References1 Krahn AD, Klein GJ, Yee R, Skanes AC. Randomized assessment of syncope trial: Conventional diagnostic testing versus a prolonged

monitoring strategy. Circulation. 2001;104:46-51.2 Krahn AD, Klein GJ, Yee R, Skanes AC. Syncope: Experience with the implantable loop recorder. ACC Current J Rev. 1999;80-84.3 Krahn AD, Klein GJ, Yee R, et al. Cost implications of testing strategy in patients with syncope (RAST). J Am Coll Cardiol. 2003;42:495-501.4 ACC/AHA Class I Indications for Ambulatory ECG. 5 Zaidi A, Clough P, Cooper P, et al. Misdiagnosis of epilepsy: Many seizure-like attacks have a cardiovascular cause. JACC.

July 2000;36(1):181-184.6 Kapoor WN. Diagnostic evaluation of syncope. Am J Med. 1991:(1):91-106. 7 Krahn AD, Klein GJ, Yee R. Recurrent syncope-Experience with an implantable loop recorder. Cardiol Clin. 1997;15(2):313-326. 8 Kapoor WN. Evaluation and outcome of patients with syncope. Medicine. 1990;69:160-175.9 Kapoor WN. Evaluation and management of the patient with syncope. JAMA. 1992;268:2553-2560. 10 Linzer M, Yang EH, Estes NA 3rd, et al. Diagnosing syncope. Part 2: Unexplained syncope. Clinical Efficacy Assessment Project of the

American College of Physicians. Ann Int Med. 1997;127(1):76-86. 11 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. 1998;82(1):117-119. 12 Krahn AD, Klein GJ, Yee R, et al. Use of extended monitoring strategy in patients with problematic syncope. Circulation. 1999;99:406-410.

Brief Statement

Indications Model 9526 Reveal® Plus Insertable Loop Recorder The Reveal Plus ILR is an implantable patient- and automatically activated monitoring system that records subcutaneous ECG and is indicated for • Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias • Patients who experience transient symptoms that may suggest a cardiac arrhythmia Model 6191 Activator The Model 6191 Activator is intended for use in combination with a Medtronic Model 9526 Reveal Plus Insertable Loop Recorder. Contraindications There are no known contraindications for the implantation of the Reveal Plus ILR. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. Warnings/Precautions Model 9526 Reveal Plus Insertable Loop Recorder Patients with the Reveal Plus ILR should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing. Model 6191 Activator Operation of the Model 6191 Activator near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device. Potential Complications Potential complications include, but are not limited to, body tissue rejection phenomena, including local tissue reaction, infection, device migration and erosion of the device through the skin. 2090 Programmer The Medtronic/Vitatron CareLink® Programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the appropriate programmer software and implantable device technical manuals for more information related to specific implantable device models. Programming should be attempted only by appropriately trained personnel after careful study of the technical manual for the implantable device and after careful determination of appropriate parameter values based on the patient’s condition and pacing system used. The Medtronic/Vitatron CareLink Programmer must be used only for programming implantable devices manufactured by Medtronic or Vitatron. 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 Medtronic’s website at www.medtronic.com. To learn more about syncope, visit www.fainting.com. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

REVEAL® PLUSInsertable Loop Recorder

Uncovering the Symptom-Rhythm Correlation

World HeadquartersMedtronic, Inc.710 Medtronic ParkwayMinneapolis, MN 55432-5604USATel: (763) 514-4000Fax: (763) 514-4879www.medtronic.com

Medtronic USA, Inc.Toll-free: 1 (800) 328-2518(24-hour technical support for physicians and medical professionals)

EuropeMedtronic Europe SàrlRoute du Molliau 31CH-1131 TolochenazSwitzerlandTel: (41 21) 802 7000Fax: (41 21) 802 7900www.medtronic.com

CanadaMedtronic of Canada Ltd.6733 Kitimat RoadMississauga, Ontario L5N 1W3CanadaTel: (905) 826-6020Fax: (905) 826-6620Toll-free: 1 (800) 268-5346

Asia PacificMedtronic International, Ltd.16/F Manulife PlazaThe Lee Gardens, 33 Hysan AvenueCauseway BayHong KongTel: (852) 2891 4456Fax: (852) 2891 6830enquiryap@medtronic.comwww.medtronic.com

Latin AmericaMedtronic USA, Inc.Doral Corporate Center II3750 NW 87th Avenue Suite 700Miami, FL 33178USATel: (305) 500-9328Fax: (786) 709-4244www.medtronic.com

UC200503928 EN© Medtronic, Inc. 2005All Rights ReservedPrinted in USAOctober 2005

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Get Information, Get Answers, and Uncover the Symptom-Rhythm Correlation Reveal® Plus is the only long-term monitoring tool availableto assist you in the diagnosis of patients at increased risk of cardiac arrhythmias.

