LivaNova PLC Press Release

LivaNova Announces the Launch of the PLATINIUM ICD & CRT-D Family Providing the World’s Longest Projected Longevity

PLATINIUM, released simultaneously in both Europe and Japan by LivaNova (formerly Sorin Group), will protect patients from avoidable replacement surgeries and the inherent risk of complications.
LONDON–(BUSINESS WIRE)–Nov. 2, 2015– LivaNova PLC, (NASDAQ:LIVN) (LSE:LIVN), a leading global medical technology company, is proud to announce the commercial launch of PLATINIUM, a new range of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-Ds*).
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Platinium

Platinium, a new range of implantable cardiac defibrillators and CRT-D devices (Photo: Business Wire)

PLATINIUM offers unmatched longevity1 thanks to a breakthrough technology that ensures extremely low electrical intrinsic consumption. In standard functioning conditions, the service life is projected to last over 14 years for the single-chamber ICD model, over 13 years for the dual-chamber ICD model, and over 10 years for CRT-D devices.
More than 60% of patients are under 70 years of age at the time of their first implant2, and more than one third will require at least one replacement due to battery depletion3. Replacement procedures are associated with twice as many surgical re-interventions as compared to de-novo procedures due to increased rates of complications, such as infections4. The mortality rate in patients with an infection reaches 16.9% at 1 Year and 27.5% at 3 Years5.
The outstanding longevity of PLATINIUM aims to limit the number of device replacements, minimizing the risks that are inherent in replacement surgeries. The industry-leading longevity1 of PLATINIUM has been achieved without compromising the size of the device. PLATINIUM’s size ranges from 31cc to 33cc, and the ErgoformTM design of the can, with its rounded shape and smooth edges was designed to facilitate the implant procedure and improve patient comfort. PLATINIUM devices also feature proven therapeutic functions such as PARAD+TM, a best-in-class arrhythmia discrimination algorithm, SafeRTM, a pacing mode which preserves natural heart conduction and SonRTM, the only hemodynamic sensor which automatically optimizes CRT settings. “It’s clear that there is a growing mismatch between patient life expectancy and the longevity of ICD and CRT-D devices”, said Dr Philippe Ritter, M.D., Hôpital Cardiologique du Haut Levêque,University of Bordeaux, France. “This leads to a very high rate of replacement which can generate major complications for patients and significant associated costs. This is a serious issue for patients and PLATINIUM, with an expected service life of over 14 years, addresses this gap.” “With PLATINIUM we are definitively entering a new era for ICD and CRT-D devices. PLATINIUM’s unsurpassed longevity1 will benefit all patients, both those who, thanks to the efforts of the medical community, are living longer as well as those who are receiving their first device at a younger age”, said Stefano Di Lullo, LivaNova, President of the CRM Business Unit. “PLATINIUM’s outstanding longevity together with its small size and proven therapeutic features reflect our commitment to developing breakthrough technologies that provide the very best care to patients”.

References

*CRT-D and SonR CRT-D models are not yet available for sale or distribution in Japan.

  1. Medtronic EVERA™ XT VR DVBB2D4 Device manual M957115A001A 2014- 01-03. Medtronic EVERA™ XT DR DDBB2D4 Device manual M957111A001A 2014-01-0. Medtronic VIVA™ QUAD XT CRT-D DTBA2QQ Device manual M956933A001A 2013-12-05. Biotronik IPERIATM 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 AUTOGENTM EL ICD, AUTOGENTM MINI ICD, DYNAGENTM EL ICD, DYNAGENTM MINI ICD, INOGENTM EL ICD, INOGENTM MINI ICD, ORIGENTM EL ICD, ORIGENTM MINI ICD – Implantable Cardiovertor Defibrillator – 359060-001 EN Europe 2013- 04. Boston Scientific – Physician’s technical manual AUTOGENTM CRT-D, AUTOGENTM x4 CRT-D, DYNAGENTM CRT-D, DYNAGENTM X4 CRT-D, INOGENTM CRT-D, INOGENTM X4 CRT-D, ORIGENTM CRT-D, ORIGENTM x4 CRT-D Cardiac resynchronization therapy Defibrillator 359059-019 EN Europe 2013-04.
  2. Swedish ICD and Pacemaker Registry – Annual statistical report 2014. www.pacemakerregistret.se/
  3. Ramachandra I. Impact of ICD battery Longevity on Need for Device Replacements-Insight from Veterans Affairs Database. PACE 2010; 33:314-319.
  4. 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.
  5. 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, headquartered in London, UK, 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 aims to transform medical innovation into meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems. The company employs approximately 4,500 employees worldwide. With a presence in more than 100 countries,LivaNova operates as three business units: Cardiac Rhythm Management, Cardiac Surgery, and Neuromodulation, with operating headquarters in Clamart (France), Mirandola (Italy) and Houston (U.S.A.), respectively. LivaNova is listed on the NASDAQ stock exchange and 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 Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology, including “may,” “believe,” “will,” “expect,” “anticipate,” “estimate,” “plan,” “intend,” “forecast,” or other similar words. Statements contained in this press release are based on information presently available to LivaNova and assumptions that the parties believe to be reasonable. LivaNova is not assuming any duty to update this information if those facts change or if the assumptions are no longer believed to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning developing novel opportunities in 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: risks that the new businesses 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; the inability of LivaNova to meet expectations regarding the timing, completion and accounting and tax treatments; risks relating to unanticipated costs of integration, including operating costs, customer loss or business disruption being greater than expected; reductions in customer spending, a slowdown in customer payments and changes in customer demand for products and services; unanticipated changes relating to competitive factors in the industries in which the company operates; the ability to hire and retain key personnel; the ability to attract new customers and retain existing customers in the manner anticipated; reliance on and integration of information technology systems; changes in legislation or governmental regulations affecting the company; international, national or local economic, social or political conditions that could adversely affect the company or its customers; conditions in the credit markets; risks to the industries in which LivaNova operates that are described in the “Risk Factors” section of the Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other documents filed from time to time with the SEC byCyberonics, Inc. and LivaNova and the analogous section in annual reports and other documents filed from time to time by Sorin S.p.A. with the Italian financial market regulator (CONSOB); risks associated with assumptions made in connection with critical accounting estimates and legal proceedings; LivaNova’s’ international operations, which are subject to the risks of currency fluctuations and foreign exchange controls; 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 parties’ businesses, including those described in Cyberonics’ Annual Report on Form 10-K, as amended from time to time, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other documents filed from time to time with theSEC by Cyberonics and LivaNova and those described in Sorin’s annual reports, registration documents and other documents filed from time to time with CONSOB by Sorin. 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. For more information, please visit www.livanova.com