FDA clears Medtronic's cardiac devices for MRI use

The U.S. Food and Drug Administration (FDA) has cleared device manufacturer Medtronic's cardiac devices for MRI use.

Patients with SureScan MR-conditional pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy defibrillators can now undergo both 1.5- and 3-tesla MRI scans.

U.S. patients with the following devices are now eligible for MRI, Medtronic said:

  • Advisa MRI pacemakers and Micra transcatheter pacemaker
  • Amplia MRI and Compia MRI cardiac resynchronization therapy defibrillators
  • Evera MRI and Visia AF MRI DF-1 and DF4 implantable cardioverter defibrillators
  • Reveal Linq insertable cardiac monitors
  • SureScan pacing, defibrillation, and left-heart leads

Each year, approximately 12% to 16% of patients with cardiac devices have a condition in which MRI would normally be prescribed, but less than 1% of these patients receive scans because of device or lead restrictions, Medtronic said.

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