Getting MRI scans while wearing an electronic cardiac implant seemed like a pipe dream only a few years ago, but lately new pacemakers and defibrillators have been developed that have conditional approvals to be used during magnetic resonance imaging. While the big names in implants all have MRI compatible devices, they all had limitations regarding which parts of the body were safe to scan (usually not the chest) and required technicians to specially prepare patients with implants before imaging.
Now Medtronic has announced that its Advisa DR MRI and Revo MRI SureScan pacemakers received FDA approval to be MRI compatible without any limitations on the positioning of the patient. The approval was based on the agency’s review of both clinical data, as well as computer modeled simulations of chest scans. This is a pretty big deal for patients that will be getting these implants, as it allows their doctors to keep using MRI for diagnostic purposes, something that such patients tend to need more than the general population.
Flashbacks: RestoreSensor SureScan MRI Neurostimulator FDA Approved for Full Body MRI; Revo MRI SureScan, First MR-Conditional Pacemaker, Approved in U.S.; Medtronic’s Advisa MRI SureScan Pacemaker Finally Cleared in U.S.; Medtronic’s New MRI Compatible Pacemaker Gets CE Mark