Pacing System for Bradyarrhythmia Management
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Pacing System for Bradyarrhythmia Management
The Azure™ pacemaker is completely redesigned for secure1 wireless communication via Bluetooth® Low Energy without compromising longevity2. BlueSync™ Technology enables Azure to communicate directly with a patient-owned mobile platform.
Azure also offers timely alerts for clinically relevant events1,3 with accurate AF detection4,5,6 and exclusive features proven to reduce the risk of onset and duration of AF.7
*NIST: National Institute of Standards and Technology.
Innovation in consumer digital tools is creating new opportunities in healthcare. BlueSync™ technology allows Medtronic to innovate and connect with patients and clinicians in new and exciting ways.
The MyCareLink Heart™ mobile App has been designed to enhance:
*Visit www.MCLHeart.com for a list of compatible smartphones and tablets
Security for Bluesync™ technology was designed to protect the device, patient data and connectivity. In addition to Medtronic's extensive internal product security testing, Medtronic has also engaged with outside specialized security testing firms.
Data are encrypted in the pacemaker using NIST government standard for security (used in critical applications like banking) before they are transmitted to CareLink network via the app
New hardware architecture optimizes circuitry to reduce current drain and improve longevity.2
*Bluetooth® Low Energy: ON: 500 ohm; 2.5V; pre-storage EGM: OFF; DR:MVP™ ;SR: VVI 50%
Reduce AT/AF false positives with PR Logic™4 algorithms.
*A controlled head-to-head study evaluating the comparative performance of device algorithms has not been done. AF detection accuracy rates determined from independent clinical trials are presented for reference.
CareAlert™ notifications can be programmed and viewed only by the clinician:
Reduce Duration of AF with Reactive ATP
*Compared to matched control group; matched components included age, sex, baseline AF and percent VP, pacing mode, and device type.
Reduce Unnecessary RV Pacing with MVP™ 11
Now updated with the option to control maximum AV interval
With Azure, patients have access to 1.5T and 3T full body scanning.13 For a complete list of approved device and lead combinations, please visit www.mrisurescan.com.
The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license.
Medtronic Azure XT DR MRI SureScan Device Manual.
Orenga M. Azure longevity Increase Compared to Advisa. September 2017. Medtronic data on file.
Howard K. Alert Notification Timing. September 2017. Medtronic data on file.
Purerfellner H, Gillis AM, Holbrook R, Hettrick DA. Accuracy of atrial tachyarrhythmia detection in implantable devices with arrhythmia therapies. Pacing Clin Electrophysiol. July 2004;27(7):983-992.
Ziegler PD, et al. Accuracy of Atrial Fibrillation Detection in Implantable Pacemakers. Presented at HRS 2013 (PO02-08).
Medtronic Data on File. QADoc DSN026170, Version 2.0, “AT/AF Duration Performance Comparison.
Hudnall H. Reactive Atrial-based Antitachycardia Pacing Therapy to Slow Progression of Atrial Fibrillation. August 2017, Medtronic data on file.
Sprenger M. Comparison of Manufacturer's AT/AF Detection Accuracy across Clinical Studies. January 2015. Medtronic data on file.
Kaufman ES, Israel CW, Nair GM, et al. Positive predictive value of device-detected atrial high-rate episodes at different rates and durations: an analysis from ASSERT. Heart Rhythm. August 2012;9(8):1241-1246.
Nowak B, McMeekin J, Knops M, et al. Validation of dual-chamber pacemaker diagnostic data using dual-channel stored electrograms. Pacing Clin Electrophysiol. July 7, 2005;28(7):620-629.
Gillis AM, et al. Reduction of unnecessary right ventricular pacing due to the managed ventricular pacing (MVP) mode in patients with symptomatic bradycardia. Benefit for both Sinus node disease and AV block indications. Presented at HRS 2015 (Abstract AB21-1).
Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. June 17, 2003;107(23):2932-2937.
M964377A001 Azure™ MRI SureScan™/Astra™ MRI SureScan™ pacing systems MRI Technical Manual.
Varma N. Cont Cardiol Educ. 2016;2:198-204