FDA OK's Pacemaker that's safe in MRI

This could be huge news for the thousands of pacemaker wearers - like Mr. Maven - who have to avoid getting potentially lifesaving MRI imaging because of their implanted pacemakers.

-maven

FDA approves 1st pacemaker designed to work safely during some MRI exams

The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats. MRIs use a powerful magnetic field, radio frequency pulses and an internal computer to produce detailed images of organs, soft tissues, bone, and other internal body structures not available with other imaging methods.

About half of all patients with pacemakers may require an MRI, but are advised not to have one because an MRI’s  magnetic and radiofrequency fields can disrupt the pacemaker’s setting or cause wires to overheat, resulting in unintended heart stimulation, device electrical failure, or tissue damage.
 
The Revo MRI SureScan Pacing System includes a function that is turned on before a scan to prepare patients for the MRI. The pacemaker’s use in MRIs is limited to certain patients, certain parts of the body, and certain scanning parameters. The FDA also is requiring training for cardiologists and radiologists who use the system.

“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 reviewed results from one clinical trial of 484 patients. Of those, 464 were successfully implanted with the device and then randomized to receive or not receive an MRI. None of the 211 who underwent an MRI experienced an MRI-related complication. The clinical results confirmed earlier data from animal studies, computational modeling, and other nonclinical research.

Revo is manufactured by Medtronic Inc. of Mounds View, Minn.



Is Breast MRI right for me?

I was happy to participate in late clinical studies to determine the efficacy of breast MRI at The University of Texas, M. D. Anderson Cancer Center back in 2002 while I was undergoing treatment for my own Stage IIIa breast cancer. It’s one more important tool that can and should be available to better and more accurately diagnose breast cancer.

Myth #3: MRI is better than mammography

FALSE. What do we really want from MRI or mammography? To save lives. Unfortunately, MRI has not been shown to do that.

MRI does not work better than mammography—it just works differently. Evidence does exist that mammography may save lives. Even though MRI does find more cancer than mammography, there is no evidence that doing so saves lives.

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Breast Cancer: Is breast MRI right for me?