Backed by Clinical Evidence

Safety is confirmed only through rigorous scientific testing, clinical studies, and regulatory review

Only a SureScan® Pacing System satisfies this degree of testing and has FDA approval. It is the first pacing systems designed, tested and approved for MRI use.


  • Extensive analysis conducted to evaluate safety using worst-case scenarious:
    • Bench testing
    • Animal studies
    • Computer modeling
    • Evaluation in a controlled clinical trial

Revo MRI: A clinical trial confirms the safety of the Revo MRI SureScan Pacing System for patients who need an MRI1


Study Design

  • Multicenter, randomized, controlled clinical trial1
  • 464 patients received a Revo MRI SureScan Pacing System
  • Randomized to elective MRI (MRI Group) or no MRI (Control Group)
  • Follow-up: 11.2 5.2 months (mean)
  • Pacing systems were interrogated immediately after implant and at regular intervals
  • MR imaging intended to represent commonly used, clinically relevant scans

Key Results

  • The MRI safety and effectiveness of the Revo MRI SureScan Pacing System was confirmed in patients undergoing MRIs
  • Achieved high success rates of clinically equivalent thresholds and sensing amplitudes when compared to control group
  • 100% of patients were free of MRI-related complications (n=211, P < 0.001)
  • No sustained atrial or ventricular arrhythmias, no asystole, no pacemaker output inhibition, and no electrical resets in the group receiving MRI (n=211)
  • Secondary objectives evaluating pacing systemrelated complications and impedance favorably achieved

Advisa MRI: Advisa MRI SureScan system is safe and effective in the MRI environment.


Study Design

  • Prospective, randomized controlled, multi-center/263 patients
  • Designed to confirm safety and effectiveness of the Advisa MRI SureScan Pacing System

Results

  • No MRI related complications
  • Similar pacing capture thresholds changes between the MRI and control groups


Advisa Clinical Graph


For further information on the Revo MRI SureScan Pacing System clinical summary results, visit www.medtronic.com/mri.