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References 1 Zhan C, Baine WB, Sedrakyan A, Steiner C. Cardiac device

implantation in the United States from 1997 through 2004: a population-based analysis. J Gen Intern Med. January 2008;23(Suppl 1):13-19.

2 National Cancer Institute April 2009. US estimated complete prevalence (including counts) by age on 1/1/2006. Based on November 2008 SEER data submission; DCCPS, Surveillance Research Program, Statistical Research and Applications Branch.

3 Lawrence RC, Helmick CG, Arnett FC, et al. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. May 1998;41(5):778-799.

4 American Heart Association. Heart Disease and Stroke Statistics – 2010 Update: Learn and Live. Prevalence of stroke by age and sex (NHANES: 2003-2006).

5 http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/docs/fs_stroke.pdf

6 Gunnarsson C, et al. Presented at HRS 2013 (PO04-06). 7 Ramza, et al. Are There Cumulative Effects of Multiple MRI on

MR-conditional Pacemakers? Presented at HRS 2014. 8 Rome, Sarah. Advisa SR MRI SureScan Longevity Calculation.

February 2015. Medtronic Data On File. 9 Demmer, Wade. Advisa SR MRI SureScan EGM Storage

Calculation. February 2015. Medtronic Data On File.10 Adapta/Versa/Sensia Reference Guide.11 Advisa DR MRI™ SureScan A2DR01, ADVISA SR MRI™ SureScan

A3SR01 Clinician Manual.12 Rosenthal LS, Mester S, Rakovec P, et al. Factors influencing

pacemaker generator longevity: results from the complete automatic pacing threshold utilization recorded in the CAPTURE Trial. Pacing Clin Electrophysiol. August 2010;33(8):1020-1030.

13 Stone JE, Crossley GH. Current sensor technology for heart rate modulation by artificial pacing. Cardiac Electrophysiology Review. July 1999;3(1):10-14.

14 Nordlander R, Hedman A, Pehrsson SK. Rate responsive pacing and exercise capacity – a comment. Pacing Clin Electrophysiol. May 1989;12(5):749-751.

15 Purerfellner H, Gillis AM, Holbrook R, Hettrick DA. Accuracy of atrial tachyarrhythmia detection in implantable devices with arrhythmia therapies. [published correction appears in Pacing Clin Electrophysiol. October 2004;27(10):following table of contents]. Pacing Clin Electrophysiol. July 2004;27(7):983-992.

16 Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. December 2006;3(12):1445-1452.

17 Gillis AM, Pürerfellner H, Israel CW, et al. Reduction of unnecessary ventricular pacing due to the Managed Ventricular Pacing (MVP) mode in pacemaker patients: Benefit for both sinus node disease (SND) and AV block (AVB) indications. Heart Rhythm. May 2005;2(5):S40. Abstract AB21-1.

18 Park SM, Lazebnik M, Hunt JJ, et al. A path to safe MRI scanning of cardiac pacemaker patients: A role for computer modeling. WCHD. 2012;AB241.

19 Gimbel JR, et al. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. May 2013;10(5):685-691.

20 Wilkoff BL, Bello D, Taborsky M, et al. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm. January 2011;8(1):65-73.

21 Shenthar J, Milasinovic G, Al Fagih, A, et al. MRI scanning in patients with new and existing CapSureFix Novus 5076 pacemaker leads: randomized trial results. Heart Rhythm. Published online December 30, 2014. http://www.heartrhythmjournal.com/article/S1547-5271(14)01553-7/pdf

22 Data from 2010 MarketScan® Commercial and Medicare databases from Truven Health Analytics, Inc. were used to characterize non-pacemaker and pacemaker cohorts and utilization or radiology services. Cohorts were matched based on age, gender, and co-morbidities.

23 Schwitter J, Kanal E, Schmitt M, et al. Impact of the Advisa MRI pacing system on the diagnostic quality of cardiac MR images and contraction patterns of cardiac muscle during scans: Advisa MRI randomized clinical multicenter study results. Heart Rhythm. June 2013;10(6):864-872.

24 Yokoyama K, Nitatori T, Kanke N, Suzuki S. Efficacy of cardiac MRI in the evaluation of ischemic heart disease. Magn Reson Med Sci. April 2006;5(1):33-40.

25 Andersen HR, Nielsen JC, Thomsen PEB, et al. Long-term follow-up of patients from a randomised trial of atrial versus ventricular pacing for sick-sinus syndrome. Lancet. October 25,1997;350(9086):1210-1216.

