Medtronic Announces CE Mark of Evera® Portfolio of Implantable Cardioverter-Defibrillators
MINNEAPOLIS – February 4, 2013 – Medtronic today announced CE (Conformité Européenne) Mark of the Evera® portfolio of implantable cardioverter-defibrillators (ICD). With increased longevity and the most advanced shock reduction technology available, the new family of ICDs is the first to feature the PhysioCurve® design, a contoured shape with thin, smooth edges that better fits inside the body, increasing patient comfort by reducing skin pressure by 30 percent.1 The Medtronic Evera ICD is not approved in the United States.
Building upon its industry-leading device longevity to date (proven by seven independent studies), Medtronic's Evera system delivers up to a 25-percent increase in battery longevity (up to 11 years) compared to previous devices.2,3,4,5,6,7,8,9 In addition, Evera also is paired with the reliable Sprint Quattro® Secure lead, the only ICD lead with 10 years of proven performance with active monitoring.10
"Evera offers patients and physicians a unique standard in modern ICD treatment," said Prof. Joerg O. Schwab, M.D., FESC, FHRS, professor of cardiology at the University Hospital of Bonn, in Bonn, Germany. "With a new shape designed for comfort, greater longevity, the most advanced shock reduction capabilities available on the market, and a best-in-class lead with 10 years of proven reliability, this advanced comprehensive ICD technology works to improve patients' overall quality of life."
Advancing Medtronic's exclusive SmartShock Technology™ – an improved shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms, and delivers a 98-percent inappropriate shock free rate at one year – the Evera system includes SmartShock™ 2.0, the next-generation version of the technology.11 SmartShock 2.0 enhances shock reduction with added performance and simplified programming. Also included in the new ICD portfolio is OptiVol® 2.0 Fluid Status Monitoring and complete diagnostics, which helps to identify patients at risk of worsening heart failure and atrial fibrillation.
"Our new, Evera family of ICDs delivers on our strategy to develop a comprehensive system to reduce many common complications that have been part of receiving an ICD; we have introduced a unique shape to enhance patient comfort, incorporated the most advanced shock reduction technology available, developed a longer-lasting battery than its predecessors, while using the most reliable ICD lead (Sprint Quattro) available," said Marshall Stanton, M.D., vice president and general manager of the tachycardia business at Medtronic. "Patients suffering from debilitating heart rhythm disorders can rely on new treatment options that can significantly improve their quality of life, while adding peace of mind. Evera builds upon 20 years of leadership at Medtronic in driving product innovation and advancements in shock reduction therapy and device longevity."
Numerous studies have found that ICDs improve survival when patients meet evidence-based guidelines. In a recently published analysis in the Journal of the American Medical Association, survival among real-world ICD patients receiving ICDs for primary prevention was similar to patients in two major clinical trials.12
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias.
Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
1 Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file.
2 Knops P, Theuns DA, Res JC, Jordaens L. Analysis of implantable defibrillator longevity under clinical circumstances:implications for device selection. Pacing Clin Electrophysiol. October 2009;32(10):1276-1285.
3 Schaer BA, Koller MT, Sticherling C, Altmann D, Joerg L, Osswald S. Longevity of implantable cardioverterdefibrillators,influencing factors, and comparison to industry-projected longevity. Heart Rhythm. December 2009;6(12):1737-1743.
4 Biffi M, Ziacchi M, Bertini M, et al. Longevity of implantable cardioverter-defibrillators: implications for clinical practice and health care systems. Europace. November 2008;10(12):1288-1295.
5 Kallinen L, et al. 2009. http://spo.escardio.org/eslides/view.aspx?eevtid=33&id=1913.
6 Thijssen J, Borleffs CJ, van Rees JB, et al. Implantable cardioverter-defibrillator longevity under clinical circumstances: an analysis according to device type, generation, and manufacturer. Heart Rhythm. April 2012;9(4):513-519.
7 Shafat T, Baumfeld Y, Novack V, Konstantino Y, Amit G. Significant differences in the expected versus observed longevity of implantable cardioverter defibrillators (ICDs). Clin Res Cardiol. Published online July 14, 2012.
8 Horlbeck FW, Mellert F, Kreuz J, Nickenig G, Schwab JO. Real-world data on the lifespan of implantable cardioverter-defibrillators depending on manufacturers and the amount of ventricular pacing. J Cardiovasc Electrophysiol. December 2012;23(12):1336-1342.
9 Evera XT DR/VR Manual.
10 Medtronic Product Performance Report, 2012 Second Edition, Issue 66.
11 Virtual ICD: A Model to Evaluate Shock Reduction Strategies. Presented at HRS 2010 (P03-125).
12 Al-Khatib SM, Hellkamp A, Bardy GH, et al. Survival of patients receiving a primary prevention implantable cardioverter-defibrillator in clinical practice vs clinical trials. JAMA 2013; 309:55-62