Pacing Systems Approved for Full Body MRI Scans Without Positioning Restrictions

The first pacing systems in the United States that have been approved by the US Food and Drug Administration (FDA) for use with magnetic resonance imaging (MRI) are now approved for MRI scans positioned on any part of the body.

Patients implanted with the Medtronic, Inc. (Minneapolis, MN, USA), Advisa DR MRI, or Revo MRI SureScan pacing systems now can have MRI scans without positioning limitations, including the chest region, which previously had been restricted.

“This approval allows for a more streamlined MRI scanning process and makes scanning the chest easier and more accessible for patients with pacemakers,” said Pat Mackin, president of the cardiac rhythm disease management business and senior vice president at Medtronic. “Because MRI is the standard of care for soft tissue imaging and is a critical component for early detection, diagnosis, and treatment, this FDA approval will help more patients with SureScan pacemakers receive the MRI scans they need.”

Patients in the United States, until the introduction of Medtronic’s SureScan pacemakers, had been contraindicated from receiving MRI scans due to potential interactions between the MRI and device function. According to recent studies, up to 75% of patients worldwide with implanted cardiac devices are estimated to need an MRI scan during the lifetime of their devices.
The recent approval was made after the FDA review of computer modeling and clinical data validating that MRI chest-positioned scans are safe for patients. The first MR-Conditional pacemaker available in the United States, the Medtronic Revo MRI, was FDA-approved in February 2011, and the second-generation Advisa MRI was approved by the FDA in January 2013.

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