FDA says Medtronic's pacemakers are safe with MRI

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Medtronic, Inc. today mentioned that the United States Food and Drug Administration (FDA) has Medtronic_logoapproved, with conditions, the use of Revo MRI SureScan pacing system. The system was developed to be safe with MRI scans. It is not recommended in the United States that patients with pacemakers perform MRI. Yet, Revo MRI would be the first FDA-approved pacing device developed to be compatible with the use of MRI.

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,” he added “The result of today’s 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.”

It is a fact that the number of MRI scans carried out is increasing every year. In the same time, the number of people having pacemakers is increasing as well. In 2007, there were nearly 30 million MRI scans performed in the United States and that number is still growing. Estimations say that more than 200,000 patients per year in the United States are not having an MRI scan because they use a pacemaker as there are risks of having such scans. Among these risks is interference with pacemaker operation, occurrence of damage to system components, increase in the temperature of the lead tips and even unwanted cardiac stimulation. Yet, MRI scans permit physicians to have diagnosis aided by viewing highly quality images of internal organs, muscles, joints, and tumors.

The FDA revised safety and effectiveness data obtained from multicenter trial carried out at 42 centers around the world involving 464 patients having pacemakers. The use of Revo MRI pacing system in the MRI environment was assessed. For safety, the patients with pacemakers where checked for MRI related complications within one month after the carrying out of MRI. While effectiveness was determined by testing the equivalence between MRI group against control for atrial/ ventricular pacing capture thresholds and atrial/ ventricular sensed amplitudes in one month time after MRI.

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