SureScan Safety Data MRI Access
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)|
Evera MRI™ SureScan system is safe and effective in the MRI environment when MR conditions for use are met.
Advisa MRI™ SureScan system is safe and effective in the MRI environment when MR conditions for use are met.
Ramza B, et al. Are There Cumulative Effects of Multiple MRI on MR-conditional Pacemakers? Presented at HRS, May 2014.
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.
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.
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.
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.
For further information on the Revo MRI SureScan Pacing System clinical summary results, visit www.medtronic.com/mri.