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|Medtronic Receives CE Mark for New Single-Chamber ICDs That Can Detect Atrial Fibrillation|
Diagnosing AF with Visia AF(TM) and Visia AF MRI(TM) SureScan® ICDs Enables Physicians to Manage Patients at Increased Risk for Stroke and Heart Failure
DUBLIN - October 21, 2015 - Medtronic plc (NYSE: MDT) today announced it has received CE (Conformité Européenne) Mark for the Visia AF(TM) and Visia AF MRI(TM) SureScan® single-chamber implantable cardioverter defibrillators (ICDs), which can detect and monitor new onset, asymptomatic, and previously undiagnosed atrial fibrillation (AF). Early detection of AF can help a physician better tailor treatment to the needs of the patient. The Visia AF devices include a proprietary algorithm that accurately detects AF episodes, captures AF burden frequency and duration1, and alerts the physician from the patient's home.
An estimated 33 million people worldwide have AF, making it the most common cardiac rhythm disorder in the world.2 AF is a condition that involves an irregular quivering or rapid heart rhythm in the upper chambers (atria) of the heart, and patients with AF are five times more likely to have a stroke3 and three times more likely to have heart failure.4 Approximately 20 percent of patients who experience ventricular arrhythmias (irregular heart rhythms in the lower chambers) later develop AF5, which often goes undetected with traditional external monitors.6-7
Built on the proven performance of the Medtronic Evera(TM) family of ICDs, the Visia AF ICDs also feature a contoured shape with thin, smooth edges that increases patient comfort by reducing skin pressure by 30 percent.8 The devices include the same industry-leading battery longevity (up to 11 years) compared to previous devices.9-16 And when paired with the Sprint Quattro® Secure MRI SureScan® DF4 leads - part of the only ICD lead family with more than 10 years of proven performance with active monitoring17 - the Visia AF MRI SureScan device allows patients to undergo full-body MRI scans.
The Visia AF ICDs include SmartShock(TM) 2.0, an exclusive shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms.18 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.19-22 SmartShock technology helps to eliminate these inappropriate shocks, and delivers a 98 percent inappropriate shock-free rate at one year.23
"Medtronic is committed to continuing to develop a wide range of technologies to help patients with AF," said Marshall Stanton, M.D., vice president and general manager of the Tachycardia business, which is part of the Cardiac Rhythm and Heart Failure division at Medtronic. "With devices like the Visia AF ICDs and the Reveal LINQ(TM) Insertable Cardiac Monitor, which detects and monitors abnormal heart rhythms for up to three years, we aim to increase AF detection and enable physicians to manage a patient's risk for strokes and heart failure."
In the U.S., the Visia AF ICDs are not yet approved for commercial use.
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. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers 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 Medtronic data on file.
2 Chugh SS, Roth GA, Gillum RF, et al. Global Burden of Atrial Fibrillation in Developed and Developing Nations. Global Heart, Vol 9, No. 1, March 2014: 113-119.
3 Wolff PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke the Framingham Study. Stroke. 1991;22 (8): 983-988.
4 Stewart S, Hart CL, Hole DJ, et al. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/ Paisley Study. Am J Med. October 1, 2002;113(5):359-364.
5 Medtronic data on file.
6 Strickberger SA, Ip J, Saksena S, et al. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. 2005;2:125-31.
7 Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. 2006;3:1445-52
8 Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file.
9 Knops P, Theuns DA, Res JC, et al. Analysis of implantable defibrillator longevity under clinical circumstances: implications for device selection. Pacing Clin Electrophysiol. October 2009;32(10):1276-1285.
10 Schaer BA, Koller MT, Sticherling C, et al. Longevity of implantable cardioverter defibrillators, influencing factors, and comparison to industry-projected longevity. Heart Rhythm. December 2009;6(12):1737-1743.
11 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.
12 Kallinen L, et al. 2009. http://spo.escardio.org/eslides/view.aspx?eevtid=33&id=1913.
13 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.
14 Shafat T, Baumfeld Y, Novack V, et al. Significant differences in the expected versus observed longevity of implantable cardioverter defibrillators (ICDs). Clin Res Cardiol. Published online July 14, 2012.
15 Horlbeck FW, Mellert F, Kreuz J, et al. 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.
16 Evera XT DR/VR Manual.
17 Medtronic Product Performance Report, 2012 Second Edition, Issue 66.
18 Volosin KJ, Exner DV, Wathen MS, et al, Combining shock reduction strategies to enhance ICD therapy: a role for computer modeling. J Cardiovasc Electrophysiol. 2011 Mar;22(3):280-9.
19 Daubert JP, Zareba W, Cannom DS, et al. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol. 2008 Apr 8;51(14):1357-65.
20 Kadish A, Dyer A, Daubert JP, et al, for the Defibrillators in Non-Ischemic Cardiomyopathy Treatment Evaluation (DEFINITE) Investigators. Prophylactic defibrillator implantation in patients with nonischemic dilated cardiomyopathy. N Engl J Med. May 20, 2004;350(21):2151-2158.
21 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.
22 Saxon LA, Hayes DL, Gilliam FR, et al. Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study. Circulation. 2010 Dec 7;122(23):2359-67.
23 Auricchio A, Schloss EJ, Kurita T, et al. Low inappropriate shock rates in patients with single and dual/triple chamber ICDs using a novel suite of detection algorithms: PainFree SST Trial Primary Results. Heart Rhythm. 2015 May;12(5):926-36.