EVERA MRI

EVERA MRI is the world’s first full body MRI safe defibrillator.  This trial enrolled 275 patients at 42 centers around the world and the very first implant of the study took place right here at our hospital on April 22, 2014.  (Link to press release  http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1920630    )   Patients were enrolled with the MRI safe defibrillator and randomized 2:1 to either undergo an elective MRI to test the system performance or sit for a 1 hour waiting period.  A sub-group of the MRI subjects had their heart put into ventricular fibrillation (a very fast heart rate) in order to test the defibrillator’s ability to sense & detect this problem and deliver the proper therapy.  The ability to allow patients with this device to be able to have an MRI is very important and it is estimated that up to 64% of patients with an ICD will need an MRI within 10 years of receiving a device.

The FDA (Food & Drug Administration) approved this device for public use on September 14, 2015.