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|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 - May 14, 2015 - Medtronic plc (NYSE: MDT) 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 36th 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:
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.1
"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."
About the Evera MRI Clinical Trial
The study met the safety endpoint, demonstrating 100 percent freedom from MRI-related complications (p<0.0001) in the MRI group. The study also met both primary efficacy endpoints. The percentage of MRI and control patients who experienced changes in the electrical performance of their ICD system from pre-MRI/waiting period to one month later was similar:
"Access to MRI scans is vital to ICD patients," said Marshall Stanton, M.D., vice president and general manager, Tachycardia business, which is part of the Cardiac and Vascular Group at Medtronic. "Medtronic has long been the leader in developing implantable devices that are approved for use in an MRI environment, and we look forward to being able to provide an MR-conditional ICD to patients."
The Evera MRI ICD is built off of the Evera family of ICDs and includes the following key features and benefits:
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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1 Nazarian S, Reynolds M, Ryan M, et al. Estimating the Likelihood of MRI in Patients After ICD Implanation: A 10-Year Prediction Model. J Am Coll Cardiol. 2015;65(10S)
2 Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file.