26 Skanes AC, Krahn AD, Yee R, et al, for the CTOPP Investigators. Progression to chronic atrial fibrillation after pacing: the Canadian Trial of Physiologic Pacing. J Am Coll Cardiol. July 2001;38(1):167-172.

27 Nielsen J, Kristensen L, Andersen H, et al. A randomized comparison of atrial and dual chamber pacing in 177 consecutive patients with sick sinus syndrome. J Am Coll Cardiol. August 20, 2003;42(4):614-623.

28 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.

29 The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. The Boston Area Anticoagulation Trial for Atrial Fibrillation Investigators (BAATAF). N Engl J Med. November 29, 1990;323(22):1505-1511.

30 Passman RS, Weinberg KM, Freher M, et al. Accuracy of mode switch algorithms for detection of atrial tachyarrhythmias. J Cardiovasc Electrophysiol. July 2004;15(7):773-777.

31 Boriani G, et al. Atrial Antitachycardia Pacing and Managed Ventricular Pacing Reduce the End Point Composed by Death, Cardiovascular Hospitalizations, and Permanent Atrial Fibrillation Compared to Conventional Dual Chamber Pacing in Bradycardia Patients: Results of the MINERVA Randomized Study. AHA Late Breaking Clinical Trial, November 18, 2013.

Advisa MRI™ SureScan® PACING SYSTEMS

www.medtronic.com

Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 Medtronic USA, Inc. Toll-free: 1 (800) 328-2518(24-hour technical support for physicians and medical professionals)

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rt

Think Beyond The hearT

18%

16%

14%

12%

10%

8%

6%

4%

2%

0%30s 40s 50s 60s 70s

Prev

alen

ce in

US

Popu

latio

n

Age by Decade

StrokeProstate CancerOsteoarthritisColorectal Cancer

The Prevalence of Common Comorbidities Increases Rapidly Over Age 652-4

Stroke is a leading cause of death and the leading cause of permanent disability in the United States.4,5

Pacemaker patients are more likely to need an MRI

86% of pacemaker patients are at least 65 years old and have multiple comorbidities for which MRI may be needed.1-4

Now SureScan® patients are getting MRI scans

Stroke patients with a pacemaker are not getting optimal diagnostic imaging

49% of non-pacemaker patients undergo an MRI within 3 days of stroke or TIA diagnostic vs. 0.34% of patients with a traditional pacemaker.6

49%

0.34%

80%

60%

40%

Perc

ent o

f Pat

ient

s

20%

0%MRI CT Ultrasound

Pacemaker

Non-Pacemaker

100%49%

0.34%

80%

60%

40%

Perc

ent o

f Pat

ient

s

20%

0%MRI CT Ultrasound

Pacemaker

Non-Pacemaker

100%

Historically, pacemaker patients are being denied access to MRI6

20% of patients with SureScan devices are estimated to undergo an MRI at 24 months post-implant.7

Pacemaker Cohort* (n = 27,580)% of patients with traditional pacemaker

receiving an MRI annually

Non-Pacemaker Cohort* (n = 27,580)% of patients receiving an MRI annually

MRI0.32%

MRI15%

Post-Approval Study (n = 2,009)% of patients receiving an MRI annually

MRI13%

Top Imaging Diagnostic Procedures for stroke patients within 3 days of stroke or TIA diagnosis

Of those patients receiving a scan, 47% had no previous MRI and/or CT scan prior to implantation of the SureScan pacing system (preliminary results of the SureScan post-approval study).7

* Patient cohorts were matched so both represent a group of patients with the same 1) Gender, 2) Age, 3) Major comorbidities.

0.32% of traditional pacemaker patients get an MRI annually versus 15% of non-pacemaker patients.6

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Months Since Implant0 3 6 9 12 15 18 21 24

Months Since Implant0 3 6 9 12 15 18 21 24

0%

5%

10%

15%

20%

25%

Firs

t MRI

Occ

urre

nce

0%

5%

10%

15%

20%

25%

15.4% 17.5%

20.2%

2.6% 5.7%

8.3% 10.5%

12.8%

MRI Rate Following Implant of Full SureScan SystemPost-Approval Study (n = 2,637)

† Advisa SR MRI is only approved for use with the 5086MRI lead. * The service life projections are based on the following

assumption: VVIR, 100% pacing, 2.5 V, 60 ppm, 0.4 ms, 500 ohms. VVIR only, not AAIR.

