LivaNova: Miscellaneous
(Thomson Reuters ONE) -
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 international operations, which are subject to the risks of currency
fluctuations and foreign exchange controls; (xvi) 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 Company's business, including those described in the "Risk Factors" section
of Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports
on Form 8-K, the Registration Statement on Form S-4 and other documents filed
from time to time with the United States Securities and Exchange Commission by
LivaNova. 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.
All information in this press release is as of the date of its release. The
Company does not undertake or assume any obligation to update publicly any of
the forward-looking statements in this press 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 press release.
For more information, please visit www.livanova.com, or contact:
Investor Relations and Media:
Karen King
Vice President, Investor Relations & Corporate Communications
Phone: +1 (281) 228-7262
Fax: +1 (281) 218-9332
e-mail: corporate.communications(at)lilvanova.com
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Source: LivaNova plc via GlobeNewswire
[HUG#2010220]
Datum: 05.05.2016 - 18:45 Uhr
Sprache: Deutsch
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