LivaNova Launches Next Generation ICD and CRT-D Devices in the United States
LONDON, 2016-09-22 15:30 CEST (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 longevity1thanks 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 depletion2. Replacement procedures are associated with twice as many surgical re-interventions compared to initial implant surgeries due to increased rates of complications, such as infections3. The mortality rate in patients with infections reaches 16.9% at one year and 27.5% at three years4.
The industry-leading longevity1of PLATINIUM has been achieved without compromising the size of the devices. PLATINIUM devices range in size from 31cc to 33cc, and the ErgoformTMdesign 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 SafeRTM, 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.”
1. Medtronic Evera™ XT VR DVBB2D4 Device manual M957115A001A 2014-01-03. Medtronic Evera™ XT DR DDBB2D4 Device manual M957111A001A 2014-01-03. Medtronic Viva™ QUAD XT CRT-D DTBA2QQ Device manual M956933A001A 2013-12-05. Biotronik IperiaTM5/7 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 AutogenTMEL ICD, AutogenTMMini ICD, DynagenTMEL ICD, DynagenTMMini ICD, InogenTMEL ICD, InogenTMMini ICD, OrigenTMEL ICD, OrigenTMMini ICD - Implantable Cardiovertor Defibrillator - 359060-001 EN Europe 2013-04. Boston Scientific - Physician's technical manual AutogenTMCRT-D, AutogenTMX4 CRT-D, DynegenTMCRT-D, DynagenTMX4 CRT-D, InogenTMCRT-D, InogenTMX4 CRT-D, OrigenTMCRT-D, OrigenTMX4 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
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 visitwww.livanova.com, or contact:
Investor Relations and Media
Vice President, Investor Relations & Corporate Communications
Phone: +1 (281) 228-7262
Fax: +1 (281) 218-9332
The new PLATINIUM range of devices featuring the world's longest projected longevity1 will help patients avoid replacement surgeries and associated risks
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