experience the reveal linq advantage...reveal linq mobile manager. resources to support clinic...

EXPERIENCETHE REVEAL LINQ™

ADVANTAGE

REVEAL LINQ™INSERTABLE CARDIAC MONITORAN OVERVIEW

REVEAL™ ICM PRODUCT EVOLUTION

1998:Reveal

2000:Reveal Plus

2007: Reveal DX

2007: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 batteryAdded to the

Medtronic CareLink™ NetworkMR-conditional

3-year batteryAF detection

algorithmCardiac 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 ADVANTAGESPOWERFUL CARDIAC MONITORING

Indications for useThe 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 ADVANTAGESPOWERFUL CARDIAC MONITORING

ICMs are underutilizedICMs 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 AssistantInsertion Tools NEW app-based Reveal LINQ™ Mobile Manager

Solution Enablers

CareLink Network & Reports

MyCareLink™ Patient Monitor

Reveal LINQ ICM Wireless Cellular

FOCUSON™ Data Monitoring & Triaging Service

REVEAL LINQ SYSTEM ADVANTAGESAN ADVANCED MONITORING SOLUTION


REVEAL LINQ SYSTEM ADVANTAGESREVOLUTIONIZING 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 ADVANTAGESSIMPLE 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 min6.5 min prior

REVEAL LINQ SYSTEM ADVANTAGESSMART ECG DATA STORAGE

ECG data storage: 59 minutes totalPatient-activated: up to 30 minutes


REVEAL LINQ SYSTEM ADVANTAGESSMART ECG DATA STORAGE

ECG data storage: 59 minutes totalAutomatically 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.


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REVEAL LINQ SYSTEM ADVANTAGESTRANSFORMING CARDIAC MONITORING

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

PROVENACCURACY

CLINICALRIGOR

ADVANCEDMONITORING

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

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REVEAL LINQ SYSTEM ADVANTAGESPROVEN 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


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PROVEN ACCURACYDURATION-BASED PERFORMANCE METRICS

Reveal LINQ AF monitoringDuration-based performance metrics898.4%

SENSITIVITY

99.5%SPECIFICITY

99.4%ACCURACY

97.2%PPV

99.7%NPV

Comparison of AF burden detected by ICM and Holter


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PROVEN ACCURACYPATIENT AND EPISODE-BASEDPERFORMANCE METRICS

Reveal LINQ AF monitoringPatient- 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 ACCURACYAF 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

Fals

e Po

siti

ve R

ate*

0%25

%

9.6%

26.3%

40.9%


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

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PROVEN ACCURACYAT/AF SUMMARY REPORT

Provides an overview of all atrial arrhythmias detected, including: % of time in AT/AF

Average time in AT/AFper day

Number of episodes at a given duration

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


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PROVEN ACCURACYREVEAL 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


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CLINICAL RIGOREVIDENCE 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 RIGORCRYPTOGENIC STROKE

Diagnosis of AF in stroke patientchanges treatment protocol

AF Affects 1-2% of the population.18

AF increases the risk of stroke 5×.19

Treatment with Oral Anti-coagulation (OAC)Therapy reduces the likelihood of experiencing stroke by 67.20

Stroke is the predominant cause of mortality and morbidity in patients with AF.19

61%of patients who had both AF and a stroke did not know they had AF prior to their stroke19


1/3of Ischemic Strokes are Cryptogenic21

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×

84Percent of patients prescribed OAC once AF was detected9

97%

7X



Real-world practice with Reveal LINQ ICMSuperiority 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 RIGORSYNCOPE

40% of the population will experience syncope22

Cardiac syncope doubles the risk of death

MORTALITY

Cardiac condition doubles the risk of death and increasesthe 6-month mortality rate by 10%23

MAGNITUDE

3-5% of all ER visits24

1-3% of all hospitalizations24

UNDIAGNOSED

50% of all patients leave the hospital without a diagnosis25

FRUSTRATION

13 different tests during diagnosis period10

Syncope patient visits 3 specialists on average10


22


Limited yield of many diagnostic testsDiagnostic 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

gnos

tic

Yie

ld*


26 27

11

28 29

30

10

*Based on mean diagnosis time of 5.1 mos.

