FDA Clears MRI-Safe Pacemaker
The Food and Drug Administration recently approved the first pacemaker that can safely be used in certain types of MRI exams. The device known as Revo-MRI is made by Medtronic, and it offers a switch that can be turned on in preparation for an MRI. About half of all patients currently with pacemakers may require an MRI but are advised against it because the magnetic fields interfere with the devices, according to the FDA in a recent press release. FDA’s approval of the Revo pacemaker represents an important step forward toward greater device innovation,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health. “Those patients who meet the parameters for the device will be able to maintain their critical cardiac therapy while benefiting from the precise diagnostic capability of an MRI.” The FDA based its approval on a single clinical trial of 484 patients, of which 464 were successfully implanted with the Revo device. An MRI was administered to 211 patients and none experienced MRI-related complications, based on the FDA release. As part of its approval the FDA is requiring training for cardiologists and radiologist.