Healthcare Professionals

Reveal XT

Insertable Cardiac Monitor

  • Reveal XT ICM Device

Product Overview

Reveal™ XT Insertable Cardiac Monitor (ICM) captures the ECG you need to make informed decisions about your syncope patients and those who experience transient symptoms that may suggest a cardiac arrhythmia.

Reveal XT ICM Provides

  • 3-year longevity for long-term monitoring1
  • MR conditional labeling for safe patient management‡
  • Medtronic CareLink™ Network compatibility for remote monitoring

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

INDICATIONS

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.

PRODUCT DETAILS

Reveal XT Implant Location Image

IMPLANT PROCEDURE

  • Reveal Vector Check establishes the best implant positioning
  • The Reveal XT ICM is placed under the skin in the upper chest area
  • Slim-shaped, leadless device simplifies insertion

The recommended implant zones are from the left parasternal area extending to the mid-clavicular line between the first intercostal space and the fourth rib (choose a site as near to the sternum as possible). The lower chest V3 area, between the fourth and fifth rib, is an alternative implant site. The exact location may vary from this diagram due to the patient’s anatomy.

During the brief procedure, the area is numbed with local anesthesia, a small incision is made, and the monitor is inserted.

Remote Monitoring 

Medtronic CareLink Network Compatible

  • Easy access to diagnostic data without an in-office clinic visit – optimizes scheduling and treatment
  • Data may be transmitted immediately after patient-marked event or at scheduled intervals

MRI Conditions for Use

The Reveal XT can be safely scanned in patients under the following conditions:

  • Patients must wait 6 weeks post-insertion before having an MRI scan.
  • Closed bore, cylindrical magnet with static magnetic field must be 1.5 T or 3.0 T.
  • Whole body gradient systems with gradient slew rate specification must be ≤200 T/m/s.
  • Whole body Specific Absorption Rate (SAR) as reported by the MRI equipment must be ≤2.0 W/kg; head SAR as reported by the MRI equipment must be ≤3.2 W/kg.
  • The uninterrupted duration of active scanning (when radio frequency (RF) and gradients are on) over the chest during MRI must not exceed 30 min.
  • If additional chest scans beyond 30 min are necessary, a waiting period of at least 10 min is required.

NOTE: To assure Reveal XT data is preserved, we recommend an in-office interrogation of the device using the 2090 programmer before completing the MRI. However, it is not necessary to delay the procedure if the interrogation was not performed.

MODEL SPECS

Reveal XT 9529 Specifications

DESCRIPTION Specifications

Volume

9 cc

Dimensions

95 mm x 62 mm x 8 mm

Mass

15 g

Distance between electrodes

40 mm

MRI Compatibility

MR Conditional at 1.5 and 3.0 T with 6-week post-insertion waiting period required

Battery Longevity

Projected 3 Years

‡Reveal XT ICM has been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. Please note that patients must wait 6 weeks post-insertion before having an MRI scan. Please see the Reveal XT ICM Clinician Manual or MRI Checklist for more details.

Reference

1

Reference the Reveal XT ICM Clinician Manual for usage parameters.

IMPORTANT INFORMATION ON INDICATIONS, SAFETY AND WARNINGS

For listing of Indications, Contraindications, Warnings, Precautions, and Potential Adverse Events, please refer to the Instructions For Use .