EXPERIENCE THE REVEAL LINQ ADVANTAGE · Comparison of AF burden detected by ICM and Holter Reveal LINQ™ Insertable Cardiac Monitoring System . 13 PROVEN ACCURACY PATIENT AND EPISODE-BASED

EXPERIENCE THE REVEAL LINQ™ ADVANTAGE

REVEAL LINQ™ INSERTABLE CARDIAC MONITOR AN OVERVIEW

REVEAL™ ICM PRODUCT EVOLUTION

1998: Reveal

2000: Reveal Plus

2007: Reveal DX

2009: Reveal XT

2011: Fullview

Software

World’s first

implantable loop

recorder

14-month battery

World’s second

implantable loop

recorder

14-month battery

MR-conditional

3-year battery

Added to the

Medtronic CareLink™

Network

MR-conditional

3-year battery

AF detection

algorithm

Cardiac Compass

diagnostics

Improved data

viewing and collection

Improved noise

discrimination

algorithm

Improved AF

detection algorithm

OVER 20 YEARS OF DEVELOPMENT EXPERIENCE IN ICMS

2014: Reveal LINQ ICM World’s smallest insertable cardiac monitor Simplified insertion procedure New AF detection algorithm with increased accuracy Simplified and streamlined reporting and patient management Most studied ICM on the market with 500+ publications1

Reveal LINQ™ Insertable Cardiac Monitoring System 2

REVEAL LINQ SYSTEM ADVANTAGES POWERFUL CARDIAC MONITORING

Indications for use

The Reveal LINQ Insertable Cardiac Monitor (ICM) is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:

• Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

• Patients who experience transient symptoms such as dizziness, palpitation, syncope and chest pain, that may suggest a cardiac arrhythmia

The device has not been tested specifically for pediatric use.


REVEAL LINQ SYSTEM ADVANTAGES POWERFUL CARDIAC MONITORING

ICMs are underutilized

ICMs are recommended by clinical guidelines2,3 ─ yet significantly underutilized

Up to

3 in 4 Patients who met appropriate criteria for ICM implantation did not receive one4


Patient Assistant Insertion Tools NEW app-based Reveal LINQ™ Mobile Manager

Solution Enablers

*Available in select U.S. markets.

CareLink Network & Reports

MyCareLink™ Patient Monitor

Reveal LINQ ICM Wireless Cellular

NEW Monitoring Service Solutions*

REVEAL LINQ SYSTEM ADVANTAGES AN ADVANCED MONITORING SOLUTION


REVEAL LINQ SYSTEM ADVANTAGES REVOLUTIONIZING CARDIAC MONITORING

The smallest, most powerful insertable cardiac monitor

One-third the size of a AAA battery (1.2 cc)

6 Reveal LINQ™ Insertable Cardiac Monitoring System

Up to a 3-year longevity for long-term monitoring5

MR Conditional at 1.5 and 3.0 Tesla

Minimally invasive, simplified insertion procedure6

96.7% of patients very satisfied or satisfied with Reveal LINQ ICM after insertion7

REVEAL LINQ SYSTEM ADVANTAGES SIMPLE INSERTION PROCEDURE

Best location: 45 degrees to sternum over 4th intercostal space, 2 cm from left edge of sternum

97% Of physicians found the insertion tool simple and intuitive.6


Patient Assistant

4 episodes @ 7.5 minutes each

3 episodes @ 10 minutes each

2 episodes @ 15 minutes each

Patient-activated

Patient-activated

Patient-activated

9 min prior

14 min prior 1 min

1 min

1 min 6.5 min prior

REVEAL LINQ SYSTEM ADVANTAGES SMART ECG DATA STORAGE

ECG data storage: 59 minutes total

Patient-activated: up to 30 minutes


REVEAL LINQ SYSTEM ADVANTAGES SMART ECG DATA STORAGE

ECG data storage: 59 minutes total

Automatically detected: 27 minutes

Pause, Brady, Tachy

End of episode

Start of episode

30 sec 27 sec

Automatic detection

AT/AF

2 minutes of longest AF episode stored since last interrogation in addition to the 27 minutes of automatically detected episodes.


10

REVEAL LINQ SYSTEM ADVANTAGES TRANSFORMING CARDIAC MONITORING

Transforming your ability to diagnose and treat even the most difficult-to-detect arrhythmias

PROVEN ACCURACY

CLINICAL RIGOR

ADVANCED MONITORING

Evidence superiority.1,8-11

Real-world impact. 8,12,13

Proven arrhythmia detection. 8,14,15

Informed clinical decisions.

