Pacemakers

Azure™ MRI SureScan™ pacemaker

<p>The Azure™ MRI SureScan™ pacemaker manages atrial fibrillation (AF) in pacemaker patients with tablet-based programming and app-based remote monitoring.</p>

Ordering information
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Features

Detects AF episodes

  • Highest published AF episode detection accuracy (PPV)†,‡,4–7

  • 95–96% AF episode detection accuracy (PPV)5–7

Reduces AF risk and duration

  • 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

Reduces unnecessary RV9 pacing with the MVP™ feature

  • Right-ventricular (RV) pacing is associated with an increased risk of heart failure (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

Improves device longevity

Updated hardware architecture optimizes circuity to reduce current circuitry drain and improve longevity.11

Reimagined connectivity with BlueSync™ technology

BlueSync™ technology within Azure™ enables secure, wireless communication.

CareLink SmartSync™ interface shown on tablet

Tablet-based CareLink SmartSync™ device manager

Product image of the Azure™ MRI SureScan™ pacemaker with BlueSync™ icon on white background

Azure™ pacemaker engineered with BlueSync™ technology 

MyCareLink Heart™ app and MyCareLink Relay™ home communicator on white background

MyCareLink Heart™ mobile app or MyCareLink Relay™ Home Communicator

Get Connected™ service shown on desktop monitor

CareLink™ network and the
Get Connected™ service

Streamlined workflows

Timely alerts of clinically relevant events12,13

Time to a clinical decision was about seven times 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 at recommended replacement time (RRT)

  • VT episodes

  • Fast ventricular rate (VR) during AT/AF

  • Capture Management™

  • Percentage ventricular pacing

Clinicians can stay connected with Azure™ pacemaker patients with CareAlert ™ notifications.

Ordering information

 

Item number Description Mass (g) Volume (mL) Size — height × width × depth (mm) Connector
W3DR01 Azure™ S DR MRI SureScan™ pacemaker 22.5 12.75 46.6 × 50.8 × 7.4 IS-1 BI/UNI
W3SR01 Azure™ S SR MRI SureScan™ pacemaker 22.5 12.25 42.6 × 50.8 × 7.4 IS-1 BI/UNI
W2DR01 Azure™ XT DR MRI SureScan™ pacemaker 22.5 12.75 46.6 × 50.8 × 7.4 IS-1 BI/UNI
W1SR01 Azure™ XT SR MRI SureScan™ pacemaker 22.5 12.25 42.6 × 50.8 × 7.4 IS-1 BI/UNI

Resources

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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.

  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. 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. 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. 1991;22(8):983–988.

  1. Sprenger M. Comparison of manufacturer’s AT/AF detection accuracy across clinical studies. Medtronic data on file. January 2015.
  2. Pürerfellner H, Gillis AM, Holbrook R, Hettrick DA. Accuracy of atrial tachyarrhythmia detection in implantable devices with arrhythmia therapies. Pacing Clin Electrophysiol. 2004;27(7):983–992.
  3. Ziegler PD, et al. Accuracy of Atrial Fibrillation Detection in Implantable Pacemakers. Presented at HRS 2013 (PO02-08); Denver, CO.
  4. Based on internal test report QADoc DSN026170, version 2.0. AT/AF duration performance comparison.
  5. Crossley GH, Padeletti L, Zweibel S, Hudnall JH, Zhang Y, Boriani G. Reactive atrial-based antitachycardia pacing therapy reduces atrial tachyarrhythmias. Pacing Clin Electrophysiol. 2019;42(7):970–979.
  6. Gillis AM, Pürerfellner H, Israel CW, 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.
  7. 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. 2003;107(23):2932–2937.
  8. Orenga M. Azure™ longevity increase compared to Advisa™. September 2017. Medtronic data on file.
  9. Medtronic Azure™ XT DR MRI SureScan™ device manual, M964338A001B. 2016-10-22.
  10. Howard K. Alert notification timing. September 2017. Medtronic data on file.
  11. 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. 2011;57(10):1181–1189.