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.

2 Responses to “FDA Approves First Pacemaker Designed For Use with MRI”

  1. Rohan Parikh, M.B.B.S. says:


  2. I am writing about the new wave of MRI-compatible pacemakers and would like to know what cardiologists and electrophysiologists expect. Will these eventually replace all other pacemakers? Are companies at work now trying to create CRT and CRT/ICD units that can be used in an MRI?

    For now, will American physicians use the first generation pacemaker in select patients who may need an MRI of the brain or other area but wait for the second generation coming from several companies for most patients since the first generation device won’t allow chest MRIs? Of course the dilemma is if a patient needs a pacemaker now, you can’t wait for the better one.

    And what about all the patients who already have an older model pacemaker? In order to get one of these MRI compatible models, you would have to remove the existing pacemaker, leads and all. Because of the risk, is that something you would only do in a patient who badly needs an MRI for another medical condition?

    If you answer these questions on this site, please do so allowing me to quote you in my story or please feel free to answer me by e-mail at knudson@erols.com. I would greatly appreciate hearing from you.