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SonR: 35% Risk Reduction in Heart Failure Hospitalization

Failure Hospitalization


LONDON, 2016-05-05 18:50 CEST (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.


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) Liv...

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