Innovative solutions.

Simplified experience.

Reveal LINQ™ Insertable Cardiac Monitoring System

11

REVEAL LINQ SYSTEM ADVANTAGES PROVEN ARRYTHMIA DETECTION. INFORMED CLINICAL DECISIONS.

Highest published AF detection accuracy on the market, at 99.4%, streamlines data review8

63% fewer false positives than shown in other ICM published data14

As the most clinically-validated ICM, with 50+ detection performance papers, Reveal LINQ is the reliable choice for arrhythmia management15

99.4%

63%

50+

Reveal LINQ is proven to find AF


12

PROVEN ACCURACY DURATION-BASED PERFORMANCE METRICS

Reveal LINQ AF monitoring

Duration-based performance metrics8 98.4% SENSITIVITY

99.5% SPECIFICITY

99.4% ACCURACY

97.2% PPV

99.7% NPV

Comparison of AF burden detected by ICM and Holter


13

PROVEN ACCURACY PATIENT AND EPISODE-BASED PERFORMANCE METRICS

Reveal LINQ AF monitoring

Patient- and episode-based performance metrics8

Patient-based Episode-based


Sensitivity

97.4%

Specificity

97.0%

PPV

92.5%

NPV

99.0%

Accuracy

99.4%

Specificity

97.1%

PPV

90.4%

PROVEN ACCURACY AF FALSE POSITIVE COMPARISON

63% fewer false positives with Reveal LINQ than shown in other ICM published data14

50

%

Confirm-AF16

BioMonitor 2-AF17

Reveal LINQ8

Fal

se P

osi

tiv

e R

ate

*

0%

2

5%

9.6%

26.3%

40.9%


*% of False Positives = (1 –Episode PPV). Episode PPV may vary (gross, patient average).

15

PROVEN ACCURACY AT/AF SUMMARY REPORT

Provides an overview of all atrial arrhythmias detected, including:

% of time in AT/AF

Average time in AT/AF per day

Number of episodes at a given duration

All patient and clinical data are fictitious and for demonstration purposes only.


16

PROVEN ACCURACY REVEAL LINQ ICM CARDIAC COMPASS™ REPORT

All patient and clinical data are fictitious and for demonstration purposes only.

Daily AF Burden

Day/Night HR

Heart Rate Variability

Ventricular Rate During AF

Patient Activity


17

CLINICAL RIGOR EVIDENCE SUPERIORITY. REAL-WORLD IMPACT.

With an evidence portfolio of 500+ published clinical articles and abstracts1

Across Cryptogenic Stroke, Syncope, and Atrial Fibrillation patient populations8-10

Published in multiple premier journals, including Heart Rhythm, The New England Journal of Medicine and JACC 8,9,11

Most Studied ICM

Most Clinically Validated ICM

Only ICM with Premier Clinical Evidence


CLINICAL RIGOR CRYPTOGENIC STROKE

Diagnosis of AF in stroke patient changes treatment protocol

3 million patients in the US have AF18

AF increases the risk of stroke 5×.18

Treatment with Oral Anti-coagulation (OAC)Therapy reduces the likelihood of experiencing stroke by 67%.19

Stroke is the predominant cause of mortality and morbidity in patients with AF.18

61% of patients who had both AF and a stroke did not know they had AF prior to their stroke18


1/3 of Ischemic Strokes are Cryptogenic20

20% Cardioembolic

30% Cryptogenic Stroke

30% Large Vessel

15% Small Vessel

5% Other


Clinical impact of Reveal ICM in stroke Detection of AF allows for treatment with OAC therapy

Landmark Crystal-AF Study, published in the NEJM9

More patients with AF detected at 12 months with Reveal ICM9

Median number of days to AF detection over 12 months9

7×

84

Percent of patients prescribed OAC once AF was detected9

97%

7X



Real-world practice with Reveal LINQ ICM Superiority of Reveal LINQ system to detect AF in Cryptogenic Stroke patients

Real-world practice validates superiority of the Reveal LINQ System to detect AF in cryptogenic stroke (CS) patients12,13

Everyday use of Reveal LINQ confirms findings in landmark CRYSTAL AF study (NEJM, 2014), and emphasizes need for long-term monitoring in CS patients9,12,13

72% of AF patients would be missed if monitoring ends at 30 days12

AF


12

21

CLINICAL RIGOR SYNCOPE

40% of the population will experience syncope21

Cardiac syncope doubles the risk of death

MORTALITY

Cardiac condition doubles the risk of death and increases the 6-month mortality rate by 10%22

