Reveal XT Insertable Cardiac Monitor

MEDTRONIC, INC.

710 Medtronic Parkway
Minneapolis, Minnesota 55432
United States

(763) 514-4000
(800) 328-2518
(877) 526-7890

CONTINUOUS AF MONITORING FOR A FULL PICTURE OF A PATIENT’S RHYTHM

Why settle for a snapshot of your patient's rhythm when you can get the full picture? The Reveal^® XT ICM builds upon a 12-year history of Medtronic insertable cardiac monitors that have been used to benefit more than 180,000 patients worldwide.

Continuous monitoring with a Reveal XT ICM reliably identifies AF and correctly confirms the absence of AF. Reveal XT ICM is the only implantable continuous monitoring device with a dedicated AF detection algorithm and published clinical study that provides the information you need to make informed decisions.¹ The Reveal XT ICM detects AF in patients who experience transient symptoms or are at high risk for the presence of AF and provides information that may assist in AF patient management strategies.

For more information, please contact RevealXT@medtronic.com or call us at 800-328-2518.

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The Role of Reveal in AF Monitoring

PRODUCT FEATURES

Comprehensive, long-term cardiac monitor (three-year battery longevity) may provide automatic ECG recording of cardiac arrhythmias, including AF.
Slim size makes the monitor easy to implant.
Cardiac Compass® Summary Report includes rate/rhythm activity and AF burden.
Remote monitoring available through secure Medtronic CareLink® Network.
Customizable data fits your practice.

Important Safety Information

A patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.

REFERENCES

1. Hindricks G, Pokushalov E, Urban L, Taborsky M, Kuck KH, Lebedev D, Rieger G, Pürerfellner H; XPECT Trial Investigators. Performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation: Results of the XPECT trial. Circ Arrhythm Electrophysiol. 2010 Apr 1;3(2):141-7. Epub 2010 Feb 16.

Indications: 9529 Reveal^® XT Insertable Cardiac Monitor

The Reveal XT Insertable Cardiac Monitor 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.

9539 Reveal^® XT Patient Assistant

The Reveal XT Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor:

To verify whether the implanted device has detected a suspected arrhythmia or device related event.
To initiate recording of cardiac event data in the implanted device memory.

Contraindications: There are no known contraindications for the implant of the Reveal XT Insertable Cardiac Monitor. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.

Warnings/Precautions: 9529 Reveal XT Insertable Cardiac Monitor

Patients with the Reveal XT Insertable Cardiac Monitor should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing. MRI scans should be performed only in a specified MR environment under specified conditions as described in the device manual.

9539 Reveal XT Patient Assistant

Operation of the Model 9539 Patient Assistant 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, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

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.

Reveal, Cardiac Compass, and CareLink are registered trademarks of Medtronic, Inc.