Irish medical technology firm Medtronic has presented the results of its Evera MRI SureScan implantable cardioverter defibrillator (ICD) clinical trial.
According to the company, the trial demonstrated 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.
The Evera MRI clinical trial is a multi-center, prospective and randomized study of an MRI-conditional ICD system, which allowed for 1.5 Tesla MRI scans.
Medtronic cardiac and vascular group tachycardia business general manager and vice-president Dr Marshall Stanton said: "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 company enrolled 275 patients in the study at 42 centers across the globe, and they were randomized 2:1 to either undergo a series of MRI sequences of the cardiac, thoracic, cervical and head regions (MRI group), or a one-hour waiting period without MRI (control group).
Medtronic also included an additional subset of patients in the MRI group inducted with ventricular fibrillation, in a bid to characterize arrhythmia sensing, detection and therapy delivery.
The study reached the safety endpoint, showing 100% freedom from MRI-related complications in the MRI group and it also met both primary efficacy endpoints, noted Medtronic.
The Evera MRI ICD obtained CE mark approval in March 2014, and is currently limited to investigational use in the US.
Image: Medtronic operational headquarters, Minneapolis. Photo: courtesy of Medtronic, Inc.