Transforming paTienT managemenT with smart technology

Improved Longevity1

Smart Patient Management

AF Detection and Reduction2

Transforming paTienT managemenT with smart technologyAzure™ Pacemaker with BlueSync™ Technology

High Density Integrated Circuit reduces current drain for improved longevity

Bluetooth® Low Energy (BLE)

Encryption Module Data are encrypted in the pacemaker using nisT* standard encryption

Key Design Changes

Detect AF Reduce AF

new PlatForm WiTH BLUesYnC TeCHnoLogY

imProVeD LongeViTY

smart paTienT managemenT

aF Detection anD reDUCTion

MyCareLink Heart mobile App on patient's smartphone

Bluesync™ technology enables secure wireless communication via Bluetooth® low energy without compromising longevity.

Introducing Azure with BlueSync™ Technology, the first pacemaker that connects with a smartphone or tablet without compromising longevity and building on best in class AF detection and reduction.

patient compliance, leading to increased clinic efficiency3

mVP Now updated with the option to control maximum AV interval

mVp algorithm reduces unnecessary rV pacing by 99%.15

rV pacing is associated with a 1% increase in risk of af for each 1% increase in cumulative rV apical pacing.16

Reactive ATP is associated with a 40% reduced risk of persistent AF2**

* af detection accuracy rates determined from independant clinical trials are presented for reference

patient engagement, promoting patient satisfaction4

Patient access to newest technology due to ease of app upgrades

new hardware architecture optimises circuitry to reduce current drain and improve longevity.

myCareLink Heart™ mobile app has been designed to enhance:

Azure offers AF detection and reduction algorithms with clinically proven efficiency.

af episode Detection accuracy (ppV)10*

Reduce AT/AF false positives with PR Logic™9 algorithms

Reactive ATP™

* Bluetooth® Low energy: on; 500 ohm; 2.5 V; pre-storage egm: off; Dr: mVp™; sr: VVi 50%.* nisT: national institute of standards and technology (Us Department of Commerce).

*please visit www.mCLHeart.com for a list of compatible smartphones and tablets. ** mVp is only available in Dr models. reactive aTp is only available in azure XT Dr.

MyCareLink Heart mobile App on patient’s smartphone*

Azure with BlueSync Technology

CareLink™ network

(acts as a pass-through only)

Cellular or Wi-fi

(content of transmissions and alerts are not visible to the patient)

select data

Advisa DR MRITm Azure DR

10.8 years*

13.7 years*

+27%

DR 13.7YEARS 5,6*

SR 15.8YEARS 7,8*

40%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Medtronic St. Jude Medical Boston Scientific

AV conduction2:1 or greaterfor a minimum of 24 V cycles(~20sec) A Rate > 190 bpm

Episodes ≤6 minutes

A Rate > 170 bpm4 A cycles

Episodes> 6 Minutes

95-96%9, 11, 12

83%13

48%13

62%14

With Azure™ Pacemaker, patients have access to 1.5T and 3T full body scanning16

Built to be scanned§ our surescan™ devices and leads work

in any combination.

§ scanning conditions are simple: no mri exclusion zone, no patient height restriction, no mri duration restriction.16

UnmatcheD mri aCCess

Brief Statementsee the mri surescan® manual before performing an mri scan and the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. for further information, contact your local medtronic representative and/or consult the medtronic website at www.medtronic.com.

Consult instructions for use at this website. manuals can be viewed using a current version of any major internet browser. for best results, use adobe acrobat reader® with the browser.

all rights reserved. medtronic, medtronic logo, and further, Together are trademarks of medtronic. 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.™ other third party brands are trademarks of their respective owners. all other brands are trademarks of a medtronic company.

References1 orenga m. azure longevity increase Compared to advisa. september

2017. medtronic data on file.2 Hudnall H. reactive atrial-based antitachycardia pacing Therapy to slow

progression of atrial fibrillation. august 2017, medtronic data on file.3 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.

4 Varma n. remote monitoring of patients with CieDs following the updated recommendations — easing or adding to postimplant responsibilities? Cont. Cardiol educ. December 2016;2(4):198-204.

5 m964362a001 C azure™ XT Dr mri surescan™ W2Dr01. Device manual.

6 m964363a001 B azure™ s Dr mri surescan™ W3Dr01. Device manual.7 m964364a001 B azure™ XT sr mri surescan™ W2sr01. Device

manual.8 m964365a001 B azure™ s sr mri surescan™ W3sr01. Device manual.9 purerfellner H, et al. accuracy of atrial Tachyarrhythmia Detection

in implantable Devices with arrhythmia Therapies. pacing Clin electrophysiol. July 2004;27:983-992.

10 sprenger m. Comparison of manufacturer’s aT/af Detection accuracy across Clinical studies. January 2015. medtronic data on file.

11 Ziegler pD. accuracy of atrial fibrillation Detection in implantable pacemakers. Heart rhythm. 2013;10:s147 [po02-08]

12 medtronic Data on file. QaDoc Dsn026170, Version 2.0, “aT/af Duration performance Comparison.”

13 Kauffman es, israel CW, nair gm, et al. positive predictive value of device-detected atrial high-rate episodes at different rates and durations: a n analysis from asserT. Heart rhythm. august 2012;9(8):1241-1246.

14 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.

15 gillis am, et al. reducing unnecessary right ventricular pacing with the managed ventricular pacing mode in patients with sinus node disease and aV block.paCe 2006; 29:697–705.

16 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.

17 m964378001B azure™ mri surescan™/astra™ mri surescan™ pacing systems mri Technical manual.

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