MAGNITUDE

3-5% of all ER visits23

1-3% of all hospitalizations23

UNDIAGNOSED

50% of all patients leave the hospital without a diagnosis24

FRUSTRATION

13 different tests during diagnosis period10

Syncope patient visits 3 specialists on average10


22


Limited yield of many diagnostic tests

Diagnostic yield of non implantable diagnostic tests is less than 50%

11%

2%

20%

11%

49%

4%

78%

0%

20%

40%

60%

80%

100%

ECG Holter Monitor External LoopRecorder

EP Study w/oStructural Heart

Disease

EP Study WithStructural Heart

Disease

Neurological (CT,Carotid Doppler)

Reveal ICM

Dia

gn

ost

ic Y

ield

*


25 26

11

27 28

29

10

*Based on mean diagnosis time of 5.1 mos.

23


SYNCOPE GUIDELINES, European Heart Journal 20092 Recommendations for the use of ICM monitoring

Guidelines for the diagnosis and management of syncope (version 2009) The Task Force for the Diagnosis and Management of Syncope of the European Society of Cardiology (ESC)

Developed in collaboration with European Heart Rhythm Association (EHRA),

Heart Failure Association (HFA), and Heart Rhythm Society (HRS)

Monitoring Choice by Frequency of Symptoms3

Frequency of symptoms Suggested ECG monitoring technique

Daily

Every 2-3 days

Every week

Every month

Less than once per month

24 h Holter, in-hospital telemetric monitoring

48-72 h Holter, in-hospital telemetric monitoring

7 days Holter or external loop recorder

14-30 days external loop recorder

Implantable loop recorder

Monitoring Choice by Patient Risk2


24

CLINICAL RIGOR ATRIAL FIBRILLATION

SUSPECTED AF MONITORING Continuous monitoring can reveal AF

Symptoms are not a good indicator for presence of AF30-34

Continuous monitoring with ICMs can identify AF in patients at high risk35, 36

Study Method of Monitoring % Asymptomatic AF

Page et al. 199430 External monitors: 1 day/week (5×)

92.3% of episodes

Strickberger et al. 200531

Implantable Pacemakers 94% of episodes

Quirino et al. 200932 Implantable Pacemakers 81% of episodes

Orlov et al. 200733 Implantable Pacemakers 94.7% of episodes

Verma et al. 201334 Implantable Loop Recorders 79% of episodes

22% of a patient population at high risk was found to have > 6min of AF within 12 months36


25

CLINICAL RIGOR ATRIAL FIBRILLATION

AF MANAGEMENT Optimize decisions pre- and post-ablation

PRE

Document Baseline AF burden.

Provide objective data for follow-up comparisons.

Data to optimize pre/post management + re-ablation

Case Planning

PVI when Paroxysmal AF is documented?

PVI + additional lines if substrate ablation is needed

Work Flow Planning

Minimize days with difficult back-to-back cases.

Triage patients on your waiting list.

POST

Monitor patients for up to 3 years.

Optimize medical therapy.

Discontinue OAC?

Re-ablate to disrupt substrate conduction with additional lines.

REVEAL ICM

Reliably identifies AF and confirms the absence of AF.37,38

Features proven AF detection algorithm and published evidence that provides information to make informed decisions.

Proven AF algorithm accurately detects AF 99.4% of the time.8


26

ADVANCED MONITORING INNOVATIVE SOLUTIONS. SIMPLIFIED EXPERIENCE.

STREAMLINED INSERTION WORK FLOW

ACTIONABLE REPORTS SIMPLIFIED PATIENT MANAGEMENT

Supported by an enhanced Medtronic CareLink Network

Industry’s highest diagnostic yields, with actionable reports10,39-41

Simple, minimally invasive outpatient insertion procedure

New app-based device management with the Reveal LINQ Mobile Manager

Resources to support clinic efficiency and data review

New Medtronic Academy Learning Plan

New Patient Education Resources

New Reveal LINQSM

Monitoring Service*

*Available in select U.S. markets.


27

ADVANCED MONITORING NEW REVEAL LINQ MOBILE MANAGER

Simplify device management with the NEW Reveal LINQ Mobile Manager, an innovative app-based programming system

IT’S EASY TO GET STARTED

The Reveal LINQ Mobile Manager can only be used with the Reveal LINQ ICM and the Medtronic patient connector, available from Medtronic.

