EU gives nod to St. Jude's MRI pacemaker

St. Jude Medical’s Accent MRI pacemaker and Tendril MRI lead have been granted a CE mark. The systems are approved as MR-Conditional and allow patients to undergo full-body MRI scans.

St. Paul, Minn.-based St. Jude said the technology uses an MRI Activator device that provides an option for programming the device to the appropriate MRI mode during the scan. The software does not require a programmer and can be activated with a single button on the handheld device during the scan. The device parameters are pre-selected by the patient’s physicians and stored into the MRI pacemaker and then Activator can be used to program the device back to the original settings after the patient undergoes the scan.

In addition, St. Jude said the lead also houses the Optim lead insulation, a silicone-polyurethane co-polymer material for cardiac use.

The Accent MRI pacemaker features InvisiLink telemetry that provides a connection between the device and the clinician, which is used during follow-up appointments either at the office or via remote home monitoring. Lastly, the Accent MRI pacemaker features the AutoCapture Pacing System to measure heart reaction to pacing beat-by-beat.

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