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Nov 02, 2015

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, UK, November 2nd, 2015 LivaNova PLC, (NASDAQ, 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*).

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. https://www.pacemakerregistret.se/icdpmr/start.do

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”.

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