** Includes 2 additional minutes of patient-activated episodes viewable only on the CareLink® Network.

Extending the SureScan family to patients indicated for single chamber pacing

Also included in the SureScan family are the Advisa DR MRI and Revo DR MRI SureScan pacemakers.

advisa sr Mri™† surescan WITH 5086MRI

Dual Chamber

MosT advanced PACING TECHNOLOGY Feature Adapta® DR10

ADDR01Advisa DR MRI®11

A2DR01

SureScan Technology Full body MRI access with no position restrictions P

On Screen Cardiac Compass® and Rate Histograms P

Complete Capture Management™ Proven to extend longevity of the device by up to one year12 P P

High Upper Tracking Rates Provide pacing support at higher heart rates for active and younger patients

210 bpm 210 bpm

Upper Sensor Rate 180 bpm 175 bpm Rate Drop Response

May reduce the frequency of syncopal episodes13,14 P P

Programmable Polarity May reduce the likelihood for lead modification post-implant P P

AF Diagnostics AT/AF Detection Accuracy15,16 P P

Atrial Reactive ATP® P

MVP® Reducing unnecessary ventricular pacing has been shown to reduce the risk of AF.17-20 MVP has been shown to reduce unnecessary ventricular pacing.17

P P

EGM Storage/Maximum # of Episodes 48 sec/8 23 min/> 100

Patient-Activated EGM Viewer P Longevity

(DDD, 100% pacing, 2.5 V, 60 ppm, 500 ohms)9.0 years 8.7 years

Single Chamber

Feature Adapta SR10

ADSR01Advisa SR MRI™11

A3SR01

SureScan Technology Full body MRI access with no position restrictions P

On Screen Cardiac Compass and Rate Histograms P Ventricular Capture Management®

Provides confidence in your patients’ safety with automatic threshold measurements and adjustments

P P

Upper Sensor rate 180 bpm 175 bpm

Programmable Polarity May reduce the likelihood for lead modification post-implant P P

EGM Storage/Maximum # of Episodes 48 sec/8 9 min/> 30**

Patient-Activated EGM Viewer P Longevity*

* VVIR, 100% pacing, 2.5 V, 60 ppm, 0.4 ms, 500 ohms 8.7 years 11.7 years

No

CoM

proM

ises in th

erapy

GreaterLongevity*

35%35%

11x11x

EGM Storage**versus Adapta SR9

versus Adapta® SR8

EnRhythm® DR MRI Trial*20

464 SureScan Patients

• Safety and Efficacy• Prospective, Randomized• Published: 2011, Heart Rhythm

Advisa DR MRI® Trial19

263 SureScan Patients

• Safety and Efficacy • Prospective, Randomized

5076 MRI Trial21

266 SureScan Patients

• Safety and Efficacy of 5076 lead in MRI scans• Prospective, Randomized

SureScan post-approval study7

• MRI-related complications and complication rate for 5086MRI lead• Non-randomized, multi-center study regulated by the FDA

2,637 Currently Enrolled

* This study was conducted with the C1-T12 MRI scan exclusion zone in place.

• Industry proprietary computer model evaluated more than 2 million scenarios18

• Over 3,600 patients studied in four prospective clinical studies7,19,20

• 20.2% of SureScan MRI pacemaker patients are estimated to undergo an MRI within 24 months post-implant in the US7

Advisa DR MRI Clinical Trial19

Advisa MRI SureScan system is safe and effective in the MRI environment • Prospective, randomized, controlled, multi-center/263 patients

• Designed to confirm safety, effectiveness, and image quality for MR scans of chest area with no isocenter positioning restrictions

Results – Safety and Effectiveness• No MRI-related complications

• No difference in pacing capture threshold changes between the MRI and control groups

SUPPORTED BY ExTENSIVE evidence AND experience

Suppo

rted by exten

Sive evid

ence A

nd

experien

ce

80%

60%

40%

Perc

ent o

f Sub

ject

s

Change in Atrial Pacing Capture Threshold (V)

20%

0%-0.50

2% 3% 2% 3% 0% 0%5%

13%18%

25%

65% 64%MRI (n = 141)

Control (n = 75)

-0.25 0.25 0.500

Change in Ventricular Pacing Capture Threshold (V)

-0.75

1% 1%1%1% 2% 2% 3%3%0% 0%

15%9%

17% 16%

66%63%

MRI (n = 149)

Control (n = 80)

-0.25-0.50 0.500.25 0.75 1.750

80%

60%

40%

Perc

ent o

f Sub

ject

s

20%

0%

80%

60%

40%

Perc

ent o

f Sub

ject

s

Change in Atrial Pacing Capture Threshold (V)

