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EXPERIENCE THE REVEAL LINQ ADVANTAGE - …

EXPERIENCETHE REVEAL LINQ ADVANTAGER eveal LINQTMI nsertable Cardiac Monitorwith TruRhythmTM DetectionThe world s smallest, most accurate ICM1 UNMATCHED ACCURACY Device innovations that provide leading detection accuracySUPERIOR EVIDENCE Clinical rigor that guides decisions across multiple conditionsSIMPLIFIED MONITORING Exclusive solutions that offer new freedom to focus on patientsActionable data to diagnose and treat even the most difficult-to-detect arrhythmiasSMALLOne-third the size of a AAA battery ( cc)SIMPLEM inimally invasive, simplified insertion procedure3 YEARSUp to 3-year longevity for long-term monitoring2 THE REVEAL LINQ SYSTEMADVANTAGEAN ADVANCED MONITORING SOLUTIONMyCareLink Patient MonitorCellularCareLink Network and ReportsReveal LINQ ICM MR Conditional at and TeslaWirelessDEVICE LONGEVITY THAT OPTIMIZES DIAGNOSTIC YIELDS yncope diagnoses occur after 2 years420% REVEAL LINQTM ICMwith TruRhythmTM Detection30%Cryptogenic Stroke AF diagnoses occur after 2 years3 Long-term, continuous data for ongoing AF m

EXPERIENCE. THE REVEAL LINQ ™ ADVANTAGE. Reveal LINQ. TM. Insertable Cardiac Monitor. with TruRhythm. TM. Detection. The world’s . …

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Transcription of EXPERIENCE THE REVEAL LINQ ADVANTAGE - …

1 EXPERIENCETHE REVEAL LINQ ADVANTAGER eveal LINQTMI nsertable Cardiac Monitorwith TruRhythmTM DetectionThe world s smallest, most accurate ICM1 UNMATCHED ACCURACY Device innovations that provide leading detection accuracySUPERIOR EVIDENCE Clinical rigor that guides decisions across multiple conditionsSIMPLIFIED MONITORING Exclusive solutions that offer new freedom to focus on patientsActionable data to diagnose and treat even the most difficult-to-detect arrhythmiasSMALLOne-third the size of a AAA battery ( cc)SIMPLEM inimally invasive, simplified insertion procedure3 YEARSUp to 3-year longevity for long-term monitoring2 THE REVEAL LINQ SYSTEMADVANTAGEAN ADVANCED MONITORING SOLUTIONMyCareLink Patient MonitorCellularCareLink Network and ReportsReveal LINQ ICM MR Conditional at and TeslaWirelessDEVICE LONGEVITY THAT OPTIMIZES DIAGNOSTIC YIELDS yncope diagnoses occur after 2 years420% REVEAL LINQTM ICMwith TruRhythmTM Detection30%Cryptogenic Stroke AF diagnoses occur after 2 years3 Long-term.

2 Continuous data for ongoing AF management Advanced AF detection* REVEAL LINQ ICM5 Confirm ICM6 DRIVING ACCURACY EVOLUTION Dedicated to advancing accuracy with every device TRURHYTHM DETECTION Our newest detection algorithms streamline episodes without sacrificing filtering NEW second sensing filter analyzes rhythms for possible undersensing in Brady and PauseSelf-learning NEW AF algorithm learns and adapts to patients with sinus arrhythmiaSUPERIOR ACCURACY IN AF DETECTION Demonstrating superior atrial fibrillation detection accuracy through our performance Episode ReviewAF False Positive % LINQ with TruRhythm Detection5 % of False Positives = (1 Episode PPV). Episode PPV may vary (gross, patient average).

3 AF&B R ADYPAUSEUNMATCHED ACCURACYAF BURDEN (Gross) EPISODE (Pt Avg) XTIndustry s first AF detection algorithmReveal XTReveal LINQ TruRhythm DetectionAFAFPAUSENEW Pause algorithm with diminishing R-wave analysisNEW AF algorithm with increased accuracyAFAF&BR ADYPAUSE2009 2011 2014 2017 NEW AF algorithm and improved noise discriminationNEW algorithms with Smart filtering Self-learning intelligence8X fewer false positives 5,6*In known AF EVIDENCEMOST 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.

4 12 of patients with AF would have been missed if only monitored for 30 detection rate at 30 months40%ATRIAL FIBRILLATION REVEAL AF Study13AF detection increases over time for patients at high risk for AF and the median time to AF detection in Cryptogenic Stroke patients84 DAYSof patients who had AF would have been missed if only monitored for 30 days88%CRYPTOGENIC STROKE CRYSTAL AF Study3 Short- and intermediate-term cardiac monitoring may miss many patients with paroxysmal ESC Guidelines for the Management of AF11 Long-term insertable cardiac monitoring recommended for cryptogenic stroke patients to document silent PICTURE Study10 REVEAL ICMs demonstrated success in diagnosing patients with unexplained patients experienced a recurrence within one year38%of recurrent syncope patients had a REVEAL ICM guided diagnosis78%2017 ACC/AHA/HRS Guidelines for the Management of Syncope12 Insertable cardiac monitoring recommended for syncope patients based on frequency and nature of MONITORINGFREEDOM TO FOCUS ON BETTER PATIENT CAREE xclusive solutions keep you connected to your patients.

5 While turning device data into actionable INSERTION WORK FLOWR eveal LINQ Mobile ManagerMORE EFFICIENT DATA MANAGEMENTE nhanced CareLink NetworkA VIRTUAL EXTENSION OF YOUR CLINICAL TEAMR eveal LINQSM Monitoring ServiceStreamline 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 critical transmissions to the forefront and assess/adjudicate episodes right from the improved Quick Look 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.

6 P atients with clinical syndromes or situations at increased risk of cardiac arrhythmias P atients 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 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.

7 The patient connector is intended to be used by healthcare personnel only in a clinical or hospital 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 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.

8 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 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 of wireless devices The patient connector incorporates radiofrequency (RF) communications components which may affect other devices and equipment in the medical environment.

9 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 (RF) interference Portable and mobile RF communications equipment can interfere with the operation of the patient connector.

10 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 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.


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