Device manufacturer Medtronic has received U.S. Food and Drug Administration (FDA) approval for its MRI-conditional cardiac resynchronization therapy defibrillators (CRT-Ds).
The defibrillators, used to treat heart failure and reduce the risk of sudden cardiac arrest, add to Medtronic's portfolio of MR-conditional cardiac devices, which also include pacemakers and implantable cardioverter defibrillators (ICDs).
Previously, patients with CRT-Ds were contraindicated from undergoing MRI due to the potentially harmful interaction between the scanner and the device. Now these patients can undergo an MRI if the scans are needed.
The approval applies to Medtronic's Amplia MRI Quad CRT-D SureScan and Compia MRI Quad CRT-D SureScan systems, which are approved for MRI scans without positioning restrictions and on any part of the body. Both systems will be available in the coming months, Medtronic said.
