Reveal LINQ™

Insertable Cardiac Monitoring System

ESTABLISHING NEW STRATEGIES IN AF DETECTION

Make the LINQ between atrial fibrillation and stroke for patients at high risk.

increase in ischemic stroke risk for AF patients.2

is the first symptom for ~20% of patients who have an AF-related stroke.3

more likely for AF-related ischemic stroke to be fatal as non-AF stroke.3

of AF episodes may be asymptomatic.5

5-FOLD

STROKE

2X

~90%

67%

1/5th

AF DETECTION AND TREATMENT MATTERS

Short-term and intermittent cardiac monitoring may miss many patients with paroxysmal AF6-8

AF + STROKE A GLOBAL HEALTH CHALLENGE

DIFFICULTIES IN AF DETECTION

decrease in AF patient stroke risk with oral anticoagulants.4

of patient symptoms thought to be AF were actually due to AF.5

Symptoms are not a reliable indicator of AF.5

n Short-term monitoring via 24-hour Holter has low sensitivity and negative predictive value for AF detection.6

n Intermittent and symptom-based monitoring has a significantly lower sensitivity and negative predictive value for AF detection compared with continuous monitoring.7

Longer, continuous monitoring periods result in higher AF detection.8

1 IN 4 OF ALL STROKES ARE CAUSED BY AF2

15 MILLION PEOPLE WORLDWIDE EXPERIENCE A STROKE EACH YEAR1

■ Prospective, global, multicenter study■ 446 patients enrolled, 385 patients received a Reveal™ ICM and were

included in the analysis cohort■ Patients were followed for an average of 22.5 months + 7.7 months

A CHADS2 score of ≥ 3 or CHADS2 = 2 and at least 1 of the following:

■ Coronary artery disease■ Renal impairment (GFR 30-60 ml/min)■ Sleep apnea ■ Chronic obstructive pulmonary disease

No AF found after 24 hours of cardiac monitoring.

Primary Determine the incidence rate of AF lasting ≥ 6 minutes in patients who are at high risk of having AF and stroke.

Secondary ■ Identify predictors of AF onset■ Characterize the timing and nature of clinical actions relative

to detection of AF

STUDY DESIGN

PATIENT INCLUSION CRITERIA

END POINTS

REVEAL AF STUDY ARE YOU MONITORING HIGH-RISK PATIENTS LONG ENOUGH?DETECTION RATE OF PATIENTS WITH AF OF ≥ 6 MINUTES IN DURATION9

AF detection rate in high-risk patients at 30 months.9

was the median time to AF detection in high-risk patients.9

of patients with AF would have been missed if only monitored for 30 days.9

40% 123 Days 84.5%

0

5

10

15

20

25

30

35

40

45

0 6 12 18 24 30

385 290 247 208 116 30Subjects at Risk

Number of Months Post-Insertion

20.4%

27.1%

33.6%

AF

Det

ecti

on

Rate

(%)

AF detection rateat 30 days

6.2%

AF detection rateat 18 months

29.3%

AF detection rateat 30 months

40.0%

Incidence of AF in patients at high risk for AF and stroke

Visit medtronic.com/RevealAF for complete study information.

The Reveal AF study may have important implications for prophylactic AF screening and treatment in high-risk patients.9

of patients were prescribed oral anticoagulants during follow-up.9

of patients were prescribed rhythm-control medication during follow-up.9

56.3% 14.8%

REVEAL AF STUDY SECONDARY END POINTS

DETECT AF IN HIGH-RISK PATIENTS WITH THE REVEAL LINQ™ ICM SYSTEM

99.7%

Highest published AF detection accuracy on the market at 99.7% streamlines data review10

Actual size

Patient AssistantOne-button symptom marking with the ability to store multiple patient-activated episodes.

4 episodes @ 7.5 minutes each

3 episodes @ 10 minutes each

2 episodes @ 15 minutes each

14 min prior

9 min prior

6.5 min prior

1 min

1 min

1 min

Patient-activated

Patient-activated

Patient-activated

AN ADVANCED MONITORING SOLUTION

MyCareLink™

Patient Monitor

Cellular

CareLink™ Network and Reports

Reveal LINQ ICM

Wireless

New strategies for patients at high risk for AF and stroke

INFORM YOUR CLINICAL DECISIONS

0

5

10

15

20

25

30

35

40

45

50

55

60

0 6 12 18 24 30

CHADS 4: 104CHADS 3: 129CHADS 2: 152

8192

117

6976

102

605989

333944

119

10

Subjects at Risk

Number of Months Post-Insertion

≥ CHADS 4CHADS 3CHADS 2

24.7%

31.7%

32.7%

AF

Det

ecti

on R

ate

(%)

AF incidence by CHADS2 subgroup9

AF detected through Reveal ICM was found to be actionable by physicians.9

There was no significant difference in detection rates between patients with CHADS2 2, 3, and 4 or more.9

UNMATCHED ACCURACY

DRIVING ACCURACY EVOLUTION Dedicated to advancing accuracy with every device generation.