20%

0%-0.50

2% 3% 2% 3% 0% 0%5%

13%18%

25%

65% 64%MRI (n = 141)

Control (n = 75)

-0.25 0.25 0.500

Change in Ventricular Pacing Capture Threshold (V)

-0.75

1% 1%1%1% 2% 2% 3%3%0% 0%

15%9%

17% 16%

66%63%

MRI (n = 149)

Control (n = 80)

-0.25-0.50 0.500.25 0.75 1.750

80%

60%

40%

Perc

ent o

f Sub

ject

s

20%

0%

No

CoM

proM

ises in th

erapy

FuLL Body Mri accessNo PoSItIoNINg ReStRIctIoNS FoR MR ScANS

Tested and Approved for Cardiac MRISureScan devices do not reduce diagnostic quality of Cardiac MRI (CMR) imaging23

The Importance of Cardiac MRI

• Cardiac MRI (CMR) is emerging as one of the fastest growing new fields of broad MR application24

• CMR can now be used for morphological and functional evaluation of the heart with good reliability and high spatial and temporal resolution24

• Cardiac MRI is employed mainly for assessing ischemic heart disease in a single examination, serving as a true comprehensive cardiac study24

95%98%

LV

Advisa DR MRI patients (n = 150)

Advisa DR MRI Clinical Study – CMR Image Quality Evaluation23Left ventricular (LV) and right ventricular (RV) cine long-axis

RV

The Advisa DR MRI clinical study showed that 95 to 98% of cardiac MRI images are of diagnostic quality.23

40% of all MRIs are performed in the torso area. Now, SureScan patients can easily undergo these MRI scans without any positioning restrictions.22

No

CoM

proM

ises in th

erapy

95%At/AF Detection

Accuracy19,30

• Appropriate initiation of anticoagulants can reduce the risk of AF-related strokes by up to 80%29

• Medtronic pacing devices have less than 5% false positive rates for AF detection.15,30 Therefore, clinicians can feel confident taking clinical action based on device reported AF without the need for intensive review of individual episodes.

23 minutes of high quality EGM storage visible through the CareLink Network. Cardiac Compass report provides AT/AF burden information.

49% of patients with a stroke or TIA diagnosis receive an MRI within 3 days6

Exclusive Atrial Reactive ATP + Atrial intervention + MVP is clinically proven to reduce permanent AF by 61% compared to standard dual chamber pacing31

Mri

Mvp

AtRIAl

aTp

Mvp

Reducing unnecessary ventricular pacing has been shown to reduce the risk of AF25-28

• MVP has been shown to reduce unnecessary ventricular pacing17

RED

UCE

DET

ECT

TREA

T

+

Atrial Reactive ATP + Atrial intervention + MVP = 61% relative reduction in permanent AF31

MINERVA Study

Objective

• To demonstrate benefit of Atrial ATP + Atrial intervention + MVP in delaying AF disease progression compared to standard dual chamber pacing

Study Design

• Randomized, prospective, international study • Bradyarrhythmia patients with no history of permanent AF or

third-degree AV block

Results

Compared to the Control DDDR patients at 2 years, Atrial ATP + Atrial intervention + MVP patients experienced:

• 61% relative reduction in permanent AF31

• 52% reduction in AF-related hospitalizations and ER visits31

cLinicaLLy proven to betteR Detect AND tReAt AF ADVISA DUAL CHAMBER PACEMAKER

0

0.00

0.10

0.20

0.30

Risk

of P

erm

anen

t AF

Observation Period (month)6 12 18 24

Control DDDR Atrial ATP + Atrial Intervention + MVP

Log Rank p-value comparing

Risk of Permanent Atrial Fibrillation31

61%relativereduction

Clin

iCa

lly

Pro

ven

to

bet

ter

Det

ect

an

D t

reat

af

Exclusive – Reactive Atrial ATP* Offers more opportunities to restore and maintain sinus rhythm

• In some patients, AT/AF episodes tend to change in pattern and rate. A patient’s AF may at one point transition back to AT or to atrial flutter, and then change once again into AF.