SUPPORTED TABLET

Visit LINQMobileManager.com

for the most up-to-date list of

supported tablets

WI-FI OR CELLULAR CONNECTION

MEDTRONIC PATIENT CONNECTOR

DOWNLOAD APP ON SUPPORTED TABLET


28

ADVANCED MONITORING CLINICALLY ACTIONABLE REPORTS

Easy-to-use, clinically actionable reports4 The information you need when you need it, supported by an enhanced CareLink Network

Comprehensive

Get the full picture with diagnostic trends on simplified reports.

Customizable

Optional CareAlert™ notifications with auto-generated reports

95%

of physicians found the Reveal LINQ reports easy to use and clinically actionable 6

96.7%

of patients say it is very easy to use the MyCareLink Patient Monitor to transmit data to the CareLink Network6


The Medtronic MyCareLink Patient Monitor and the Medtronic CareLink Network are indicated for use in the transfer of patient data from Medtronic implantable cardiac devices. These products are not a substitute for appropriate medical attention in the event of an emergency. Data availability and alert notifications are subject to Internet connectivity and access, and service availability. The MyCareLink Patient Monitor must be on and in range of the device. Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care.

29

ADVANCED MONITORING CLINICALLY ACTIONABLE REPORTS

Easy-to-use, clinically actionable reports6 The information you need when you need it

Event Report Data may help in timely management of patients.

Completely OPTIONAL Event Reports create work for your clinics. Reserve only for most critical information.

Summary Report Data may help in routine management of patients.

Full Report Manual transmission from patient when you need to know more.


30

ADVANCED MONITORING NEW CLINICIAN LEARNING PLAN

New clinician learning plan on Medtronic Academy Supports streamlined Reveal LINQ patient management

Tailored to meet your needs for easier data and patient management. Integrates best practices from 100+ clinicians nationwide.

Master Use of Reports.

Optimize Alert and Data Collection.

Standardize Work Flows.

Maximize Patient Engagement.

*Provider approved by the California Board of Registered Nursing. Provider Number 13145 , for 1 contact hour per course.

Course completion provides up to 6 CEU hours.*


Access learning plan at: MedtronicAcademy.com/LINQMonitoring

31

ADVANCED MONITORING NEW PATIENT EDUCATION RESOURCES

New patient education system Helps ensure patients get the right information at the right time

We revamped the materials we offer to educate patients, in order to make the flow of information more helpful and clear.


32

ADVANCED MONITORING NEW REVEAL LINQ MONITORING SERVICE

The Reveal LINQ Monitoring Service* A virtual extension of your clinical team, helping you streamline patient management and cardiac data review.


Optimize Your Time Data is

transmitted and then analyzed by

certified technicians at the

Medtronic Monitoring

Center.

Only the most clinically-relevant,

actionable information is

sent to the clinician.

Extra support to feel assured patients are transmitting

regular automatic and manual

transmissions as needed.

*Available in select markets. Connect with your Diagnostics Representative to learn more about the service.

33

ADVANCED MONITORING SYNCOPE PATIENT IMPACT

Debbie’s story Reveal ICM used to discover a rare form of AT

After Debbie fainted the first time, she didn't think much about it. As a cardiac nurse, she knew there were many reasons people faint. But the fainting continued, and within a couple of months she was passing out three times a day. Her cardiologist decided to give Debbie a Medtronic Reveal Insertable Cardiac Monitor (ICM).

Based on the information from the Reveal ICM, her doctors determined Debbie had a rare, aggressive form of atrial tachycardia (AT) that was very resistant to treatment. She tried new medications. Debbie’s doctors also relied on the Reveal ICM to monitor how her heart responds to the therapy.

With her fainting under better control, Debbie got back to practicing ballet.

She encourages people who experience fainting episodes to make a doctor appointment right away.

Photo shown is not actual patient. This story reflects one person’s experience. Not every person will receive the same results.


34

ADVANCED MONITORING CRYPTOGENIC STROKE PATIENT IMPACT

Scott’s story Reveal ICM used to discover AF in 22-year-old stroke patient

On his way to a soccer game, 22-year-old Scott suddenly began wobbling. His head started throbbing. What he thought was dehydration turned out to be much worse. The college student had suffered a stroke. Surgeons removed a blood clot in his brain, but a looming question remained: What caused the stroke in this seemingly healthy young man?

Scott’s doctors suspected it was the result of atrial fibrillation (AF). So Scott’s doctors turned to the Reveal LINQ ICM, which, within a few months, confirmed he had AF.

The diagnosis not only gave Scott’s doctors the information they needed to prescribe stroke-preventive blood thinners; it gave Scott the peace of mind to live life fully again.

