Medtronic Viewpoint on MRI Safety

Medtronic believes the safety and effectiveness of a pacing system used in the MR environment must be proven through rigorous scientific testing and regulatory body review.

  • Implantable cardiac devices in MRI should be designed to be safe from the ground up
  • Caution should be taken before drawing conclusions from limited studies that have reported no adverse events
  • Several variables exist in an MRI that impact the patient:
    • lead type and length
    • anatomical position of implant
    • scan parameters

While limited studies have documented no MRI-related complications,
patient safety must be proven by:

Visual Algorithm

Safe by design, not by chance

Medtronic has spent more than 12 years conducting extensive research and rigorous testing to design a breakthrough pacing system both pacemaker and lead. The safety of the Revo MRI™ SureScan® Pacing System components for patients who need an MRI is based on exhaustive analysis:

  • Bench testing
  • Animal studies
  • Computer modeling
  • Clinical trial

The Revo MRI SureScan Pacing System is labeled as MR conditional and has received FDA approval for use with MRI

  • SureScan technology
  • Revo MRI SureScan pacemaker
  • Two CapSureFix® MRI SureScan Model 5086 leads

Physicians and their patients should accept nothing less than a pacing system that is safe by design and not by chance