• Changes in a rhythm’s regularity and/or cycle length present new opportunities for ATP to be successful in terminating the arrhythmia

• Reactive ATP continuously monitors and allows for multiple deliveries of programmed ATP therapies for longer atrial episodes if the arrhythmia shifts in rate or regularity

AF AFAT

Observation Period (month)

Risk of Persistent AF31(episodes longer than 7 days)

0.50

0.40

0.30

0.20

0.10

0.00

0 3 6 9 12 15 18 21 24

Log Rank p-value comparingControl DDDR vs.aATP + Atrial Intervention + MVP (ATP success ≤ 43%)aATP + Atrial Intervention + MVP (ATP success > 43%)

34%28%

15%

In the MINERVA study, increased ATP efficacy is associated with lower risk of persistent AF31

• This points to the second generation Atrial Reactive ATP’s ability to disrupt AT/AF episodes as the likely driver of the results seen in MINERVA

Brief Statement: Advisa DR MRI® and Advisa SR MRI™ SureScan® Pacing Systems

The Advisa DR MRI and Advisa SR MRI SureScan pacing systems are MR Conditional, and as such designed to allow patients to undergo MRI under the specified conditions for use. A complete SureScan pacing system, which consists of an approved combination (see http://www.mrisurescan.com/) MRI SureScan device with SureScan lead(s), is required for use in the MRI environment. Consult the device manuals to ensure all system components are MR Conditional.

Indications: The Advisa DR MRI SureScan Model A2DR01 and Advisa SR MRI SureScan Model A3SR01 IPGs are indicated for use as a system. A complete SureScan pacing system, including an Advisa MRI SureScan IPG and SureScan lead(s), are required for use in the MRI environment.

The Advisa DR MRI and Advisa SR MRI SureScan systems are indicated for the following:• Rate adaptive pacing in patients who may benefit from

increased pacing rates concurrent with increases in activity

• Accepted patient conditions warranting chronic cardiac pacing include:– Symptomatic paroxysmal or permanent second- or

third-degree AV block– Symptomatic bilateral bundle branch block– Symptomatic paroxysmal or transient sinus node

dysfunctions with or without associated AV conduction disorders

– Bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias

The Advisa DR MRI device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include:• Various degrees of AV block to maintain the atrial

contribution to cardiac output• VVI intolerance (for example, pacemaker syndrome) in

the presence of persistent sinus rhythm• Vasovagal syndromes or hypersensitive carotid sinus

syndromes• Antitachycardia pacing (ATP) is indicated for termination

of atrial tachyarrhythmias in bradycardia patients with one or more of the above pacing indications.

Contraindications: The Advisa DR MRI and Advisa SR MRI SureScan systems are contraindicated for:• Concomitant implantation with another bradycardia

device• Concomitant implantation with an implantable

cardioverter defibrillator

There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient’s age and medical condition, however, may dictate the particular pacing system, mode of operation, and implantprocedure used by the physician.• Rate-responsive modes may be contraindicated in those

patients who cannot tolerate pacing rates above the programmed Lower Rate

• Dual chamber sequential pacing is contraindicated in patients with chronic or persistent supraventricular tachycardias, including atrial fibrillation or flutter

• Asynchronous pacing is contraindicated in the presence (or likelihood) of competition between paced and intrinsic rhythms

• Single chamber atrial pacing is contraindicated in patients with an AV conduction disturbance

• ATP therapy is contraindicated in patients with an accessory antegrade pathway

Warnings and Precautions: Changes in patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Use of the device should not change the application of established anticoagulation protocols.

Patients and their implanted systems must be screened to meet the following requirements:• no lead extenders, lead adaptors or abandoned leads• no broken leads or leads with intermittent electrical

contact as confirmed by lead impedance history• a SureScan pacing system that has been implanted for a

minimum of 6 weeks• a SureScan pacing system implanted in the left or right

pectoral region• pace polarity parameters set to Bipolar for

programming MRI SureScan to On• pacing capture thresholds of ≤ 2.0 volts (V) at a pulse

width of 0.4 milliseconds (ms)• a lead impedance value of ≥ 200 ohms (Ω) and ≤ 1500 Ω• no diaphragmatic stimulation at a pacing output of

5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is on

Potential Complications: Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, acceleration of tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis. Potential lead complications include, but are not limited to, valve damage, fibrillation, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation, or exit block. The SureScan system has been designed to minimize potential complications in the MRI environment. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or induced currents on leads resulting in continuous capture, VT/VF, and/or hemodynamic collapse.

See the device manuals before performing an MRI Scan for detailed information regarding the implant procedure, indications, MRI conditions of use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic at 1 (800) 328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

* The rATP studied in the MINERVA trial is available in our Advisa MRI and Revo MRI® dual chamber pacemakers.