Medtronic Evera MRI ICD Clinical Study Meets Safety and Efficacy Endpoints

 
Late-Breaking Session at Heart Rhythm 2015 Features World's First Randomized Study of an MRI-Conditional Implantable Cardioverter Defibrillator Undergoing Full-Body MRI Scans; Study Simultaneously Published in JACC   

DUBLIN and BOSTON - Medtronic plc today announced clinical trial results for the Medtronic Evera MRI(TM) SureScan® implantable cardioverter defibrillator (ICD) following MRI scans. The study showed that full-body magnetic resonance imaging (MRI) scans do not affect the Evera MRI ICD's ability to detect potentially lethal heart rhythms and deliver life-saving therapy. Data were presented during a late-breaking clinical trial session at Heart Rhythm 2015, the Heart Rhythm Society's 36^th Annual Scientific Sessions and published simultaneously in the Journal of the American College of Cardiology (JACC).

The Evera MRI Clinical Trial, a multi-center, prospective, controlled clinical trial, is the first randomized study of an MRI-conditional ICD system that allows for full-body 1.5 Tesla (the field strength of the magnet) MRI scans. The Evera MRI ICD includes hardware and software design changes from previous generation devices that differentiate it from other ICDs and allow it to undergo full-body MRIs. The Evera MRI ICD System received CE (Conformité Européenne) Mark in March 2014. The Evera MRI ICD currently is limited to investigational use in the United States. 

Unlike other studies looking at MRI safety of ICDs, this robust study included: 

• MRI scans of the chest region, where the device is in close proximity to the MRI fields, as well as full-body scans 
• Enrollment of pacing-dependent patients, a high-risk group of patients who have either no underlying native heartbeat or an inadequate rate 
• Randomization, to help understand the true differences in the clinical outcomes post-MRI by comparing the results to a control group 

Currently, patients with ICDs are contraindicated from receiving MRI scans because of potential interactions between the MRI and device function, and the resulting risks to patients who rely on the life-saving therapies of their ICD. As such, there is a critical unmet need for patients suffering from irregular heart rhythms who require ICDs and who also have conditions that warrant MRI scans, which is the gold standard in soft-tissue imaging. As many as 64 percent of patients with an ICD will need an MRI within 10 years of receiving a device.

"The Evera MRI Clinical trial included a broad range of patients with varying medical conditions and co-morbidities who underwent full-body MRI scans to assess the performance of the Evera MRI ICD," said Michael R. Gold, M.D., Ph.D., chief of cardiology, Michael E Assey Professor of Medicine at the Medical University of South Carolina, and principal investigator in the study. "Our goal was to truly push the limits of the ICD, in ways that other studies have not, to ensure it is able to handle the stresses of MRI scans without impacting its ability to deliver potentially life-saving therapy."   

Source:  Medtronic plc