Overview Brochure

REVEAL® PLUS Insertable Loop Recorder

Product Overview

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

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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 canprovide the critical evidence to guide informed decisions.

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


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

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 orrule out life-threatening arrhythmias.


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

* Based on mean time to syncope of 5.1 months12

** Provocative test

*** SHD structural or organic heart disease

Improved Diagnosis

Diagnostic Yield in Unexplained Syncope Patients

Test/procedure Yield

ECG 2-11% 11

Holter monitoring 2% 12

External Loop Recorder 20% 12

Reveal Plus* 43-88% 13-15

Tilt Table Test** 11-87%16,17

EP Study** without SHD*** 11% 18

EP Study** with SHD*** 49% 16

Neurological Testing (CT scan, carotid doppler) 0-4% 16,17


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

Cost-Effectiveness

Reveal Plus monitoring precedes conventional testing

Conventional testing precedes Reveal Plus monitoring

100%

80%

60%

40%

20%

0%Cost per Patient Cost per Diagnosis

100%

80%

100%

74%

P = 0.013 P = 0.002

Rela

tive

Cos

t

Randomized Assessment of Syncope Trial:Results of Conventional versus ILR Testing Strategies13

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


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

Simplicity

Patient Activation Modes 40 min 2 min

12 min 2 min

Patient and Auto Activation Modes 12 min 2 min 1 min pre/1 min post ** 8 min 2 min ***

Patient Activation Auto Activation Pre-Patient Activation Pre-Auto Activation Post Activation

* 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.

*

*

*

*


Patient HistoryA 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 patient’s medical history was unremarkable with no history of coronary heart disease.

Diagnostic TestingCoronary 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 TreatmentAuto activation mode captured this nine-second pause during the patient’s third syncopal episode. After pacemaker implantation, the patient returned to work – free of symptoms.

ConclusionSyncope can prove especially challenging when a patient’s 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.

Informed Decisions

AutoActivation

Point


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

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)

Subcutaneous Diagnostics and MonitoringPO Box 52276802 EE ArnhemThe NetherlandsTel: +31 (0) 26 376 7777Fax: +31 (0) 26 376 7666www.medtronic.com

EuropeMedtronic International Trading 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 [email protected]

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

References1 National Disease and Therapeutic Index on Syncope and Collapse, ICD-9-CM ISC#780.2.

IMS America. 2006.2 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 Scientifi c 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 Effi cacy 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 offi ce-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 specifi c therapy in patients with recurrent suspected neurally mediated syncope. Eur Heart J. May

2006;27(9):1085-1092.

Brief Statement

Indications9526 Reveal® Plus Insertable Loop RecorderThe 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 ActivatorThe Model 6191 Activator is intended for use in combination with a Medtronic Model 9526 Reveal Plus Insertable Loop Recorder.

ContraindicationsThere 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/Precautions9526 Reveal Plus Insertable Loop RecorderPatients with the Reveal Plus ILR should avoid sources of magnetic resonance imaging, diathermy, high sources of radiation, electrosurgical cautery, external defi brillation, lithotripsy, and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing.

6191 ActivatorOperation 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 ComplicationsPotential 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 specifi c 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.

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

UC200701155 EN© Medtronic, Inc. 2006All Rights ReservedPrinted in USAOctober 2006


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Overview Brochure