Azure™ Pacing Systems
Azure™ is enabled with BlueSync™ technology, allowing for tablet-based programming and app-based remote monitoring. These devices include exclusive algorithms to manage atrial fibrillation (AF) in pacemaker patients.
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Overview
Conduction System Pacing
A system composed of a SelectSecureTM 3830 MRI lead and a single or a dual chamber Medtronic pacing system is approved for conduction system pacing , which includes His-bundle pacing and left bundle branch area pacing.
Unmatched feature suite
Atrial fibrillation is prevalent and clinically challenging
- 1 in 3 CIED patients will develop new onset AF within the first 2.5 years of implant1
- Increases the risk of heart failure greater than 3-fold2
- 5-fold increase in ischemic stroke risk for AF patients3
Detect
- Highest published AF episode detection accuracy (PPV)*†4-7
- 95-96% AF episode detection accuracy (PPV)5-7
Reduce
- Exclusive algorithms demonstrated to reduce the risk and the duration of AF
- 36% relative reduction in AT/AF episodes > 7 days with Reactive ATP™ Algorithm†8
Reduce unnecessary RV9 pacing with MVP™ feature
- RV pacing is associated with an increased risk of HF hospitalization.10
- RV pacing is associated with a 1% increase in risk of AF for each 1% increase in cumulative RV pacing.10
- MVP algorithm reduces unnecessary RV pacing by 99%.9
Improved longevity
Updated hardware architecture optimizes circuity to reduce current circuitry drain and improve longevity.11
Reimagined connectivity
BlueSync™ technology
BlueSync™ technology within Azure enables secure, wireless communication.
Azure pacemaker engineered with BlueSync™ technology
Monitoring options
Learn more about MyCareLink Heart and other patient monitoring options.
Streamlined workflows
Timely alerts of clinically relevant events12,13
Time to a clinical decision was ~7x faster with the use of Medtronic CareAlert™ notifications compared to standard office follow-up.14
CareAlert™ notifications can be programmed and viewed only by the clinician:
- AT/AF Burden Notification
- Lead Impedance
- Low Battery Voltage @RRT
- VT Episodes
- Fast V. Rate during AT/AF
- Capture Management™
- % V. Pacing
System features
BlueSync™ Technology
MRI SureScan™ Technology
Reactive ATP Algorithm
AF Advantage
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*
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.
†
Detection accuracy is compared using PPV, which is the percentage of all AT/AF episodes detected by the individual device detection algorithm that were adjudicated as true AT/AF.
‡
Projected service life estimates assume device configuration at VVI 50%, 2.5V, 500 Ohm lead impedances, Pre-storage EGM off. Projected service life estimates are based on accelerated battery discharge data and device modeling. The values calculated based on this information should not be interpreted as precise numbers. Individual patient results may vary based on their specific programming and experience.
§
Projected service life estimates assume device configuration at MVP 50% AP, 5% VP, 2.5V in both chambers, 500 Ohm lead impedances, Pre-storage EGM off. Projected service life estimates are based on accelerated battery discharge data and device modeling. The values calculated based on this information should not be interpreted as precise numbers. Individual patient results may vary based on their specific programming and experience.
References
1
Boriani G, Glotzer TV, Ziegler PD, et al. Detection of new atrial fibrillation in patients with cardiac implanted electronic devices and factors associated with transition to higher device-detected atrial fibrillation burden. Heart Rhythm. March 2018;15(3):376-383.
2
Stewart S, Hart CL, Hole DJ, McMurray JJ. 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.
3
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. August 1991;22(8):983-988.
4
Sprenger M. Comparison of Manufacturer’s AT/AF Detection Accuracy across Clinical Studies. Medtronic data on file. January 2015.
5
Pürerfellner 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.
6
Ziegler PD, et al. Accuracy of Atrial Fibrillation Detection in Implantable Pacemakers. Presented at HRS 2013 (PO02-08); Denver, CO.
7
Medtronic data on file. QADoc DSN026170, Version 2.0. “AT/AF Duration Performance Comparison.”
8
Crossley GH, Padeletti L, Zweibel S, Hudnall JH, Zhang Y, Boriani G. Reactive atrial-based antitachycardia pacing therapy reduces atrial tachyarrhythmias. Pacing Clin Electrophysiol. July 2019;42(7):970-979.
9
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); Boston, MA.
10
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.
11
Orenga M. Azure™ longevity increase compared to Advisa™. September 2017. Medtronic data on file.
12
Medtronic Azure™ XT DR MRI SureScan™ Device Manual. M964338A001B. 2016-10-22.
13
Howard K. Alert Notification Timing. September 2017. Medtronic data on file.
14
Crossley GH, Boyle A, Vitense H, Chang Y, Mead RH; CONNECT Investigators. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial: the value of wireless remote monitoring with automatic clinician alerts. J Am Coll Cardiol. March 8, 2011;57(10):1181-1189.
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