FDA panel gives unanimous thumbs up to Medtronics MRI pacing system

The FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted unanimously in favor of approving with conditions Medtronic’s Revo MRI SureScan pacing system designed as MR conditional, or safe for use in MRI systems under specified conditions.

In the U.S., MRI procedures are not recommended for patients who currently have implanted pacemakers. If approved, Revo MRI has the potential to be the first FDA-approved pacing system designed for use in the MRI setting.

The FDA’s Circulatory System Devices Panel, which met March 19, recommended Revo MRI for approval with conditions related to the planned post-market study, healthcare professional training and labeling to reflect MRI scans are to be conducted with the Revo MRI SureScan pacing system.

The FDA considers the panel’s recommendation in its review of Revo MRI; however, it is not bound by its Advisory Committee’s recommendations.

The panel reviewed safety and effectiveness data from a prospective, randomized multicenter trial at 42 centers globally, featuring 464 implanted patients. Major inclusion criteria included standard Class I or II dual-chamber pacemaker indication, which allowed for pacemaker-dependent patients. Patients were excluded if they had previously implanted medical devices or abandoned leads. Patients were randomized at implant to either receive an MRI or not to receive an MRI.