Reveal DX and Reveal XT Insertable Cardiac Monitors
Reveal® Insertable Cardiac Monitors capture the ECG you need to make informed decisions about patients with known or suspected arrhythmias or syncope.
Summary
With continuous ECG monitoring for up to 3 years, Reveal® Insertable Cardiac Monitors record vital information during an actual episode of syncope or an arrhythmia which can be accessed for detailed analysis.
Reveal Insertable Cardiac Monitors expand on the cardiac monitoring foundation Medtronic began more than 10 years ago with the Reveal and Reveal Plus Insertable Loop Recorders. They are also the first Insertable Cardiac Monitors to offer comprehensive remote monitoring capabilities via the Medtronic CareLink® Network. This allows easy access to diagnostic data without an office visit.
What Are the Benefits of a Reveal ICM?
- Unique diagnostic and monitoring insights with continuous monitoring of heart rate and rhythm which may help diagnose unexplained syncope and palpitations as well as atrial fibrillation
- Vital information about patients with known or suspected arrhythmias or syncope
- Continuous monitoring for up to 3 years may help confirm or rule out life-threatening arrhythmias
- Overcomes the limitations commonly found with other cardiac testing options because it captures the actual episode
- Comprehensive remote monitoring capabilities without an office visit
- Enables a patient to tag symptoms with the hand-held Patient Assistant
- Combines long-term monitoring with the safety of MR Conditional labeling*
- Ease of use from insertion to follow-up
Important Safety Information
A patient's particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.
* Reveal XT and DX have been shown to pose no known hazards in a specified MR environment with specified conditions of use. Please see the Reveal XT ICM or Reveal DX ICM Clinician Manual in the Medtronic Manual Library for more details.
Reveal DX ICM
Reveal® DX ICM captures the information you need to make informed decisions about your syncope patients who suffer from infrequent but recurrent episodes. While some causes of unexplained syncope are harmless, others may be serious. The Reveal ICM continuously monitors heart rhythms and can record an ECG at the time of fainting. In fact, infrequent unexplained syncope may be most easily evaluated by an insertable cardiac monitor.1
With continuous monitoring for up to 3 years, Reveal may help confirm or rule out life-threatening arrhythmias as the cause of recurrent but infrequent fainting. Diagnosing and treating a cardiovascular cause of syncope is important to reduce the risk of stroke or sudden cardiac arrest.
Improved Diagnosis
- May help diagnose where other tests may not have the capabilities to provide answers2,3
- Is supported by AHA/ACCF4 and ESC Guidelines*5
- May direct effective treatment with subsequent reduction in syncopal events6
- Is labeled MR-Conditional†
Enhanced Sensing and Detection
- Tracking threshold ensures reliable R-wave sensing‡
- Autoclassification by episode type:
- Bradycardia
- Asystole
- Ventricular tachyarrhythmia
- Fast ventricular tachyarrhythmia
- Patient activated with Patient Assistant (symptom-driven)
- Noise reversion and overrange detection algorithms limit false-positives
Ease of Use From Insertion to Follow-up
- Reveal Vector Check confirms positioning
- Slim, leadless device simplifies insertion
- Straightforward user interface allows for quick programming and follow-ups
- Episode log allows data sorting and viewing by rhythm type
- ECG storage includes prioritization to optimize arrhythmia identification
Long-Term Monitoring Capabilities
- 3-year monitoring may improve the likelihood of capturing infrequent episodes
- Provides diagnostic yields much greater than traditional monitoring methods7
- Lack of wires and patches designed to improve patient compliance
MR Conditional
- Combines long-term monitoring with the safety of MR Conditional labeling†
* AHA/ACCF – American Heart Association/American College of Cardiology
Foundation ESC – European Society of Cardiology
† Reveal DX has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. Please see the Reveal DX Clinician Manual in the Medtronic Manual Library for more details.
‡ Reliable = Sensitivity of 98%, PPV of 99%
References
- Krahn A, Klein G, Yee R, et al. Randomized Assessment of Syncope Trial. Conventional diagnostic testing versus a prolonged monitoring strategy. Circulation. 2001;104:46-51.
- Deharo J-C, Jego C, Lanteaume A, Djiane P. An implantable loop recorder study of highly symptomatic vasovagal patients. J Am Coll Cardiol. 2006;47:587-593.
- 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. 2001. Sept 11;104(11):1261-1267.
- Strickberger SA, Benson DW, Biaggioni I, et al. AHA/ACCF Scientific Statement on the Evaluation of Syncope: From the American Heart Association Councils and the American College of Cardiology Foundation: In collaboration with the Heart Rhythm Society. Circulation. January 17, 2006;113(2):316-327.
- 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.
- Farwell DJ, Freemantle N, Sulke N. The clinical impact of implantable loop recorders in patients with syncope. Eur Heart J. 2006 Feb;27(3):351-6.
- Krahn A, Klein G, 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.
Reveal XT ICM
Reveal® XT ICM captures the ECG you need to make informed decisions about your unexplained arrhythmia patients. It has an exclusive AF detection algorithm to monitor those patients who experience transient symptoms that may suggest a cardiac arrhythmia.1
Due to the complexity in diagnosing and monitoring these patients, it’s important to use the technology option that can provide clear information. With continuous ECG monitoring for up to 3 years, Reveal XT ICM overcomes the limitations commonly found with other testing and monitoring options.
Comprehensive Arrhythmia Monitoring With AF Detection
Automatically Classifies Rhythm Types
- Atrial tachyarrhythmia/atrial fibrillation (AT/AF)
- Ventricular tachyarrhythmia (VT)
- Fast ventricular tachyarrhythmia (FVT)
- Bradyarrhythmias
- Asystole
Includes an Exclusive AF Detection Algorithm
- May detect the presence of AT/AF, including asymptomatic episodes
- Monitors AT/AF burden to assess whether medical treatment is necessary or should be adjusted
- Monitors ventricular rhythm during atrial arrhythmias to assess the efficacy of rate control therapy
Provides Complete Diagnostics
- Cardiac Compass® Trends offers 14 months of rhythm data including:
- Accurate daily AF burden measurement2
- Ventricular rate during AT/AF
- Heart rate variability
- Average day and night rates
- AT/AF Summary provides duration and episode start time details
Allows Patient Activation
- Patient can tag symptoms with the Patient Assistant
- Handheld device alerts patient when to notify physician, based on physician-selected criteria
Ease of Use
Insertion
- Slim-shaped, leadless device simplifies insertion
- Reveal Vector Check confirms positioning
Follow-up
- Straightforward user interface allows for quick follow-ups
- Episode log allows data sorting and viewing by rhythm type
- ECG storage includes prioritization to streamline arrhythmia identification
Convenient Care
- Medtronic CareLink® Compatible
- Easy access to diagnostic data without an office visit – facilitates scheduling and treatment
- Data may be transmitted immediately after patient-tagged event or at scheduled intervals
MR Conditional
- Combines long-term monitoring with the safety of MR Conditional labeling3
References
- For more information regarding reimbursement, please contact your local Medtronic representative. In the United States, contractors have established Medicare coverage of Reveal XT ICM implants for patients diagnosed with unexplained fainting. Coverage to monitor patients with diagnoses other than unexplained syncope has not been addressed by Medicare contractors. Providers with questions should contact their contractor.
- Accurate = True daily burden > 10 minutes: AF burden in 92% of patients. True daily burden ≤ 10 minutes: Absence of AF appropriately detected in 96% of patients.
- Reveal XT ICM has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. Please see the Reveal XT Clinician Manual for more details.