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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-hospitaltelemetric monitoring

48-72 h Holter, in-hospitaltelemetric monitoring

7 days Holter or external loop recorder

14-30 days external loop recorder

Implantable loop recorder

Monitoring Choice by Patient Risk2


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CLINICAL RIGORATRIAL FIBRILLATION

SUSPECTED AF MONITORINGContinuous monitoring can reveal AF

Symptoms are not a good indicator for presence of AF31-35

Continuous monitoring with ICMs can identify AF in patients at high risk36,37

Study Method of Monitoring % Asymptomatic AF

Page et al. 199431 External monitors:1 day/week (5×)

92.3% of episodes

Strickberger et al. 200532

Implantable Pacemakers 94% of episodes

Quirino et al. 200933 Implantable Pacemakers 81% of episodes

Orlov et al. 200734 Implantable Pacemakers 94.7% of episodes

Verma et al. 201335 Implantable Loop Recorders 79% of episodes

22% of a patient population at high risk was found to have > 6min of AF within 12 months37


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CLINICAL RIGORATRIAL FIBRILLATION

AF MANAGEMENTOptimize 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. 38,39

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


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ADVANCED MONITORINGINNOVATIVE 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, 40-42

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


FOCUSON™Data Monitoring & Triaging Service

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ADVANCED MONITORINGNEW 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.comfor the most up-to-date list of supported tablets

WI-FI OR CELLULAR CONNECTION

MEDTRONIC PATIENT CONNECTOR

DOWNLOAD APP ON SUPPORTED TABLET


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ADVANCED MONITORINGCLINICALLY ACTIONABLE REPORTSEasy-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.

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ADVANCED MONITORINGCLINICALLY ACTIONABLE REPORTS

Easy-to-use, clinically actionable reports6

The information you need when you need it

Event ReportData may help in timely management of patients.

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

Summary ReportData may help in routine management of patients.

Full ReportManual transmission from patient when you need to know more.


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ADVANCED MONITORINGNEW CLINICIAN LEARNING PLAN

New clinician learning plan on Medtronic AcademySupports 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.


Access learning plan at: MedtronicAcademy.com/LINQMonitoring

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ADVANCED MONITORINGNEW FOCUSONTM

MONITORING AND TRIAGING SERVICE


Remote monitoring of patientsThe CareLink™ Network receives data from patients with Reveal LINQ™ ICM and other implanted devices.

Monitoring and Triaging Service Monitors all data received by CareLink™, triages what needs attention and action, alerting and sending reports to hospital Clinical Teams.

Hospital Clinical TeamsFreed of data overload, hospital Clinical Teams have more time to spend with patients.

FOCUSONTM monitors and triages data, freeing up time for hospital Clinical Teams

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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. A. John Camm et. al. Guidelines for the management of atrial fibrillation; European Heart Journal (2010) 31, 2369–2429 doi:10.1093/eurheartj/ehq27819. 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-e113.20. Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. August 1991;84(2):527-539.21. 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):35-41.22. Kenny RA., et al. Futura;2003:23-27.23. Soteriades ES, Evans JC, Larson MG, et al. Incidence and prognosis of syncope. N Engl J Med. September 19, 2002; 347(12):878-885.24. 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):815-820.25. 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.

http://www.abstractsonline.com/pp8/#!/4046/presentation/8072

http://clinicaltrials.gov/

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

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REFERENCES


26. Atkins D, Hanusa B, Sefcik T, et al. Syncope and orthostatic hypotension. Am J. Med. 1991;91,179-185.27. Krahn, AD, Klein, GJ, Yee, R. Recurrent syncope: experience with an implantable loop recorder. Cardiol Clin. 1997;15:313–326. 28. Linzer, M., et al. Diagnosing Syncope. Ann Intern Med. 1997;126:989-996.29. Kapoor, WN. Evaluation and outcome of patients with syncope. Medicine. 1990;69(3):160-175.30. Kapoor, WN. Evaluation and Management of the Patient With Syncope. JAMA. 1992;11:268 (18):2553-2560.31. 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):224-227.32. Strickberger A, Ip J, Saksensa S, et al. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. Feb. 2005; 2(2):125-131.33. 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; 32:91-98.34. 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; 30:404-411.35. 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):149-156.36. 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):1217-1222.37. 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.

38. 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.

39. 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.

40. 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.

41. 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.

42. 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.

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

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BRIEF STATEMENT

Brief StatementSee the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events.