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EXPERIENCE THE REVEAL LINQ ADVANTAGE Reveal LINQ TM Insertable Cardiac Monitor with TruRhythm TM Detection The world’s smallest, most accurate ICM

EXPERIENCE THE REVEAL LINQ ADVANTAGE...Exclusive solutions that offer new freedom to focus on patients Actionable data to diagnose and treat ... Diener HC, Passman RS, et al. Cryptogenic

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Page 1: EXPERIENCE THE REVEAL LINQ ADVANTAGE...Exclusive solutions that offer new freedom to focus on patients Actionable data to diagnose and treat ... Diener HC, Passman RS, et al. Cryptogenic

EXPERIENCETHE REVEAL LINQ™

ADVANTAGEReveal LINQTM

Insertable Cardiac Monitorwith TruRhythmTM Detection The world’s

smallest, most accurate ICM

Page 2: EXPERIENCE THE REVEAL LINQ ADVANTAGE...Exclusive solutions that offer new freedom to focus on patients Actionable data to diagnose and treat ... Diener HC, Passman RS, et al. Cryptogenic

UNMATCHED ACCURACY Device innovations that provide leading detection accuracy

SUPERIOR EVIDENCE Clinical rigor that guides decisions across multiple conditions

SIMPLIFIED MONITORING Exclusive solutions that offer new freedom to focus on patients

Actionable data to diagnose and treat even the most difficult-to-detect arrhythmias

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

SIMPLEMinimally invasive, simplified insertion procedure

3 YEARSUp to 3-year longevity for long-term monitoring1

THE REVEAL LINQ™

SYSTEMADVANTAGE

AN ADVANCED MONITORING SOLUTION

MyCareLink™

Patient Monitor

Cellular

CareLink™ Network and Reports

Reveal LINQ ICM MR Conditional at 1.5 and 3.0 Tesla

Wireless

DEVICE LONGEVITY THAT OPTIMIZES DIAGNOSTIC YIELD

Syncope diagnoses occur after 2 years3

20%

Reveal LINQTM ICMwith TruRhythmTM Detection

30%Cryptogenic Stroke AF diagnoses occur after 2 years2

Long-term, continuous data for ongoing AF management

Page 3: EXPERIENCE THE REVEAL LINQ ADVANTAGE...Exclusive solutions that offer new freedom to focus on patients Actionable data to diagnose and treat ... Diener HC, Passman RS, et al. Cryptogenic

Advanced AF detection* Reveal LINQ ICM4

Confirm™ ICM5

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

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

Smart filtering NEW second sensing filter analyzes rhythms for possible undersensing in Brady and Pause

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

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

Streamlined Episode Review

AF

Fals

e Po

siti

ve %

39.3%Confirm ICM5

26.3%

BioMonitor 2-AF6

9.6%Reveal LINQ7

4.7%

Reveal LINQ with TruRhythm Detection4

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

AF

&BRADY

PAUSE

UNMATCHED ACCURACY

AF BURDEN (Gross)

Sensitivity 98.9% 83.8% NoPublishedDataPPV 99.0% 93.5%

AF EPISODE (Pt Avg)

Sensitivity 99.7% 95.6%

PPV 95.3% 60.7%

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

2007 2011 2014 2017

NEW AF algorithm and improved noise discrimination

NEW algorithms with

§ Smart filtering § Self-learning

intelligence

8X fewer false positives 4,5

*In known AF patients.

Confirm Rx™ ICM

Page 4: EXPERIENCE THE REVEAL LINQ ADVANTAGE...Exclusive solutions that offer new freedom to focus on patients Actionable data to diagnose and treat ... Diener HC, Passman RS, et al. Cryptogenic

SUPERIOR EVIDENCE

MOST STUDIED Evidence portfolio that includes 500+ published clinical articles and abstracts8

MOST VALIDATED Clinical validation across Cryptogenic Stroke, Syncope, and Atrial Fibrillation2,7,9

MOST UTILIZEDData leveraged by clinical societies to develop treatment guidelines across indications10,11

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

84.5%AF detection rate at 30 months.40%

ATRIAL FIBRILLATION Reveal AF Study12

AF detection increases over time for patients at high risk for AF and stroke.

is the median time to AF detection in Cryptogenic Stroke patients

84 DAYS

of patients who had AF would have been missed if only monitored for 30 days.

