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Best in class therapy for your brady patients.  AzureTM pacemaker   with BlueSyncTM technology

   

Proven benefits of pacemaker remote monitoring1-2

Boosted with unique BlueSync-enabled ecosystem capabilities5-9

Coupled with the most advanced Medtronic pacemaker11-19 

Pacemaker remote monitoring

“Extensive benefits indicate that RM should not be denied to pacemaker recipients.”1
New Pacing Guidelines include Class I recommendation for remote care to further reduce in-office follow-ups and space them by up to 24 months.2
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CareAlertTM notifications can be programmed and viewed only by the clinician:

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• AT/AF Burden Notification 

• Lead Impedance 

• Low Battery Voltage @RRT 

• VT Episodes  

• Fast V. Rate during AT/AF 

• Capture Management™ 

• % V. Pacing 

BlueSyncTM - enabled ecosystem

High patient compliance & satisfaction with app-based monitoring

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Since MyCareLink Heart launch in 2018, the number of seniors (65+) using smartphones increased from 38% to 54%4. In the meantime, we added more than 150 enhancements to the app and have shown that patients are more compliant and satisfied when using the app. 

Higher compliance results with 3 working days of staff time saved yearly per 100 patients.5

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App is associated with patient satisfaction.6

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Free up clinic time with BeConnected patient support service. 

To help adopt new technology, we assist patients choose and setup their monitoring solution. For those not able to use the app we can ship a monitor directly to their home. 
BeConnected spends 16 min per patient for onboarding and additional 7 min every year answering questions instead of the clinic.7,8 
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Streamlined and secure digital workflow with the SmartSyncTM Device Manager. 

The first programmer offering wireless programming and lead testing capabilities from a distance. 
In-clinic visits using a tablet-based programmer are associated with a 9.6% reduction in staff time, driven by savings in transporting the programmer to the patient room and improved data connectivity with the EHR.9
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The most advanced Medtronic pacemaker10-19

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Improved longevity by 27%10

Improved longevity by 27% compared to previous Medtronic pacemaker platform, thanks to its hardware architecture optimized circuitry.

Reduced unnecessary RV pacing by 99%11

Whilst pacing at an appropriate AV delay for long PR patients with updated MVP™ algorithm. RV pacing is associated with a 1% increase in risk of AF for each 1% increase in cumulative RV apical pacing.12
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36% reduced risk of persistent AF13

With reactive ATP™ feature13**. Atrial ATP is featured in the 2021 ESC guidelines.
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Reduce AT/AF false positive with PR logic™ algorithms14.

azure AF chart

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

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

*** AF detection accuracy rates determined from independent clinical trials are presented for reference.

References

1

Ploux S et. al. Remote monitoring of pacemakers. Archives of Cardiovascular Diseases. 2021.

2

European Heart Journal (2021) 00, 1_94 doi:10.1093/eurheartj/ehab364.

3

Crossley GH, et al. J Am Coll Cardiol. 2011;57:1181-1189.

4

Trust, security and privacy - smartphones (2018) [ISOC_CISCI_SP__custom_3039575] & (2020 onwards) [ISOC_CISCI_SP20__custom_3039578]. Eurostat. 

5

Tarakji K. et al. Impact of a Bluetooth-enabled cardiac device with a patient smartphone app on Clinic efficiency. JACC 2021; Volume 77, Issue 18.

6

Of patients responding to survey. Medtronic data on file. MyCareLink Heart patient satisfaction. February 2021.

7

BeConnected Onboarding Pilot Results - based on 104 patients. December 2020. Medtronic Data on File.

8

BeConnected Day to Day Service - Call Time Analysis. June 2022. Medtronic Data On File.

9

Seiler A et al. JMIR Cardio 2021;5(2):e27720 (based on Van Heel L et al. Circulation 2019;140:A11847 – analysis for all CIED devices from 5 US sites.

10

Orenga M. Azure™ longevity increase compared to Advisa™. September 2017. Medtronic data on file.

11

Gillis AM, et al. Reducing unnecessary right ventricular pacing with the managed ventricular pacing mode in patients with sinus node disease andAV block.PA CE 2006; 29:697–705.

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

Crossley GH, et al. Pacing Clin Electrophysiol. 2019;42:970-979

14

Purerfellner H, et al. Accuracy of Atrial Tachyarrhythmia Detection in Implantable Devices with Arrhythmia Therapies. Pacing Clin Electrophysiol. July 2004;27:983-992.

15

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

16

 Ziegler PD. Accuracy of Atrial Fibrillation Detection in Implantable Pacemakers. Heart Rhythm. 2013;10:S147 [PO 02-08].

17

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

18

Kauffman 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 ASSER T. Heart Rhythm. August 2012;9(8):1241-1246.

19

Nowak B, McMeekin J, Knops M, et al., and on behalf of the Stored EGM in PulsarMax II and Discovery II Study Group. Validation of dual-chamber pacemaker diagnostic data using dual-channel stored electrograms. Pacing Clin Electrophysiol. July 2005;28(7):620-629.

20

Garcia-Fernandez FJ, Osca Asensi J, Romero R, Fernandez Lozano I, Larrazabal JM, Martinez Ferrer J, Ortiz R, Pombo M, Tornes FJ, Moradi Kolbolandi M.  Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE). Eur Heart J  2019;40:1837–1846.

21

Mabo P, Victor F, Bazin P, Ahres S, Babuty D, Da Costa A, Binet D, Daubert JC, COMPAS Trial Investigators. A randomized trial of long-term remote monitoring of pacemaker recipients (the COMPAS trial). Eur Heart J  2012;33:1105–1111.

22

Perl S, Stiegler P, Rotman B, Prenner G, Lercher P, Anelli-Monti M, Sereinigg M, Riegelnik V, Kvas E, Kos C, Heinzel FR, Tscheliessnigg KH, Pieske B.  Socio-economic effects and cost saving potential of remote patient monitoring (SAVE-HM trial). Int J Cardiol  2013;169:402–407.

23

Ricci RP, Morichelli L, Santini M.  Remote control of implanted devices through Home Monitoring technology improves detection and clinical management of atrial fibrillation. Europace  2009;11:54–61.

See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. If using an MRI SureScan™ device, see the MRI SureScan™ technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu. For applicable products, consult instructions for use on www.medtronic.com/manuals. Manuals can be viewed using a current version of any major internet browser. For best results, use Adobe Acrobat® Reader with the browser. Important Reminder: This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use.