Vårdpersonal

Evera MRI XT DR and VR

ICD Defibrillators

Clinical Studies & Guidelines

Evera MRI Clinical Trial1

The Evera MRI SureScan system is safe and effective in the MRI environment when labeling conditions are met.

  • Prospective, randomized, controlled, multi-center with 275 patients
  • Designed to confirm safety and effectiveness of Evera MRI SureScan ICD System

Results

  • 100% Freedom from MRI-related complications within 30 days post-MRI; no sustained tachyarrhythmias requiring immediate treatment during MRI. (p<0.0001)
  • 100% of MRI subjects did not experience a greater than 0.5 V increase in ventricular pacing capture threshold; Control group 98.2%. (non-inferiority p<0.0001)
  • 99.3% of MRI subjects did not experience a greater than 50% decrease in R-wave amplitude; Control group 98.8%. (non-inferiority p=0.0001)
  • No impact to detection and therapy delivery was observed in 20 induced and 14 spontaneous sustained VT/VF episodes post-MRI.

 

References

1

Gold MR, et al.J Am Coll Cardio. 2015;65(24):2581-2588.