FDA Approves MRI-Safe ICD
The U.S. Food and Drug Administration (FDA) has approved Medtronic’s Evera MRI SureScan implantable cardioverter defibrillator (ICD) as ‘MR conditional,’ allowing patients with the ICD to safely receive magnetic resonance imaging (MRI) scans. This device is the first of its kind and also includes MRI-safe leads.
The approval is based on the results of the Evera MRI study, presented at Heart Rhythm 2015 in Boston, which showed “no evidence of causing any adverse effect on the electrical performance or the ability to treat ventricular arrhythmias.” According to Medtronic, the new ICD will be available in late September.
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