REVEAL PLUS Insertable Loop Recorder

Product Overview

Imagine . . .
. . . finding answers for your syncope patients

Informed Decisions
Syncope is often difficult to diagnose, can lead to serious injury, and, in some cases, increases the risk of sudden death. When a diagnosis is uncertain, a correlation between symptoms and an ECG record can provide the critical evidence to guide informed decisions.

Syncope Facts High incidence: There are more than 1.5 million syncope patients per year in the United States alone1 Often unexplained: The cause of syncope is unknown in almost 40% of cases2 Increased risk: People with cardiac syncope have a six-month mortality rate of greater than 10%2 An issue in the elderly: Syncope causes 10% of falls in the elderly3

Reveal Plus Insertable Loop Recorder (ILR) is the first and only implantable patient- and automatically activated cardiac monitoring system. Reveal Plus can record an ECG at the time of a syncopal episode that may rule in or rule out life-threatening arrhythmias.

Who Could Benefit from Reveal Plus? 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

Reveal Plus Specifications 14 months of continuous leadless monitoring 42 minutes of stored ECG Patient activation mode: Captures the ECG at the time of the symptom Auto activation mode: Detects asystolic pauses, bradycardia, and tachycardia Volume: 8 cc Weight: 17 g Dimensions: 61 x 19 x 8 mm

Improved Diagnosis
Reveal Plus May Diagnose Where Other Tests Fail
Studies show that the rhythm captured during a spontaneous syncopal event may not correlate to the rhythm recorded during tilt-table induced syncopal events6-8 The American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)9 and the European Society of Cardiology (ESC)10 advise the use of Reveal Plus in the management of syncope

Diagnostic Yield in Unexplained Syncope Patients Test/procedure ECG Holter monitoring External Loop Recorder Yield 2-11% 11 2% 12 20% 12

Reveal Plus*
Tilt Table Test** EP Study** without SHD*** EP Study** with SHD*** Neurological Testing (CT scan, carotid doppler)
* Based on mean time to syncope of 5.1 months12 ** Provocative test *** SHD structural or organic heart disease

43-88% 13-15
11-87%16,17 11% 18 49% 16 0-4% 16,17

Cost-Effectiveness
Early Use of Reveal Plus May Reduce Syncope Diagnosis Costs
The cost of a primary ILR strategy is 26% less than that of conventional testing in the diagnosis of recurrent, unexplained syncope13 Reveal Plus-based treatments may lead to fewer hospitalization days when compared to conventional testing-based treatments19

Randomized Assessment of Syncope Trial: Results of Conventional versus ILR Testing Strategies13
P = 0.013 100% 80% 80% 100% P = 0.002 100% Reveal Plus monitoring precedes conventional testing Conventional testing precedes Reveal Plus monitoring

74%

Relative Cost

60% 40% 20% 0%

Cost per Patient

Cost per Diagnosis

Cost per diagnosis was significantly reduced when the ILR was used as the primary monitoring strategy.

Simplicity
Reveal Plus Is Simple to Implant and Follow Up
Reveal Plus can be implanted in a short, minimally invasive outpatient procedure With no restrictions due to external wires or recording pads, Reveal Plus is designed to improve patient compliance During a syncopal episode, the ECG is captured via the one-touch patient activator or the pre-programmed automatic activation option Data is easily retrieved and analyzed via the Medtronic programmer

Patient Activation Modes

40 min * 12 min * 2 min 2 min

Patient and Auto Activation Modes

12 min * 8 min *
Patient Activation Auto Activation Pre-Patient Activation Pre-Auto Activation Post Activation

2 min 2 min

1 min pre/1 min post ** ***

* 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.

Informed Decisions
Patient History
A 42-year-old truck driver had two syncopal events over several months the second event occurred while driving and prevented him from returning to work. The patients medical history was unremarkable with no history of coronary heart disease.

Diagnostic Testing
Coronary Angiogram Negative Carotid Sinus Massage Negative Tilt Table Test (standard) Negative Tilt Table Test with Isoproterenol Negative EP Study Negative A Reveal Plus was implanted

Results and Treatment

Auto activation mode captured this nine-second pause during the patients third syncopal episode. After pacemaker implantation, the patient returned to work free of symptoms.

Auto Activation Point

Conclusion
Syncope can prove especially challenging when a patients history and physical provide few clues. As shown here, as well as in recent clinical studies, Reveal Plus can help diagnose patients with and without structural heart disease.13,20,21 Results may vary. Not every patient responds to therapy the same way.

