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FDA OKs first pacemaker for use during MRI
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The FDA has approved the first pacemaker system that can be used in an MRI environment, according to a press release.
Medtronic’s RevoMRI SureScan pacemaker system includes a function that is switched on prior to MRI scanning. The device was approved after review of a 484-patient study in which 464 patients were successfully implanted with the device and randomly assigned to receive an MRI. According to the agency, there were no MRI-related complications in the 211 patients who received MRIs.
“FDA’s approval of the Revo pacemaker represents an important step forward toward greater device innovation,” Jeffrey Shuren, MD, director of the Center for Devices and Radiological Health, said in a press release. “Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefitting from the precise diagnostic capability of an MRI.”
The FDA said it would require the implementation of training for the cardiologists and radiologists who would be using the pacemaker system. The agency also noted that the device is considered MR-conditional, meaning that the device may be used in the MRI environment only under certain conditions, such as with a particular type of MRI scanner, certain parts of the body and with specific scanner settings.
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