FDA approves MRI-safe pacemaker

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Medtronic has received FDA approval for its Revo MRI SureScan pacing system, designed for use in an MRI environment and approved as MR-Conditional.

Revo MRI, when programmed into SureScan mode prior to an MRI scan, is designed to be safe for the MRI environment when used per the specified MR Conditions for Use. Revo MRI is considered MR-Conditional, a term used to indicate that a device may be used in the MRI environment under certain conditions, such as a particular type of MRI scanner and scanner settings, explained Minneapolis-based Medtronic.

Each year, an estimated 200,000 pacemaker patients in the U.S. have to forego MRI scans, which are contraindicated for patients with implanted pacemakers due to potential adverse events, according to the company. Complications to exposure could include interference with pacemaker operation, damage to system components or a change in pacing capture threshold.

Shipments of Revo MRI will begin immediately.