FDA Clears First MRI-Safe Pacemaker

 

February 9, 2011

February 9, 2011 – The U.S. Food and Drug Administration (FDA) approved the first pacemaker in the United States specifically designed for use in an magnetic resonance imaging (MRI) environment and approved as MRI-conditional. Medtronic said its Revo MRI SureScan pacing system is available immediately.

Until now, MRI procedures had been contraindicated for patients with implanted pacemakers due to the potential for serious adverse events. Each year, an estimated 200,000 pacemaker patients in the United States have to forgo MRI scans, which are critical for making a wide range of health diagnoses.

“The new Revo MRI pacemaker is a major technological breakthrough for patients who need access to MRI,” said J. Rod Gimbel, M.D., of Cardiology Associates of East Tennessee in Knoxville, Tenn. “Providing pacemaker patients with access to MRI allows detection and treatment of serious medical conditions such as stroke, cancer, and a wide variety of important neurologic and orthopedic conditions.”

As the population ages, the use of pacemakers is growing, with approximately 5 million patients worldwide who currently are implanted with a pacemaker or implantable cardioverter-defribrillator. At the same time, the use of MRI as a diagnostic tool is increasing, with approximately 30 million scans completed in 2007. Individuals over age 65 are twice as likely to need an MRI compared with younger patients, and between 50 and 75 percent of patients with electronic cardiac devices will likely need an MRI over their device’s lifetime.

Prior to the introduction of Revo MRI, pacemaker patients could face serious complications if they were exposed to the powerful magnetic fields generated by MRI machines, which can be as much as 30,000 times more powerful than the earth’s magnetic field. Complications to exposure could include 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.

The Revo MRI pacing system must consist solely of a Medtronic Revo MRI SureScan device and two CapSureFix MRI SureScan Model 5086MRI leads. Prior to scanning a patient, refer to the Revo MRI conditions for use located in the device manuals.

For more information: www.medtronic.com/patient/revomri

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