New Pacemaker Safe to Use With MRI

The U.S. Food and Drug Administration (FDA) cleared the first pacemaker in the United States specifically designed for use in an magnetic resonance imaging (MRI) environment. The Medtronic Revo MRI SureScan pacing system provides pacemaker patients with access to MRI detection of serious medical conditions such as stroke, cancer, and a wide variety of important neurologic and orthopedic conditions.

Prior to the introduction of Revo MRI, pacemaker patients could face serious complications if they were exposed to the powerful magnetic fields generated by MRI machines. Complications include interference with pacemaker operation, damage to system components, or a change in pacing capture threshold, which is the minimum amount of current required to evoke a cardiac contraction. Revo MRI, when programmed into SureScan mode prior to an MRI scan, is designed to be safe for the MRI environment when used per the specified MR conditions for use. Revo MRI is considered MR-conditional, a term used to indicate that a device may be used in the MRI environment under certain conditions, such as a particular type of MRI scanner and scanner settings.

The Revo MRI pacing system must consist solely of a Medtronic Revo MRI SureScan device and two CapSureFix MRI SureScan Model 5086MRI leads. Prior to scanning a patient, refer to the Revo MRI conditions for use located in the device manuals.

For more information: www.medtronic.com/patient/revomri