MR-Conditional Products

Insertable Cardiac Monitor

Magnetic Resonance Imaging (MRI) and Reveal ICMs

Reveal Insertable Cardiac Monitor

Reveal^® Insertable Cardiac Monitors (ICMs) are MR conditional,* allowing the ability to safely provide MR testing. The device includes two surface electrodes to continuously monitor a patient's subcutaneous ECG. The device contains no lead wires or large loops of electrically conductive material.

Magnetic and radio frequency (RF) fields produced by MRI may adversely affect the data being stored by Reveal ICMs. Also, since ICMs contain ferromagnetic components, the strong magnetic field of the MRI system may apply a mechanical force on the ICMs. The patient may be able to feel this magnetic force on the ICMs. While this does not represent a safety hazard, the patient must be made aware of this possibility to avoid undue patient concern.

Although Reveal ICMs are considered conditionally safe for use in the MRI environment when used under the specified conditions, other implanted devices or the patient’s individual medical condition might have an impact on safety and might require additional examination. If applicable, user manuals for the other implanted devices, including abandoned leads, should be consulted before conducting the MRI scan.

Patients with a Reveal ICM that has been implanted for less than 6 weeks are contraindicated for an MRI procedure. The 6-week post-implant waiting period allows sufficient time for implant pocket and wound healing and minimizes the effects of “tugging” on the device caused by the magnetic fields.

Patients with a Reveal ICM implanted in sites other than the subcutaneous region of the chest are contraindicated for an MRI procedure.

* Reveal ICMs have been demonstrated to pose no known hazards in a specified MR environment with specified conditions of use. Please see Reveal DX and Reveal XT ICMs clinician manuals for more details.
 

Revo MRI™ Pacing System
Engineered with SureScan® technology

Now, for the first time, you can implant a state-of-the-art pacing system to provide proven cardiac care and MRI access when your patients need it.

FDA-Approved for MRI use, the Revo MRI^™ Pacing System engineered with SureScan^® Technology – is the first pacing system designed to be used safely with MRI when used according to the specified conditions for use.

Given that 85% of all pacemaker patients have one or more comorbidities,¹ facilitating comprehensive multispecialty care is important in today's environment. MRI is the gold standard diagnostic tool for Neurologists, Oncologists and Orthopedic Surgeons. Now patients get proven cardiac care with MRI Access.

The Revo MRI SureScan^® pacing system has completed clinical evaluation, regulatory review and FDA approval and is safe for use when used according to the MRI conditions for use as defined in the SureScan manual.