Medtronic has received the first FDA-approval for an implantable cardioverter defibrillator (ICD) system for use with magnetic resonance imaging (MRI) scans
Medtronic's Evera MRI(TM) SureScan ICD Systems
Sudden cardiac arrest (SCA) is a sudden, abrupt loss of heart function that can result in death if not treated within minutes with an electrical cardioverter shock delivered by an ICD.
Until now, patients with ICD systems have been FDA-advised not to receive MRI scans because of potential interactions between the MRI and device function.
The Medtronic Evera MRI(TM) SureScan ICD System is approved for MRI scans on any part of the body without positioning restrictions.
The newly approved system includes the Evera MRI ICD and Sprint Quattro Secure MRI SureScan DF4 leads, which must be used together to be considered MR-conditional.
The FDA approval of the Evera MRI ICD system was based on safety and efficacy data from the Evera MRI clinical trial which has been published in the Journal of the American College of Cardiology (JACC).
The data from the trial demonstrated that the Evera MRI ICD system is safe and effective and that full-body MRI scans did not affect its ability to deliver life-saving therapy.
Michael Gold, chief of cardiology and principal investigator in the Evera MRI clinical trial, said: "Patients at risk for sudden cardiac arrest have long relied on ICDs to monitor their hearts, detect dangerous arrhythmias and deliver the life-saving therapy needed to survive.
"Many of these patients also need access to MRIs, so the approval of an ICD that can be used in an MRI environment is crucial, and can help provide patients with the peace of mind that they are receiving the best care available."