FDA Approves First MRI-Safe CRT Defibrillators

The U.S. Food and Drug Administration (FDA) approved on Feb. 5 Metronic's Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan devices for the treatment of heart failure (HF). Both cardiac resynchronization therapy defibrillators (CRT-Ds) feature lead wires that make the devices magnetic resonance imaging (MRI)-conditional, allowing HF patients to receive MRI scans on any part of the body without positioning restrictions.

According to Medtronic, "Until now, CRT-Ds have been contraindicated by the FDA to undergo MRI scans because of the potential interaction between the MRI and the device, resulting in risk to patients…The Amplia MRI and Compia MRI CRT-Ds with quadripolar technology offer physicians multiple options to help treat HF by optimizing CRT delivery, which may improve patient outcomes." Read more.

Clinical Topics: Arrhythmias and Clinical EP, Heart Failure and Cardiomyopathies, Noninvasive Imaging, Implantable Devices, SCD/Ventricular Arrhythmias, Acute Heart Failure, Magnetic Resonance Imaging

Keywords: Cardiac Resynchronization Therapy, Defibrillators, Implantable, Heart Failure, Magnetic Resonance Imaging, United States Food and Drug Administration


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