For more information: www.MedtronicConnect.com or www.fainting.com

References
1

National Disease and Therapeutic Index on Syncope and Collapse, ICD-9-CM ISC#780.2. IMS America. 2006. Soteriades ES, Evans JC, Larson MG, et al. Incidence and prognosis of syncope. N Engl J Med. September 19, 2002;347(12):878-885. 3 Campbell AJ, Reinken J, Allan BC, Martinez GS. Falls in old age: a study of frequency and related clinical factors. Age Ageing. November 10, 1981;10(4):264-270. 4 ACC/AHA Class I Indications for Ambulatory ECG. 5 Zaidi A, Clough P, Cooper P, Scheepers B, Fitzpatrick AP. Misdiagnosis of epilepsy: many seizure-like attacks have a cardiovascular cause. J Am Coll Cardiol. July 2000;36(1):181-184. 6 Deharo JC, Jego C, Lanteaume A, Djiane P. An implantable loop recorder study of highly symptomatic vasovagal patients: the heart rhythm observed during a spontaneous syncope is identical to the recurrent syncope but not correlated with the head-up tilt test or adenosine triphosphate test. J Am Coll Cardiol. February 7, 2006;47(3):587-593. 7 Moya A, Brignole M, Menozzi C, et al. International Study on Syncope of Uncertain Etiology (ISSUE) Investigators. Mechanism of syncope in patients with isolated syncope and in patients with tilt-positive syncope. Circulation. September 11, 2001;104(11):1261-1267. 8 Brignole M, Sutton R, Menozzi C, Garcia-Civera R, Moya A, Wieling W. Lack of correlation between the responses to tilt testing and adenosine triphosphate test and the mechanism of spontaneous neurally mediated syncope. Eur Heart J. September 2006;27(18):2232-2239. 9 Strickberger SA, Benson DW, Biaggioni I, et al. AHA/ACCF Scientic Statement on the evaluation of syncope: from the American Heart Association Councils on Clinical Cardiology, Cardiovascular Nursing, Cardiovascular Disease in the Young, and Stroke, and the Quality of Care and Outcomes Research Interdisciplinary Working Group; and the American College of Cardiology Foundation: in collaboration with the Heart Rhythm Society: endorsed by the American Autonomic Society. Circulation. January 17, 2006;113(2):316-327. 10 Brignole M, Alboni P, Benditt DG, et al. Guidelines on management (diagnosis and treatment) of syncope update 2004. Europace. November 2004;6(6):467-537. 11 Kapoor, WN. Diagnostic evaluation of syncope. Am J Med. January 1991;90(1):91-106. 12 Krahn AD, Klein GJ, Yee R. Recurrent syncope: Experience with an implantable loop recorder. Cardiol Clin. May 1997;15(2):313-326. 13 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 2003;42(3):495-501. 14 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 1998;82(1):117-119. 15 Krahn AD, Klein GJ, Yee R, Takle-Newhouse T, Norris C. Use of an extended monitoring strategy in patients with problematic syncope. Reveal Investigators. Circulation. January 26, 1999;99(3):406-410. 16 Kapoor WN. Evaluation and outcome of patients with syncope. Medicine (Baltimore). May 1990;69(3):160-175. 17 Kapoor WN. Evaluation and management of the patient with syncope. JAMA. November 11, 1992;268(18):2553-2560. 18 Linzer M, Yang EH, Estes NA III, Wang P, Vorperian VR, Kapoor WN. Diagnosing syncope Part 2: Unexplained syncope. Clinical Efcacy Assessment Project of the American College of Physicians. Ann Intern Med. July 1, 1997;127(1):76-86. 19 Farwell DJ, Freemantle N, Sulke N. The clinical impact of implantable loop recorders in patients with syncope. Eur Heart J. February 2006;27(3):351-356. 20 Mason PK, Wood MA, Reese DB, Lobban JH, Mitchell MA, DiMarco JP. Usefulness of implantable loop recorders in ofce-based practice for evaluation of syncope in patients with and without structural heart disease. Am J Cardiol. November 1, 2003;92(9):1127-1129. 21 Brignole M, Sutton R, Menozzi C, et al. International Study on Syncope of Uncertain Etiology 2 (ISSUE 2) Group. Early application of an implantable loop recorder allows effective specic therapy in patients with recurrent suspected neurally mediated syncope. Eur Heart J. May 2006;27(9):1085-1092.
2

Brief Statement
Indications 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 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 patients particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. Warnings/Precautions 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 debrillation, lithotripsy, and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing. 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 specic 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 patients 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 Medtronics website at www.medtronic.com. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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UC200701155 EN Medtronic, Inc. 2006 All Rights Reserved Printed in USA October 2006