Actual patient photo. This story reflects one person’s experience. Not every person will receive the same results.

FPO


35

ADVANCED MONITORING ATRIAL FIBRILLATION PATIENT IMPACT

Debbie’s story Reveal ICM finds AF and Guides EP Treatment Plan

When Debbie started experiencing an uncomfortable heart fluttering, she tried to ignore it. When the episodes became more frequent, she could no longer deny something was wrong. That’s when she made an appointment with a cardiologist.

Debbie’s doctor suggested an insertable cardiac monitor to determine the cause of her episodes. The Reveal ICM discovered that the upper chambers of Debbie’s heart were beating very fast and irregularly.

She was referred to an EP, who used the Reveal ICM data to guide the development of a treatment plan.

Eventually, Debbie regained her old energy and enthusiasm. “I was so excited that it captured an abnormal heart rhythm. It wasn’t in my head after all,” Debbie said.

Actual patient photo. This story reflects one person’s experience. Not every person will receive the same results.


36

ECONOMIC VALUE ICM OVERVIEW

Reduce healthcare utilization through prevention of a second stroke42

Effectively diagnose cardiac arrhythmias in Syncope patients, leading to treatment42

Positive procedural and downstream economics with flexibility of procedure location42

Cryptogenic Stroke

Syncope

Hospital Economics


37

ECONOMIC VALUE CRYPTOGENIC STROKE

7×

67%

$64K+

MORE AF DETECTED at 12 months with Reveal™ ICM in cryptogenic stroke patients9

OAC therapy SIGNIFICANTLY REDUCES the risk of stroke19

ANNUAL COST of stroke-related care is $64,62943


38

ECONOMIC VALUE SYNCOPE

Clinical impact of Reveal ICM in syncope patients

13 Median number of inconclusive tests before ICM was implanted10

78% Patients that receive a diagnosis following a syncopal event with Reveal™ ICM 10

75% of Reveal-guided diagnoses were found to be cardiac related10

25% Reveal ICM patients that receive device therapy within 36 months44


Accurately Diagnose Effectively Treat

39

ECONOMIC VALUE REVEAL LINQ ICM AND THE CARE CONTINUUM

Long-term benefits of Reveal LINQ ICM Accurate diagnosis and defined care continuum

NO ICM IMPLANTED ✕ Care continuum is variable or unknown

✕ Further diagnostic testing, with mixed results

✕ Increased costs and inefficient use of resources

✕ Potential loss of patient to follow-up

✕ A ‘revolving door’ experience for patients

ICM IMPLANTED

Accurate diagnosis of cardiac arrhythmia

Timely and informed treatment decisions

Potential long-term patient care within hospital system

Broad benefits from remote monitoring with MyCareLink™ Patient Monitor

Identify indicated patients with treatment needs

vs.


PATIENT CARE CONTINUUM

40

ECONOMIC VALUE REVEAL LINQ ICM AND PROCEDURAL EFFICIENCIES

Opportunity for procedural efficiencies with Reveal LINQ ICM

On average, savings ranged from

$0 – $681 per implant by moving procedure location45

Cath Lab vs. Procedure Room Costs

Reduced overhead and less expensive equipment outside of the cath lab45

Patient Recovery Location

Choice of implant location may require alternate patient recovery location45

Staffing Requirements

Location of procedure may allow for flexibility in required staff45


41

REFERENCES


1. Medtronic Reveal Publications. Medtronic data on file. 2016. 2. Task Force for the Diagnosis and Management of Syncope, European Society of Cardiology (ESC), European Heart Rhythm Association (EHRA), et al. Guidelines

for the diagnosis and management of syncope (version 2009). Eur Heart J. November 2009;30(21):2631-2671. 3. The Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC), et al. 2013 ESC Guidelines on cardiac pacing and

cardiac resynchronization therapy. Eur Heart J. Aug. 2013; 34(29):2281–2329. 4. Vitale E, Ungar A, Maggi R, et al. Discrepancy between clinical practice and standardized indications for an implantable loop recorder in patients with unexplained

syncope. Europace. Oct. 2010; 12(10):1475-1479. 5. Reference the Reveal LINQ ICM Clinician Manual for usage parameters. 6. Reveal LINQ Usability Study. Medtronic data on file. 2013. 7. Pürerfellner H, Prashanthan S, Pokushalov E, et al. Miniaturized Reveal LINQ insertable cardiac monitoring system: First-in-human experience. Heart Rhythm.

