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SureScan Safety Data MRI Access

Designed for Safe Use with MRI when MR Conditions for Use are Met

Powerful fields produced during MRI have the potential to induce hazardous effects on patients with traditional implantable cardiac devices.

Potential Hazard Device (Impact) Field (Static/Gradient/RF)

Lead Heating 
The conductive pacing and defibrillation leads act as an antenna, picking up radio frequency energy. A portion of this energy is dissipated as heat in the cardiac tissue near the tip electrode.

Tissue damage may affect pacing or defibrillation therapy.

RF

Unintended Cardiac Stimulation 
The gradient and radio frequency fields will induce voltages in pacing and defibrillation leads that will be applied to the lead electrodes. If these voltage pulses are large enough, they may directly stimulate the heart.

May lead to a single intermittent stimulation or sustained tachycardia.

Gradient, RF

Device Interactions
The gradient, radio frequency, and static fields may adversely affect the electrical operation of the CRT, ICD, or pacemaker system if its operation is not protected from the effects of those fields.

CRT, ICD, or pacemaker malfunction or failure may affect pacing or defibrillation therapy.

Static, Gradient, RF

SureScan Technology – Supported by extensive evidence & Experience

3,739 SureScan Patients Studied

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Evera MRI SureScan system Safety Data

Evera MRI™ SureScan system is safe and effective in the MRI environment when MR conditions for use are met. 

Study Design

  • Multicenter, randomized, clinical trial2
  • Designed to confirm safety and effectiveness of the Evera MRI™ SureScan™ ICD System
  • Patients in MRI group underwent a series of 10 chest and head scan sequences designed to maximize radiofrequency exposure up to 2W/kg SAR
  • Patients in control group waited for one hour, no MRI scan conducted
  • Post testing included: Pacing threshold and sensing test and observation for episodes at one week and one month post-MRI/waiting visit
  • At one month post-scan, a subset of MRI patients underwent induction testing to confirm VF detection/ therapy delivery after exposure to MRI (n=20)

Key Results

  • SAFETY: 100% Freedom from MRI-related complications within 30 days post-MRI; no sustained tachyarrhythmias requiring immediate treatment during MRI (p<0.0001)
  • EFFICACY: 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)
  • EFFICACY: 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
pdf Managing Metallic Artifacts in MRI (.pdf)

  • Diagnostic quality cardiac MRI scans are obtainable with the Evera MRI ICD system
  • Refer to this resource document "Managing Metallic Artifacts in MRI" for information on modifying the sequences to reduce metal artifact
  • For example, in the Evera MRI ICD clinical study, Fast Gradient Echo (FGE) produced better image quality and smaller artifacts for cardiac MRI than Steady State Free Precession (SSFP)

Advisa DR MRI SureScan System Safety Data

EnRhythm MRI SureScan Pacing System safety data

1

Ramza B, et al. Are There Cumulative Effects of Multiple MRI on MR-conditional Pacemakers? Presented at HRS, May 2014.

2

Gold MR, Sommer T, Schwitter J, et al. Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator: Primary Results of a Randomized Study. J Am Coll Cardiol. June 23, 2015; 65(24):2581-2588.

3

Shenthar J, Milasinovic G, Al Fagih A, et al. MRI scanning in patients with new and existing CapSureFix Novus 5076 pacemaker leads: randomized trial results. Heart Rhythm. April 2015;12(4):759-765.

4

Gimbel JR, Bello D, Schmitt M, et al. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. May 2013;10(5):685-691.

5

Wilkoff BL, Bello D, Taborsky M, et al. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm. January 2011;8(1):65-73.