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FDA approves Medtronic pacemaker for MRI... without scanning restrictions.

Posted by: James Walsh under Minnesota innovation, Minnesota technology Updated: January 22, 2014 - 10:07 AM

Medtronic Inc. on Thursday announced that its SureScan pacing systems – the first and only pacing systems in the United States that have been approved by the U.S. Food and Drug Administration (FDA) for use with magnetic resonance imaging (MRI) – are now approved for MRI scans positioned on any region of the body. Previously, patients implanted with the devices could not have MRI scans of the chest area.

“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.”

Generally, patients with pacemakers do not receive MRI scans because of the potential that the MRI machine could interfere with the device.

But Medtronic says that up to 75 percent of patients worldwide with implanted cardiac devices will need an MRI scan during the lifetime of their devices.

The FDA approved the first MRI compatible pacemaker available in the U.S. – Medtronic’s Revo MRI, in February 2011. A second generation pacemaker, the Advisa MRI, was approved by the FDA in January 2013.

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