Medtronic, Inc. : Medtronic Announces CE Mark of Evera® Portfolio of
Next-Generation ICDs Offer Patients Proven Treatment Performance, Increased
Longevity, Improved Comfort
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.^ 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.^^,^^,^^,^^,^^,^^,^^,^ 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.^
"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(TM) - 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(TM) 2.0,
the next-generation version of the technology.^ 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
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
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
Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file.
Knops P, Theuns DA, Res JC, Jordaens L. Analysis of implantable
defibrillator longevity under clinical circumstances:implications for device
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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
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.
Kallinen L, et al. 2009.
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
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
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.
Evera XT DR/VR Manual.
Medtronic Product Performance Report, 2012 Second Edition, Issue 66.
Virtual ICD: A Model to Evaluate Shock Reduction Strategies. Presented at
HRS 2010 (P03-125).
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
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Source: Medtronic, Inc. via Thomson Reuters ONE
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