SonR(TM): Long Term Clinical Update Confirms Risk Reduction in Heart Failure Hospitalization
(Thomson Reuters ONE) -
RESPOND-CRT landmark trial confirms significant long term risk reduction in
heart failure hospitalization with LivaNova's exclusive SonR sensor-based CRT
optimization system.
LONDON, Aug. 28, 2016 (GLOBE NEWSWIRE) -- LivaNova PLC (NASDAQ:LIVN) (LSE:LIVN)
("LivaNova" or the "Company"), a market-leading medical technology company,
today announced long term results from the RESPOND-CRT clinical trial after an
18 month follow-up period. The results were presented by the principal
investigator, Prof. Josep Brugada, at an oral Clinical Trial Update session
during the annual European Society of Cardiology (ESC) meeting. The RESPOND-CRT
trial was designed to investigate the clinical efficacy and safety of device-
based optimization using LivaNova's proprietary SonR cardiac contractility
sensor technology in patients with advanced heart failure.
Previously, on May 5, 2016, LivaNova announced the RESPOND-CRT one-year results
at the annual Heart Rhythm Society (HRS) and subsequently published a press
release. The one-year data showed that the study met its primary safety and
efficacy end points and demonstrated that SonR was associated with a 35% risk
reduction in heart failure hospitalization.
Automatic optimization with SonR was compared to manual echocardiography guided
optimization. The proprietary SonR optimization system allows for cardiac
resynchronization therapy to be continuously adapted to the needs of each
patient, thus delivering an individualized therapy.
Longer term results, after a complete 18 months patient follow-up, confirmed the
significant risk reduction in heart failure hospitalization on the overall
population enrolled in the study. Additionally, in subgroups of patients with
atrial fibrillation and renal dysfunctions, a 48% and 41% risk reduction in
cardiovascular death or hospitalization was observed with SonR, respectively.
"We are very pleased to observe the consistent long-term clinical benefits of
the SonR optimization system," said Prof. Josep Brugada, MD, PhD, Cardiovascular
Institute, Hospital Clínic, University of Barcelona, Spain. "Reduction of
hospitalization is key for heart failure patients. The impressive improvements
in cardiovascular clinical outcomes for patients with atrial fibrillation or
renal dysfunction show that SonR can treat even better the sicker patients."
"The successful outcomes of the RESPOND-CRT study provides important data that
we are pleased to share with the healthcare community," said Benoît Clinchamps,
LivaNova, Vice President, General Manager CRM. "LivaNova is committed to
developing and delivering safe and effective technology to better treat heart
failure patients. The SonR sensor-based optimization system fully resonates with
this commitment."
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 AV or VV
optimization either with SonR or echocardiography. The primary analyses were
performed at 12 months, secondary analysis were performed at 18 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 [P <0.0001 non-inferiority].
The design of the trial has been published in the American Heart Journal,
2014.(1)
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. (2,3,4)
The SonR tip 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. 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.
2. 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
3. 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
4. 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 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 our 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
LivaNova 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. Investors are
cautioned that all such statements involve risks and uncertainties, including
without limitation, the factors described in the "Risk Factors" section of
LivaNova's Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K, and other documents filed from time to time with, and/or
announced or published pursuant to the rules of, the United States Securities
and Exchange Commission and/or the United Kingdom Financial Conduct Authority by
LivaNova, together with the risk that our internal leadership and organizational
realignment will not lead to intended improvements, efficiency or results. This
list of factors is not exhaustive. LivaNova does not give any assurance (1)
that LivaNova will achieve its expectations, or (2) concerning any result or the
timing thereof.
All information in this press release is as of the date of its release.
LivaNova 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)livanova.com
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq 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
Datum: 28.08.2016 - 20:47 Uhr
Sprache: Deutsch
News-ID 491420
Anzahl Zeichen: 11397
contact information:
Town:
London
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 244 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"SonR(TM): Long Term Clinical Update Confirms Risk Reduction in Heart Failure Hospitalization"
steht unter der journalistisch-redaktionellen Verantwortung von
LivaNova PLC (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