June 2015;12(6):1113-1119. 8. Sanders P, Pürerfellner H, Pokushalov E, et al. Performance of a New Atrial Fibrillation Detection Algorithm in a Miniaturized ICM: Results from the Reveal LINQ

Usability Study. Heart Rhythm. July 2016;13(7):1425-1430. 9. Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. June 26, 2014;370(26):2478-2486. 10. Edvardsson N, Frykman V, van Mechelin R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the

PICTURE registry. Europace. February 2011;13(2):262-269. 11. Krahn AD, Klein GJ, Yee R, Hoch JS, Skanes AC. Cost implications of testing strategy in patients with syncope: randomized assessment of syncope trial. J Am

Coll Cardiol. August 6, 2003;42(3):495-501. 12. Rogers J, Nichols A, Richards M, et al. S42.003 — Incidence of Atrial Fibrillation within One Year of Cryptogenic Stroke among a Large, Real-World Population

with Insertable Cardiac Monitors [abstract]. Presented at the 68th Annual Meeting of the American Academy of Neurology. April 2016. Available at: http://www.abstractsonline.com/pp8/#!/4046/presentation/8072. Accessed April 11, 2016.

13. Ziegler PD, Rogers JD, Ferreira SW, et al. Real-World Experience with Insertable Cardiac Monitors to Find Atrial Fibrillation in Cryptogenic Stroke. Cerebrovasc Dis. Aug. 28, 2015;40(3-4):175-181.

14. False Positive Rate Comparison. Medtronic data on file. 2016. 15. Medtronic Reveal AF Publications. Medtronic data on file. 2016. 16. DEtermining Accuracy and TrEnding CharacTerization of AF. DETECT AF Study Overview on ClinicalTrials.gov. Available at:

https://clinicaltrials.gov/ct2/show/NCT01673256. Accessed July 28, 2016. 17. Biotronik BioMonitor 2 Clinical Manual. 2016. 18. Frankel D, Parker S, Rosenfeld L, et al. HRS/NSA 2014 survey of atrial fibrillation and stroke: Gaps in knowledge and perspective, opportunities for improvement.

Heart Rhythm. August 2015; 12(8):e105-e113. 19. Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. August 1991;84(2):527-539. 20. Adams H, Bendixen B, Kappelle LJ, et al. Classification of Subtype of Acute Ischemic Stroke: Definitions for Use in a Multicenter Clinical Trial. Stroke. Jan. 1993;

24(1):35-41. 21. Kenny RA., et al. Futura;2003:23-27. 22. Soteriades ES, Evans JC, Larson MG, et al. Incidence and prognosis of syncope. N Engl J Med. September 19, 2002; 347(12):878-885. 23. Blanc J-J., L’Her C, Garo B, et al. Prospective evaluation and outcome of patients admitted for syncope over a 1 year period. Eur Heart J. May 2002;23(10):815-

820. 24. Mendu M, McAvay G, Lampert R, et al. Yield of Diagnostic Tests in Evaluating Syncopal Episodes in Older Patients. Arch Intern Med. July 27, 2009;169(14):1299-

1305. 25. Atkins D, Hanusa B, Sefcik T, et al. Syncope and orthostatic hypotension. Am J. Med. 1991;91,179-185.

https://clinicaltrials.gov/ct2/show/NCT01673256

42

REFERENCES


26. Krahn, AD, Klein, GJ, Yee, R. Recurrent syncope: experience with an implantable loop recorder. Cardiol Clin. 1997;15:313–326. 27. Linzer, M., et al. Diagnosing Syncope. Ann Intern Med. 1997;126:989-996. 28. Kapoor, WN. Evaluation and outcome of patients with syncope. Medicine. 1990;69(3):160-175. 29. Kapoor, WN. Evaluation and Management of the Patient With Syncope. JAMA. 1992;11:268 (18):2553-2560. 30. Page R, Wilkinson W, Clair W, et al. Asymptomatic Arrhythmias in Patients With Symptomatic Paroxysmal Atrial Fibrillation and Paroxysmal Supraventricular

Tachycardia. Circulation. Jan. 1994; 89(1):224-227. 31. Strickberger A, Ip J, Saksensa S, et al. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. Feb. 2005; 2(2):125-131. 32. Quirino G, Giammaria M, Corbucci G, et al. Diagnosis of Paroxysmal Atrial Fibrillation in Patients with Implanted Pacemakers: Relationship to Symptoms and Other

Variables. PACE. Jan. 2009; 32:91-98. 33. Orlov M, Ghali J, Araghi-Niknam M, et al. Asymptomatic Atrial Fibrillation in Pacemaker Recipients: Incidence, Progression, and Determinants Based on the Atrial

