February 8th, 2011
FDA Approves First Pacemaker Designed For Use with MRI
The FDA has approved Medtronic’s Revo MRI SureScan Pacing System, the first pacemaker designed for safe use during MRI exams. Here is Medtronic’s description in a press release of how the pacemaker differs from traditional pacemakers:
“The pacemaker system includes hardware modifications to the device and leads that are designed to reduce or eliminate several hazards produced by the MRI environment. In addition, since MRI scanners may cause other current pacemakers to misinterpret MRI-generated electrical noise and withhold pacing therapy or deliver unnecessary pacing therapy, this new pacemaker includes a proprietary SureScan feature that sets the device into an appropriate mode for the MRI environment.”
“FDA’s approval of the Revo pacemaker represents an important step forward toward greater device innovation,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, in an FDA press release. “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.”
According to Medtronic, every year about 200,000 pacemaker patients in the U.S. are forced to skip a medically indicated MRI exam.