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FDA clears Medtronic Revo MRI SureScan pacing system

Medtronic has received the US Food and Drug Administration (FDA) approval for Revo MRI SureScan pacing system, designed for use in an Magnetic Resonance Imaging (MRI) environment.

Medtronic claims Revo MRI is the first and only pacemaker in the US and its shipments will begin immediately.

Earlier, before the introduction of Revo MRI, if pacemaker patients were exposed to the magnetic fields generated by MRI machines, they used to face complications like interference with pacemaker operation, damage to system components, or a change in pacing capture threshold, which is the minimum amount of current required to evoke a cardiac contraction.

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.