EXPERIENCETHE REVEAL LINQ™

ADVANTAGEReveal LINQTM

Insertable Cardiac Monitorwith TruRhythmTM Detection The world’s

smallest, most accurate ICM1

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 monitoring2

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 years4

20%Reveal LINQTM ICMwith TruRhythmTM Detection 30%

Cryptogenic Stroke AF diagnoses occur after 2 years3

Long-term, continuous data for ongoing AF management

Advanced AF detection* Reveal LINQ ICM5

Confirm™ ICM6

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-AF6

26.3%

BioMonitor 2-AF7

9.6%Reveal LINQ8

4.7%

Reveal LINQ with TruRhythm Detection5

†% 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%

PPV 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

2009 2011 2014 2017

NEW AF algorithm and improved noise discrimination

NEW algorithms with

§ Smart filtering § Self-learning

intelligence

8X fewer false positives 5,6

*In known AF patients.

SUPERIOR EVIDENCE

MOST STUDIED Evidence portfolio that includes 500+ published clinical articles and abstracts9

MOST VALIDATED Clinical validation across Cryptogenic Stroke, Syncope, and Atrial Fibrillation3,8,10

MOST UTILIZEDData leveraged by clinical societies to develop treatment guidelines across indications11,12

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

84.5%AF detection rate at 30 months40%

ATRIAL FIBRILLATION Reveal AF Study13

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 Study3

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

2016 ESC Guidelines for the Management of AF11

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

SYNCOPE PICTURE Study10

Reveal ICMs demonstrated success in diagnosing patients with unexplained syncope.

of patients experienced a recurrence within one year38%

of recurrent syncope patients had a Reveal ICM guided diagnosis

78%

2017 ACC/AHA/HRS Guidelines for the Management of Syncope12

Insertable cardiac monitoring recommended for syncope patients based on frequency and nature of events.

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

Reveal LINQSM Monitoring Service

Streamline patient management with support from certified technicians who ensure ongoing data transmission, review cardiac data, and provide clinically actionable reports.

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.

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 arrhythmiaThe device has not been tested specifically for pediatric use.

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 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.

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.

Reveal LINQ Insertable Cardiac MonitorWarnings/PrecautionsPatients with the Reveal LINQ ICM 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.

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.

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 radiofrequency (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.

Radiofrequency (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 AssistantOperation 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 ApplicationIntended 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 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 medtronic.com.

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

References 1 ICM Competitive Comparison Guide. Medtronic data on file. 2017. 2 Reference the Reveal LINQ ICM Clinician Manual for usage parameters. 3 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. 4 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. 5 TruRhythm Detection Algorithms. Medtronic data on file. 2017. 6 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. 7 Biotronik BioMonitor 2 Clinical Manual. 2016. 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 Medtronic Reveal Publications. Medtronic data on file. 2016. 10 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. 11 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. 12 Shen WK, Sheldon RS, Benditt DG, et al. 2017 ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With

Syncope. J Am Coll Cardiol. Published online March 9, 2017. 13 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.

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.

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

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EXPERIENCETHE REVEAL LINQ™

ADVANTAGEReveal LINQTM

Insertable Cardiac Monitoring Systemwith TruRhythmTM Detection

UNMATCHED ACCURACY

SIMPLIFIED MONITORING

SUPERIOR EVIDENCE

The world’s smallest, most accurate ICM1