High Rate Trial. PACE. March 2007; 30:404-411. 34. Verma A, Champagne J, Sapp J, et al . Discerning the Incidence of Symptomatic and Asymptomatic Episodes of Atrial Fibrillation Before and After Catheter Ablation

(DISCERN AF). JAMA Int Med. Jan. 28, 2013;173(2):149-156. 35. Frontera A, Carpenter A, Ahmed N, et al, Demographic and Clinical Characteristics to Predict Paroxysmal Atrial Fibrillations: Insights from an Implantable Loop

Recorder Population. PACE. Oct. 2015; 38(10):1217-1222. 36. Nasir J, Marler A, Pomeroy W, et al. AB07-02 predicting atrial fibrillation for flutter (predate-AF) Study: interim Analysis. Presented at the 37th Annual Meeting of the

Heart Rhythm Society. May 2016. Available at: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0ahUKEwjj8pzvoorNAhUeGlIKHbaAD3wQFggeMAA&url=http%3A%2F%2Fwww.hrssessions.org%2FMedia%2FScientific-Sessions-File-Uploads%2FDocuments%2FHeart-Rhythm-2016%2FFinal-Program-PDF-Thursday&usg=AFQjCNEPtsu-9ylUJ6tRg2jwsty0KHCB4A&bvm=bv.123664746,d.aXo. Accessed June 2, 2016.

37. Hindricks G, Pokushalov E, Urban L, et al. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation – results of the XPECT Trial. Circ Arrhythm Electrophysiol. April 2010;3(2):144-147.

38. Pürerfellner H, Pokushalov E, Sarkar S, et al. P-wave evidence as a method for improving algorithm to detect atrial fibrillation in insertable cardiac monitors. Heart Rhythm. Sept. 2014; 11(9):1575-1583.

39. Krahn AD, Klein GJ, Yee R, Norris C. Final Results From a Pilot Study With an Implantable Loop Recorder to Determine the Etiology of Syncope in Patients with Negative Noninvasive and Invasive Testing. Am J Cardiol. July 1, 1998;82(1):117-119.

40. Krahn AD, Klein GJ, Yee R, Takle-Newhouse T, Norris C. Use of an Extended Monitoring Strategy in Patients with Problematic Syncope. Circulation. January 26, 1999;99(3):406-410.

41. Crossley GH, Boyle A, Vitense H, et al. 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. March 8, 2011;57(10):1181-1189.

42. Reveal LINQ Economic Value Model. Medtronic data on file. 2015. 43. Harrington A, Armstrong E, Nolan P, Malone D. Cost-Effectiveness of Apixaban, Dabigatran, Rivaroxaban, and Warfarin for Stroke Prevention in Atrial Fibrillation.

Stroke. June 2013;44:1676-1681. 44. Medtronic Reveal LINQ Pull Through. Medtronic data on file. 2016. 45. Kanters T, Wolff C, Boyson D, et al. Cost comparison of two implantable cardiac monitors in two different settings: Reveal XT in a catheterization laboratory vs.

Reveal LINQ in a procedure room. Europace. Aug. 19, 2015.

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0ahUKEwjj8pzvoorNAhUeGlIKHbaAD3wQFggeMAA&url=http://www.hrssessions.org/Media/Scientific-Sessions-File-Uploads/Documents/Heart-Rhythm-2016/Final-Program-PDF-Thursday&usg=AFQjCNEPtsu-9ylUJ6tRg2jwsty0KHCB4A&bvm=bv.123664746,d.aXo






















BRIEF STATEMENT MEDTRONIC MYCARELINK™ PATIENT MONITOR, CARELINK™ NETWORK, CARELINK™ MOBILE APPLICATION, REVEAL LINQ™ INSERTABLE CARDIAC MONITOR, PATIENT ASSISTANT, AND REVEAL LINQ™ MOBILE MANAGER The Medtronic MyCareLink Patient Monitor and the Medtronic CareLink Network are indicated for use in the transfer of patient data from Medtronic implantable cardiac devices. These products are not a substitute for appropriate medical attention in the event of an emergency. Data availability and alert notifications are subject to Internet connectivity and access, and service availability. The MyCareLink Patient Monitor must be on and in range of the device. Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care.

Brief Statement Reveal LINQ™ Insertable Cardiac Monitor, Reveal LINQ™ Mobile Manager System and Patient Assistant Indications: The Reveal LINQ Insertable Cardiac Monitor (ICM) is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases: • Patients with clinical syndromes or situations at increased risk

of cardiac arrhythmias • Patients who experience transient symptoms such as dizziness,

palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia

The device has not been tested specifically for pediatric use.

