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|Medtronic Announces Japanese Approval and Launch of Implantable Cardioverter-Defibrillator System to Allow for Full-Body MRI Scans|
Evera MRI(TM) ICD System Combines Proven Treatment Performance, Increased Longevity
MINNEAPOLIS - Nov. 10, 2014 - Medtronic today announced Japanese regulatory approval and launch of the Evera MRI(TM) SureScan® implantable cardioverter-defibrillator (ICD) System for magnetic resonance imaging (MRI) scans positioned on any region of the body. Reimbursement also was approved by Japan's Ministry of Health, Labor and Welfare (MHLW). The Medtronic Evera MRI ICD is currently limited to investigational use in the United States.
It is estimated that more than half of ICD patients will need an MRI within 10 years of receiving a device.1 Until the availability of MR-Conditional ICD systems, patients with devices have been contraindicated from receiving MRI scans because of potential interactions between the MRI and device function.
The newly-approved Evera MRI device is available in both single chamber and dual chamber ICDs. Like its non-MR-Conditional predecessor, the Evera MRI features a contoured shape with thin, smooth edges that better fits inside the body, increasing patient comfort by reducing skin pressure by 30 percent.2 The Evera MRI maintains the same industry-leading battery longevity (up to 11 years) compared to previous devices.3,4,5,6,7,8,9,10 In addition, Evera MRI is paired with the Sprint Quattro® Secure family of ICD leads, which has 10 years of proven performance with active monitoring11 and is safe for use in an MRI environment.12
Evera MRI includes SmartShock(TM) 2.0 - an exclusive shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms. While the majority of shocks delivered are necessary to treat potentially fatal arrhythmias, studies estimate that approximately 20 percent of patients with implantable defibrillators may experience inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device.13 SmartShock technology helps to eliminate these inappropriate shocks, and delivers a 98-percent inappropriate shock free rate at one year.14,15 Also included in the Evera MRI is OptiVol® 2.0 Fluid Status Monitoring and complete diagnostics, which helps to identify patients at risk of worsening heart failure and atrial fibrillation.
"This means that in addition to having the highest standard in modern ICD treatment, patients implanted with an Evera MRI defibrillator will now have improved access to one of the most important diagnostic tools - the MRI," said Marshall Stanton, M.D., vice president and general manager of the Tachycardia Business at Medtronic. "Compared to other ICDs available, the Evera MRI system gives patients the most unrestricted access to MRI scans, and ultimately allows them to get the diagnostic answers they need."
The Evera MRI system is the latest addition to a growing number of Medtronic devices which are designed for MRI access including the Medtronic SureScan® pacing systems, neurostimulation systems for the management of chronic pain and the SynchroMed® II programmable drug infusion system.
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.
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 Turakhia M, Reynolds M, Wolff S, et al. Medtronic Data on File 2013. Data from 2011 MarketScan® Commercial and Medicare database, Truven Analysis, Inc. were used for this research. Patient cohort represents ICD patients in terms of age, gender, and major comorbidities (N = 10,778).
2 Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file.
3 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.
4 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.
5 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.
6 Kallinen L, et al. 2009. http://spo.escardio.org/eslides/view.aspx?eevtid=33&id=1913.
7 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.
8 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.
9 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.
10 Evera XT DR/VR Manual.
11 Medtronic Product Performance Report, 2012 Second Edition, Issue 66.
12 Models 6935M (55cm, 62cm) and 6947M (55cm, 62cm)
13 Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med. 2008 Sep 4;359(10):1009-17. Doi: 10.1056/NEJMoa071098.
14 E.J. Schloss et al. Painfree sst trial primary results low shock rates in patients with dual and triple chamber icd's using novel detection algorithms late breaking clinical
15 Meijer et al PainFree SmartShock technology: Trial primary results: Inappropriate shock rates in patients with single chamber ICD's using a novel suite of detection