88%

CRYPTOGENIC STROKE CRYSTAL AF Study2

Short- and intermediate-term cardiac monitoring may miss many patients with paroxysmal AF.

2016 ESC Guidelines for the Management of AF10

Long-term insertable cardiac monitoring recommended for cryptogenic stroke patients to document silent AF.

SYNCOPE PICTURE Study9

Reveal ICMs demonstrated success in diagnosing patients with unexplained syncope.

of patients experienced a recurrence within one year.38%

of recurrent syncope patients had a Reveal ICM guided diagnosis

78%

2009 ESC Guidelines for the Management of Syncope11

Insertable cardiac monitoring recommended patients with recurrent syncope of uncertain origin.

Page 5: EXPERIENCE THE REVEAL LINQ ADVANTAGE...Exclusive solutions that offer new freedom to focus on patients Actionable data to diagnose and treat ... Diener HC, Passman RS, et al. Cryptogenic

SIMPLIFIED MONITORING

FREEDOM TO FOCUS ON BETTER PATIENT CAREExclusive solutions keep you connected to your patients, while turning device data into actionable insights.

APP-BASED INSERTION WORK FLOW

Reveal LINQ Mobile Manager

MORE EFFICIENT DATA MANAGEMENT Enhanced CareLink™ Network

A VIRTUAL EXTENSION OF YOUR CLINICAL TEAM FocusOn™ Monitoring and Triaging Service

Turn data into timely, actionable insights, that free hospital clinical teams to spend more time treating patients.

Manage device registration, activation, CareLink™ pre-enrollment and patient education — right from your tablet.

Move critical transmissions to the forefront and assess/adjudicate episodes right from the improved Quick Look™ page.

Page 6: EXPERIENCE THE REVEAL LINQ ADVANTAGE...Exclusive solutions that offer new freedom to focus on patients Actionable data to diagnose and treat ... Diener HC, Passman RS, et al. Cryptogenic

References 1 Reference the Reveal LINQ ICM Clinician Manual for usage parameters. 2 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. 3 Furukawa T, Maggi R, Bertolone C, Fontana D, Brignole M. Additional diagnostic value of very prolonged observation by

implantable loop recorder in patients with unexplained syncope. J Cardiovasc Electrophysiol. January 2012;23(1):67-71. 4 TruRhythm Detection Algorithms. Medtronic data on file. 2017. 5 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. 6 Biotronik BioMonitor 2 Clinical Manual. 2016. 7 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. 8 Medtronic Reveal Publications. Medtronic data on file. 2016. 9 Edvardsson N, Frykman V, van Mechelen 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. 10 Kirchhof P, Benussi, S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration

with EACTS. Eur Heart J. October 7, 2016;37(38):2893-2962. 11 Moya A, et al. Guidelines for the diagnosis and management of syncope (Version 2009). Eur Heart J. Presented

at ESC 2009. 12 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.

BRIEF STATEMENTSee 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 localMedtronic representative 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.

www.medtronic.com/manuals

PROGRAM REVEAL LINQ ICM

ENROLL PATIENT INTO THE CARELINK NETWORK

INSERT REVEAL LINQ ICM

EDUCATE PATIENT

PREPARE FOR INSERTION

CONNECT REVEAL LINQ ICM TO MYCARELINK MONITOR

PATIENT

FOCUSONMONITORING AND TRIAGING SERVICE CENTER

PHYSICIAN ACTION

REVEAL LINQ WORK FLOW

Page 7: EXPERIENCE THE REVEAL LINQ ADVANTAGE...Exclusive solutions that offer new freedom to focus on patients Actionable data to diagnose and treat ... Diener HC, Passman RS, et al. Cryptogenic

EXPERIENCETHE REVEAL LINQ™

ADVANTAGEReveal LINQTM

Insertable Cardiac Monitoring Systemwith TruRhythmTM Detection

UNMATCHED ACCURACY

SIMPLIFIED MONITORING

SUPERIOR EVIDENCE

The world’s smallest, most accurate ICM

medtronic.eu

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