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Reveal LINQ Mobile Manager System The Reveal LINQ Mobile Manager app is intended for programming and interrogating the Reveal LINQ ICM LNQ11. The Medtronic 24965 patient connector is a portable electronic device using low frequency inductive telemetry to communicate with the Reveal LINQ ICM. The patient connector uses Bluetooth™* technology to transmit implantable heart device data to the Reveal LINQ Mobile Manager app for further processing. The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment. Patient Assistant The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management feature in the Reveal Insertable Cardiac Monitor to initiate recording of cardiac event data in the implanted device memory.


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Contraindications: There are no known contraindications for the implant of the Reveal LINQ ICM or for the Reveal LINQ Mobile Manager system. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. Warnings/Precautions Reveal LINQ Insertable Cardiac Monitor Patients with the Reveal LINQ ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound, and radio frequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ MRI Technical Manual. Reveal LINQ Mobile Manager System Before inserting the Reveal LINQ ICM, verify that the patient connector and mobile device are fully charged. The patient connector and mobile device may run out of power during the insertion procedure if they are not fully charged. You will not be able to program or interrogate the patient’s Reveal LINQ ICM until the patient connector and the mobile device have power.

BRIEF STATEMENT MEDTRONIC MYCARELINK™ PATIENT MONITOR, CARELINK™ NETWORK, CARELINK™ MOBILE APPLICATION, REVEAL LINQ™ INSERTABLE CARDIAC MONITOR, PATIENT ASSISTANT, AND REVEAL LINQ™ MOBILE MANAGER, CONT’D.

Only use the patient connector to communicate with the intended implanted device. Do not use the patient connector to communicate with other implanted devices. Using the patient connector to communicate with other implanted devices can interfere with those devices, potentially affecting the other implanted device’s functionality or therapy delivery. Use of wireless devices — The patient connector incorporates radio frequency (RF) communications components which may affect other devices and equipment in the medical environment. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. RF interference may affect device performance. Electromagnetic Compliance (EMC) testing shows that the patient connector provides reasonable protection against harmful interference and provides EMC immunity in a typical medical installation. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. However, there is no guarantee that interference will not occur in a particular installation. If the patient connector does cause harmful interference to other devices or is negatively impacted by other devices, correct the interference by one or more of the following measures: Reorient or relocate the patient connector and other devices; increase the separation between the patient connector and other devices by at least two meters (approximately 6 feet); and/or turn off any interfering equipment.


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Radio frequency (RF) interference — Portable and mobile RF communications equipment can interfere with the operation of the patient connector. There is no guarantee that it will not receive interference or that any particular transmission from this system will be free from interference. To avoid interference, do not use the patient connector and mobile device within 2 m (6 feet) of other wireless communications equipment. Using the patient connector near these devices could interfere with communication between the Reveal LINQ ICM and the patient connector. Security — Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. Bluetooth communication in the patient connector is encrypted for security. Medtronic inductive telemetry uses short-range communication to protect patient information. If the patient connector should fail, there is no risk of patient harm. Environmental precautions — To ensure safe and effective operation, use the device with care to avoid damage to the patient connector from environmental factors that may impair its function. Care is exercised in design and manufacturing to minimize damage to devices under normal use. However, electronic devices are susceptible to many environmental stresses. Specifically, the patient connector may be affected by electrostatic discharge (ESD). In an environment likely to cause ESD, such as a carpeted floor, discharge any charge collected on your body before touching the device.

Patient Assistant Operation of the Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device. Potential Complications: Potential complications of the Reveal LINQ device include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin. Medtronic MyCareLink™ Patient Monitor, Medtronic CareLink™ Network and CareLink™ Mobile Application Intended Use: The Medtronic MyCareLink Patient Monitor and CareLink Network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. The CareLink Mobile Application is intended to provide current CareLink Network customers access to CareLink Network data via a mobile device for their convenience. The CareLink Mobile Application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink Network availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area.


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Mobile device access to the Internet is required and subject to coverage availability. Standard text message rates apply. Contraindications: There are no known contraindications. Warnings and Precautions: The MyCareLink Patient Monitor must only be used for interrogating compatible Medtronic implantable devices. See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/ adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.


http://www.medtronic.com/

http://www.medtronic.com/

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Toll-free: 1.800.328.2518 (24-hour technical support for physicians and medical professionals)

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