FDA OKs Abbott’s pacemaker for use in MRIs

The Food and Drug Administration gave Abbott approval to label its Assurity MRI pacemaker and the Tendril MRI pacing lead as MRI-compatible.

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Patients implanted with the devices will be able to undergo full body MRI scans.

During an MRI scan, Abbott’s MRI Activator device automatically triggers pre-programmed MRI settings for the pacemaker, which eliminates the need for conventional pre- and post-scan pacemaker reprogramming.

“The ability to choose a device to best address a patient’s cardiac condition no longer has a tradeoff with MRI compatibility. It’s the best of both worlds,” said David Sandler, MD, director of electrophysiology at the Oklahoma Heart Institute in Tulsa, Okla.

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