Reveal Plus• Records subcutaneous ECG for up to 14 months• Provides high diagnostic yield (43-88%)1-3

– Twice the diagnostic yield of conventional testing in patients with unexplained syncope3

• May help rule in and rule out cardiac arrhythmias• May uncover both symptomatic and asymptomatic episodes• Is designed to improve patient acceptance and compliance

Who Benefits from this Monitoring System?

Patients with clinical syndromes or situations at increased risk for arrhythmias,* including patients with4,5

• Unexplained syncope• Near syncope• Episodic, recurrent palpitations• Drug-refractory epilepsy, seizure-like events and convulsions

Actual Size 8 cc , 17 g

CASE STUDY

* The Reveal Plus ILR is also indicated for patients with transient symptoms that may suggest cardiac arrhythmias.

Patient History• 44-year-old male, construction superintendent

• No structural heart disease

• 5 episodes of syncope/near syncope over 7 months, episodes of dizziness

• Hospitalized twice; 2 car accidents with loss of driving privileges and work restrictions

Diagnostic Testing2 Holter Monitor Tests Both negativeCarotid Sinus Massage Negative2 Tilt Table Tests 1 normal, 1 abnormal Echo NormalElectrophysiological Study (EPS) Negative

• A Reveal Plus ILR was implanted• One month post-implant, the ILR automatically captured asystole (> 10 seconds)• A pacemaker was implanted and symptoms resolved – the patient regained his

independence

7:27:41

7:27:50

7:27:59

7:28:08A

7:28:17

7:28:26

SummaryCarotid sinus syndrome was ruled out. Tilt-table testing results were mixed. In the absence of structural heart disease, an EPS did not aid syncope diagnosis. The ILR proved to be a useful tool to diagnose unexplained symptoms and select appropriate therapy.

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Simple Implant, Simple Follow-Up

• Leadless • Subcutaneous placement• Short, minimally invasive outpatient procedure• Requires only local anesthesia • In-office device programming and data retrieval using the

Medtronic programmer

Reveal Plus Activator(available with carrying case)

Automatic Detection Options• Bradycardia • Tachycardia • Asystolic pauses

PatientActivation

Point

AutoActivation

Point

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TEST/PROCEDURE YIELD*

ECG 2-11%6

Holter Monitoring 2%7

External Loop Recorder 20%7

Reveal® Plus ILR 43-88%3,11,12

Tilt Table Test** 11-87%8,9

EP Study** without SHD*** 11%10

EP Study** with SHD*** 49%8

Neurological Testing (CT scan, carotid doppler) 0-4%8,9

Compare Diagnostic Yields

Some testing options are limited in their ability to capture infrequent events. Due to the complex diagnosis of syncope, it’s important to use the monitoring option that can provide clear information.

More Information, Accurate Diagnoses

• 42 minutes of stored data• Patient-activated mode – Captures ECG during symptoms – Stores information before, during, and after activation• Automatic detection mode – Uses programmable rate limits – May reveal asymptomatic episodes – Provides a second opportunity to capture events in patients who

have difficulty using external devices

Patient and Auto Activation Modes

Patient Activation Modes

* Data compression allows 42 minutes storage time.** Auto activation: Choice of recording first 14 or last 13 events.*** Auto activation: Choice of recording first 6 or last 5 events.

40 min

12 min

2 min

12 min

8 min 2 min

1 min pre/1 min post

*

2 min

2 min

*

*

*

**

Patient ActivationAuto ActivationPre-Patient ActivationPre-Auto ActivationPost Activation

***

* Based on mean diagnosis time of 5.1 mos.7

** Provocative test *** SHD structural or organic heart disease

Diagnostic Yield in Unexplained Syncope Patients

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