|Evera SureDR (dual chamber) SureScan implantable ICD|
MRI-conditional pacemakers that allow patients implanted with pacemakers undergo MRI scans without worrying about device interference have been around for a while.
Now, Medtronic is touting the fact that the FDA has approved the first ICD that allow patients to undergo full body MRI scans. On Monday, the Irish medtech company announced that the device called Evera MRI SureScan system has won FDA approval. Previously, patients with ICDs were prevented from undergoing MRI scans because of fears that the MRI device and the implanted ICD would interact.
The device is approved for MRI scans on any part of the body without any positioning restrictions. The newly approved system includes the Evera MRI ICD and Sprint Quattro Secure MRI SureScan DF4 leads, which need to be used together to be considered MR-conditional.
The availability of this technology is a milestone for patients because "53-64% of ICD patients will require an MRI over a ten-year time horizon, highlighting the importance of MRI conditional ICDs for this patient population," according to a study published in the Journal of the American College of Cardiology in March.
"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," said Dr. Michael R. Gold, chief of cardiology, Michael E Assey Professor of Medicine at the Medical University of South Carolina, and principal investigator in the Evera MRI Clinical Trial, in the Medtronic news release. "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."
The FDA approval of the Evera MRI ICD system was based on data from the Evera MRI Clinical Trial, a multicenter, prospective, randomized, controlled clinical trial that enrolled 275 patients at 42 centers globally.
[Photo Credit: Courtesy of Medtronic]
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