Healthcare Professionals

Azure 

Pacing System for Bradyarrhythmia Management

TRANSFORMING PATIENT MANAGEMENT WITH SMART TECHNOLOGY

  

azure-bluetooth-communicating to mobile devices

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

Azure Key Design changes artwork

*NIST: National Institute of Standards and Technology.

SMART PATIENT MANAGEMENT

Smart Patient Management

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.

  • Patients can now use their smartphones* to transfer heart device data via MyCareLink Heart™ mobile app – even outside the home – replacing the bedside monitor.
  • Patients can now view select pacemaker data, including model name and battery longevity.

The MyCareLink Heart™ mobile App has been designed to enhance:

  • Patient compliance, leading to increased clinic efficiency 14
  • Patient engagement, promoting patient satisfaction 15
  • Patient access to newest technology due to ease of app upgrades

bluesync-flow-chart-illustration
bluesync-enabled-devcies-illustration

*Visit www.MCLHeart.com  for a list of compatible smartphones and tablets 

SECURITY MEASURES

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.

PACEMAKER PROTECTION

  • Pacemaker doesn’t accept programming from unauthorized sources. It only accepts programming from Medtronic programmers in close proximity.
  • Device is not connected to the Internet and does not have an IP address

DATA PRIVACY

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

 

IMPROVED LONGEVITY

 

New hardware architecture optimizes circuitry to reduce current drain and improve longevity.2

Improved Longevity chart

*Bluetooth® Low Energy: ON: 500 ohm; 2.5V; pre-storage EGM: OFF; DR:MVP™ ;SR: VVI 50%

AF DETECTION & REDUCTION

DETECT AF

Reduce AT/AF false positives with PR Logic™algorithms.

 

 Graph of Accurate AF Detection

*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.

2090-programmer-picture

Wireless alerts can now be transmitted via Bluetooth using the MyCareLink Heart™ mobile app, providing patient monitoring — even outside the home.

TIMELY ALERTS
FOR CLINICALLY
RELEVANT EVENTS1,3

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
  • Optivol™

REDUCE AF

Reduce Duration of AF with Reactive ATP

  • Reactive ATP™ provides an opportunity to terminate an ongoing AF episode by delivering ATP during those times when the rhythm has organised and/or slowed.
  •  An analysis of 8,032 patients in the Medtronic CareLink™ database assessed the impact of Reactive ATP across pacemakers, ICDs, and CRT devices.7

 Reactive ATP is associated with a reduction in the duration of AT/AF graphic

*Compared to matched control group; matched components included age, sex, baseline AF and percent VP, pacing mode, and device type.

Learn more in this informative video as CRHF Chief Medical Officer, Dr. Rob Kowal, discusses the data.

AAI(R) to DDD(R) flowchart

Reduce Unnecessary RV Pacing with MVP™ 11

Now updated with the option to control maximum AV interval

  • RV pacing is associated with an increased risk of HF hospitalization.12
  • RV pacing is associated with a 1% increase in risk of AF for each 1% increase in cumulative RV pacing.12
  • MVP algorithm reduces unnecessary RV pacing by 99%.11

UNMATCHED MRI ACCESS

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

MODEL SPECIFICATIONS

Azure MRI SureScan Specifications Sheets

Device Model Number Asset

Azure ™XT DR MRI SureScan

W2DR01

Download Spec Sheet

Azure™ S DR MRI SureScan™

W3DR01

Download Spec Sheet

Azure™  XT SR  MRI SureScan™ 

W2SR01

Download Spec Sheet

Azure™ S SR MRI SureScan

W3SR01

Download Spec Sheet

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.

1

Medtronic Azure XT DR MRI SureScan Device Manual.

2

Orenga M. Azure longevity Increase Compared to Advisa. September 2017. Medtronic data on file.

3

Howard K. Alert Notification Timing. September 2017. Medtronic data on file.

4

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.

5

Ziegler PD, et al. Accuracy of Atrial Fibrillation Detection in Implantable Pacemakers. Presented at HRS 2013 (PO02-08).  

6

Medtronic Data on File. QADoc DSN026170, Version 2.0, “AT/AF Duration Performance Comparison.

7

Hudnall H. Reactive Atrial-based Antitachycardia Pacing Therapy to Slow Progression of Atrial Fibrillation. August 2017, Medtronic data on file.

8

Sprenger M. Comparison of Manufacturer's AT/AF Detection Accuracy across Clinical Studies. January 2015. Medtronic data on file.

9

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.

10

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.

11

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).

12

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.

13

M964377A001 Azure™ MRI SureScan™/Astra™ MRI SureScan™ pacing systems MRI Technical Manual.

14
Cronin EM, Ching EA, Varma N, Martin DO, Wilkoff BL, Lindsay BD. Remote monitoring of cardiovascular devices: a time and activity analysis. Heart Rhythm. December 2012;9(12):1947-1951.

15

Varma N. Cont Cardiol Educ. 2016;2:198-204