FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee has approved with conditions the Revo MRI SureScan pacing system designed as MR Conditional, or safe for use in Magnetic Resonance Imaging (MRI) systems under specified conditions.
The conditions for FDA approval include planned post-market study, health care professional training, and labeling to reflect MRI scans to be conducted with the Revo MRI SureScan Pacing System. The FDA will consider the panel’s recommendation in its review of Revo MRI; however, it is not bound by its Advisory Committee’s recommendations.
The FDA panel has reviewed safety and effectiveness data from a prospective, randomized multi-center trial at 42 centers around the world featuring 464 implanted patients. Major inclusion criteria was 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.
The primary endpoints evaluated were safety and effectiveness of the Revo MRI pacing system in the MRI environment. For safety, the MRI group was evaluated for MRI procedure-related complications through one month post MRI. The primary effectiveness endpoint tested equivalence between MRI versus control for atrial and ventricular pacing capture thresholds and atrial and ventricular sensed amplitudes through one month post MRI.
Revo MRI has been designed to address safety concerns around MRI procedures for patients who have implanted pacemakers. Revo MRI includes hardware modifications to the device and leads that are designed to reduce or eliminate several hazards produced by the MRI environment. In addition, the new pacemaker includes a new SureScan feature that sets the device into an appropriate mode for the MRI environment.
The company said that the device and leads also contain radiopaque markers, viewable via X-ray, to indicate that the device is MR-Conditional. MR-Conditional is 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.
Pat Mackin, president of the cardiac rhythm disease management business and senior vice president at Medtronic, said: “MRI is critical in the diagnosis of many serious conditions; however, patients with current pacemakers most often do not have access to this vital technology. The result of panel brings Medtronic one step closer to helping address an important unmet patient need. We look forward to working with the FDA during the regulatory process so that we may provide certain pacemaker patients with access to MRI scans.”