INDUSTRY-LEADING TRURHYTHM DETECTION Our newest detection algorithms streamline episode review without sacrificing sensitivity.

Self-learning NEW AF algorithm learns and adapts to patients with sinus arrhythmia. AF

Reveal™ XT

Industry’s first AF detection algorithm

Reveal™ XT

Reveal LINQ™

TruRhythm™ Detection

AF

AF

PAUSE

NEW Pause algorithm with diminishing R-wave analysis

NEW AF algorithm with increased accuracy

AF

AF&BRADY

PAUSE

2009 2011 2014 2017

NEW AF algorithm and improved noise discrimination

NEW algorithms with

§ Smart filtering § Smart-learning

intelligence

Advanced AF detection* Reveal LINQ ICM10

Confirm™ ICM11

SUPERIOR ACCURACY IN AF DETECTION Demonstrating superior atrial fibrillation detection accuracy through our performance results.

Streamlined Episode Review

39.3%

26.3%

9.6%

4.7%

AF

Fals

e Po

siti

ve %

†

Confirm-AF11

BioMonitor 2-AF12

Reveal LINQ13

Reveal LINQ with TruRhythm Detection10

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

AF BURDENSensitivity 98.9% 83.9%

PPV 99.0% 97.3%

AF EPISODESensitivity 99.7% 94.0%

PPV 95.3% 59.1%

8X more false positives shown by other ICM.10,11

*In known AF patients.

NEW self-learning threshold rejects false AF in patients with history of P waves.

References1 World Heart Federation statistics. http://www.world-heart-federation.org/cardiovascular-health/stroke/.

2 Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart Disease and Stroke Statistics — 2017 Update. A Report From the American Heart Association. Circulation. March 7, 2017;135(10):e146-e603.

3 Lin HJ, Kelly-Hayes M, Beiser AS, et al. Stroke severity in atrial fibrillation: The Framingham Study. Stroke. October 1996;27(10):1760-1764.

4 Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. August 1991;84(2):527-539.

5 Strickberger, SA, Ip J, Saksena S, et al. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. February 2005;2(2):125-131.

6 Hanke T, Charitos EI, Stierle U, et al. Twenty-four-hour holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months experience with a novel permanently implantable heart rhythw September 15, 2009;120(11 Suppl):S177-184.

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

8 Jabaudon D, Sztajzel J, Sievert K, Landis T, Sztajzel R. Usefulness of ambulatory 7-day ECG monitoring for the detection of atrial fibrillation and flutter after acute stroke and transient ischemic attack. Stroke. July 2004;35(7):1647-1651.

9 Reiffel JA, Verma A, Kowey PR, et al. High Incidence of Previously Unknown (“Silent”) Atrial Fibrillation in Patients at High Risk for Atrial Fibrillation and Stroke: Primary Results from the REVEAL AF Study. Abstract presented at Heart Rhythm Society Annual Scientific Sessions. 2017.

10 TruRhythm Detection Algorithms. Medtronic data on file. 2017.

11 Nölker G, Mayer J, Boldt LH, et al. Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. J Cardiovasc Electrophysiol. December 2016;27(12):1403-1410.

12 Biotronik BioMonitor 2 Clinical Manual. 2016.

13 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.

Brief Statement

Indications

Reveal LINQ™ LNQ11 Insertable Cardiac Monitor and Patient AssistantThe Reveal LINQ insertable cardiac monitor 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

This device has not specifically been tested for pediatric use.

Patient AssistantThe 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.

ContraindicationsThere are no known contraindications for the implant of the Reveal LINQ insertable cardiac monitor. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.

Warnings/PrecautionsReveal LINQ LNQ11 Insertable Cardiac MonitorPatients with the Reveal LINQ insertable cardiac monitor should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound, and radiofrequency 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.

Patient AssistantOperation of the Patient Assistant near sources of electromagnetic interfer-ence, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device.

Potential ComplicationsPotential complications 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. 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 manual 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 medtronic.com.

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

Indications, Safety, and WarningsIf you are located in the United States, please refer to the brief statement below to review applicable indications, safety, and warning information. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 763-514-4000 and/or consult the Medtronic website at medtronic.com.

If you are located outside the United States, see the device manual for detailed information regarding 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 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.

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.

www.medtronic.com/manuals

Medtronic and the Medtronic logo are trademarks of Medtronic. ™Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. Minneapolis, MN. All Rights Reserved.

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Toll-free in USA: 800.633.8766Worldwide: +1.763.514.4000

AF detection rate at 30 months.9

40% 123 daysof patients with AF would have been missed if only monitored for 30 days.9

84.5%

REVEAL AF STUDY Demonstrating the need for long-term, continuous cardiac monitoring for patients at high risk for AF and stroke.9

medtronic.com/RevealAF

was the median time to AF detection in high-risk patients.9

~90%

of AF episodes may beasymptomatic.5

AF is often paroxysmal and difficult to detect with traditional monitoring

modalities.5-8

STROKEis the first symptom for ~20% of patients who have an AF-related stroke.3