LivaNova Launches Next Generation ICD and CRT-D Devices in the United States

LivaNova PLC has launched 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 technology and optimized manufacturing processes which ensure extremely low energy consumption. The service life is projected to last more than 14 years for the single-chamber ICD, more than 13 years for the dual-chamber ICD and more than 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 in 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 percent at one year and 27.5 percent at three years.⁴
 
The longevity¹ of PLATINIUM has been achieved without compromising the size of the devices. PLATINIUM devices range in size from 31 cc to 33 cc, and the ErgoformTM 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 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’s vice president and general manager of CRM. “PLATINIUM addresses the medical community requests in closing the gap between patient life expectancy and device service life.”

LivaNova PLC is a global medical technology company formed by the merger of Sorin S.p.A, a developer of cardiovascular disease treatment, and Cyberonics Inc., a medical device company with core expertise in neuromodulation. The Company employs approximately 4,600 employees worldwide and is headquartered in London, United Kingdom. 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, Texas, respectively.
 
References
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 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, DynegenTM 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. 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