 sites in Europe, US and Australia who
were implanted with a CRT-D device. Patients were randomized 2:1 to receive
either AV or VV optimization with SonR or echocardiography. The primary
analyses were performed at 12 months.

The RESPOND-CRT trial is an Investigation Device Exemption (IDE) study
approved by the Food and Drug Administration (FDA).

The study met all of its primary safety and efficacy end points.

The SonRtip lead was proven to be safe, with only 1% of patients reporting
lead dislodgement and 0.1% of patients reporting lead fracture.

Optimization with SonR was proven to be as effective as echo-guided
optimization based on responder rates. Patients were defined as responders at
12 months based on a hierarchical set of criteria as follows: alive, free
from heart failure events, with an improved NYHA functional class or quality
of life. Responder rates were 75% in the SonR arm and 70.4% in the Echo arm
with the P value [P<0.0001] of the non-inferiority test showing that SonR is
as effective as AV and VV echo-guided CRT optimization.

The design of the trial has been published in the American Heart Journal,
2014.2

About SonR contractility sensor

The SonR sensor uses measurements of cardiac contractility in order to
optimize cardiac resynchronization therapy. The SonR cardiac contractility
sensor consists of a micro accelerometer embedded in the tip of the SonRtip
atrial lead. The sensor continuously measures the vibrations generated by
the myocardium during cardiac contractions which are correlated to cardiac
contractility. 3,4,5

The SonRtip lead is connected to a LivaNova CRT-D device featuring an
algorithm which automatically adapts the atrioventricular (AV) and
interventricular (VV) intervals based on cardiac contractility measurements.
Optimization is performed on a weekly basis both at rest and during exercise.
This allows for cardiac resynchronization therapy to be continuously adapted
to the individual needs of each patient.

SonR technology is available exclusively in LivaNova CRT-D devices including
the Paradym, Intensia and Platinium families. The new Platinium CRT-D SonR
device was launched in Europe in November 2015.

References

1 Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, et al. Heart disease
and stroke statistics-2013 update: a report from the American Heart
Association. Circulation. 2013;127:e6-e245
2 Brugada J, Brachmann J, Delnoy PP, et al. Automatic optimization of cardiac
resynchronization therapy using SonR-rationale and design of the clinical
trial of the SonRtip lead and automatic AV-VV optimization algorithm in the
paradym RF SonR CRT-D (RESPOND-CRT) trial. Am Heart J 2014;167:429-36.
3 Rickards AF, Bombardini T, Corbucci G et al. An implantable intracardiac
accelerometer for monitoring myocardial contractility. The multicenter PEA
Study group. Pacing Clin Electrophysiol 1996;19:2066-2071
4 Bongiorni MG, Soldati E, Arena G et al. Local myocardial contractility
related to endocardial acceleration signals detected by a transvenous
pacing lead. Pacing Clin Electrophysiol 1996;19:1682-1688
5 Bordachar P, Garrigue S, Ritter P et al. Contributions of a hemodynamic
sensor embedded in an atrial lead in a porcine model. J Cardiovasc
Elrctrophysiol. 2011;22(5):579-83

About LivaNova

LivaNova PLC 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 4,600 employees
worldwide and is headquartered in London, U.K. With a presence in more than
100 countries, LivaNova operates as three business units: Cardiac Surgery,
Cardiac Rhythm Management, and Neuromodulation, with operating headquarters
in Clamart (France), Mirandola (Italy) and Houston (U.S.), respectively.

LivaNova is listed on NASDAQ and is admitted to the standard listing segment
of the Official List of the UK's Financial Conduct Authority and to trading
on the 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 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 the Company'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
press release are based on information presently available to LivaNova and
assumptions that the Company believes to be reasonable, but are inherently
uncertain. As a result, our 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 and involve known
and unknown risks, uncertainties and other factors that are, in some cases,
beyond the Company's control. Investors are cautioned that all such
statements involve risks and uncertainties, including without limitation,
statements concerning developing novel opportunities in neuromodulation,
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: (i) risks that the legacy businesses of Cyberonics, Inc. and Sorin
S.p.A. (together, the "combined companies") 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; (ii) the inability of
LivaNova to meet expectations regarding the timing, completion and accounting
of tax treatments; (iii) risks relating to unanticipated costs of
integration, including operating costs, customer loss or business disruption
being greater than expected; (iv) our organizational and governance
structure; (v) reductions in customer spending, a slowdown in customer
payments and changes in customer demand for products and services; (vi)
unanticipated changes relating to competitive factors in the industries in
which LivaNova operates; (vii) the ability to hire and retain key personnel;
(viii) the ability to attract new customers and retain existing customers in
the manner anticipated; (ix) the reliance on and integration of information
technology systems; (x) changes in legislation or governmental regulations
affecting LivaNova; (xi) international, national or local economic, social or
political conditions that could adversely affect LivaNova, its partners or
its customers; (xii) conditions in the credit markets; (xiii) business and
other financial risks inherent to the industries in which LivaNova operates;
(xiv) risks associated with assumptions made in connection with critical
accounting estimates and legal proceedings; (xv) LivaNova's interna...

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