LivaNova Launches Next Generation ICD and CRT-D Devices in the United States
(Thomson Reuters ONE) -
The new PLATINIUM range of devices featuring the world's longest projected
longevity(1 )will help patients avoid replacement surgeries and associated risks
LONDON, Sept. 22, 2016 (GLOBE NEWSWIRE) -- LivaNova PLC (NASDAQ:LIVN) (LSE:LIVN)
("LivaNova" or the "Company"), a market-leading medical technology company,
announced today the launch of PLATINIUM, its next-generation range of
implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy
devices (CRT-Ds). PLATINIUM models offer unmatched longevity(1) thanks to
LivaNova's breakthrough technology and optimized manufacturing processes which
ensure extremely low energy consumption. The service life is projected to last
over 14 years for the single-chamber ICD, over 13 years for the dual-chamber ICD
and over 10 years for CRT-D devices.
"Increasing the longevity of ICD and CRT-D devices is crucial for patients to
avoid early replacement surgeries, which carry risks of complications and
increase the cost of care," said Dr. Steven Kutalek, M.D., FACC, FHRS, Drexel
University College of Medicine, Philadelphia, PA. "Longevity needs to be a
primary consideration when selecting a device for a patient. I welcome the
launch of LivaNova's PLATINIUM devices. They represent a significant
improvement in medical technology, combining superb arrhythmia detection and
discrimination algorithms with excellent battery longevity."
More than one third of patients implanted with an ICD or a CRT-D will require at
least one replacement due to battery depletion(2). Replacement procedures are
associated with twice as many surgical re-interventions compared to initial
implant surgeries due to increased rates of complications, such as
infections(3). The mortality rate in patients with infections reaches 16.9% at
one year and 27.5% at three years(4).
The industry-leading longevity(1) of PLATINIUM has been achieved without
compromising the size of the devices. PLATINIUM devices range in size from
31cc to 33cc, and the Ergoform(TM) design of the can, with its rounded shape and
smooth edges is designed to facilitate implant procedures and improve patient
comfort. PLATINIUM devices also feature proven therapeutic functions such as
PARAD+(TM), a best-in-class arrhythmia discrimination algorithm, and SafeR(TM),
a pacing mode which preserves natural heart conduction.
"The technology we have developed will provide U.S. physicians and patients a
broader range of devices offering the longest projected longevity of any on the
market," said Benoît Clinchamps, LivaNova, Vice President, General Manager CRM.
"PLATINIUM addresses the medical community requests in closing the gap between
patient life expectancy and device service life. LivaNova is committed to
health innovation that matters and PLATINIUM devices reaffirm this commitment."
References
1. Medtronic Evera(TM) XT VR DVBB2D4 Device manual M957115A001A 2014-01-03.
Medtronic Evera(TM) XT DR DDBB2D4 Device manual M957111A001A 2014-01-03.
Medtronic Viva(TM) QUAD XT CRT-D DTBA2QQ Device manual M956933A001A 2013-12-05.
Biotronik Iperia(TM) 5/7 VR-T, VR-T DX, DR-T, HF-T, HF-T QP (ProMRI®) Technical
Manual 403736 Revision: B (2014-11-19). Saint Jude Medical - Bradycardia and
Tachycardia Devices - Help Manual - June 2013 Art 60033180/A. Boston Scientific
- Physician's technical manual Autogen(TM) EL ICD, Autogen(TM) Mini ICD,
Dynagen(TM) EL ICD, Dynagen(TM) Mini ICD, Inogen(TM) EL ICD, Inogen(TM) Mini
ICD, Origen(TM) EL ICD, Origen(TM) Mini ICD - Implantable Cardiovertor
Defibrillator - 359060-001 EN Europe 2013-04. Boston Scientific - Physician's
technical manual Autogen(TM) CRT-D, Autogen(TM) X4 CRT-D, Dynegen(TM) CRT-D,
Dynagen(TM )X4 CRT-D, Inogen(TM )CRT-D, Inogen(TM) X4 CRT-D, Origen(TM)CRT-D,
Origen(TM) X4 CRT-D Cardiac resynchronization therapy Defibrillator 359059-019
EN Europe 2013-04.
2. Ramachandra I. Impact of ICD battery Longevity on Need for Device
Replacements-Insight from Veterans Affairs Database. PACE 2010; 33:314-319.
3. Borleffs CJW, Thijssen J, Mihaly K et al. Recurrent Implantable Cardioverter-
Defibrillator Replacement Is Associated with Increasing Risk of Pocket-Related
Complications. Pacing Clinical electrophysiol 2013;33:1013-19.
4. De Bie MK, Van Rees JB, Thijssen J et al. Cardiac device infections are
associated with a significant mortality risk. Heart Rhythm; Vol 9, 2011: 494-8
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
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new information or future events, changes in assumptions or changes in other
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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: 22.09.2016 - 15:30 Uhr
Sprache: Deutsch
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