MRI-Compatible Cardiac Pacing System (REVO) for Patients Who May Require Future MRI

Electronic implantable cardiac pacemakers have been an established therapy for several cardiac arrhythmias since the technology was introduced decades ago. At the same time, utilization of various medical imaging exams, including MRI, has increased significantly in recent years. However, MRI scans are typically contraindicated in patients with electronic cardiac implants because the electromagnetic fields produced during MRI can cause device malfunctions and heating of the electrodes, potentially resulting in fatal harm to patients.

Medtronic, Inc. (Minneapolis, MN, USA) developed an MRI-compatible implantable cardiac pacemaker that allows patients to safely undergo MRI scans under specific conditions. The Medtronic Revo MRI Sure Scan pacing system (formerly known as the EnRhythm pacing system) is designed to deliver the same type of cardiac pacing therapy as conventional dual-chamber cardiac pacemakers for similar indications. The Revo system includes the Revo MRI SureScan IPG (implantable pulse generator) and two CapSureFix MRI SureScan electrode leads.1,2

The U.S. Food and Drug Administration (FDA) approved Medtronic's premarket approval application for the Revo MRI SureScan pacing system on February 8, 2011. The device is approved as MR-Conditional, indicating use of the Revo pacemaker is permissible in an...