Medtronic’s MRI Pacemaker Receives FDA Approval

The medical device giant received approval for a pacemaker that is the first and only its kind in the United States specifically designed for use in magnetic resonance imaging (MRI) machines.

Fridley-based Medtronic, Inc., announced Tuesday that its Revo MRI SureScan Pacing System-the first and only pacemaker in the United States specifically designed for use in magnetic resonance imaging (MRI) machines-has received approval from the U.S. Food and Drug Administration.

MRIs allow doctors to see internal organs, blood vessels, muscles, joints, tumors, areas of infection, and more, without X-rays or surgery, and without exposing patients to ionizing radiation.

An MRI scan is the standard of care in soft tissue imaging, providing information not seen with an X-ray, ultrasound, or CAT scan. MRI is therefore critical for the early detection, diagnosis, and treatment of many diseases.

According to Medtronic, an estimated 200,000 pacemaker patients in the United States have to forgo MRI scans because of the potential for serious adverse events-including damage to system components or a change in pacing capture threshold.

The company said that shipments of the pacemaker will start immediately.

“The new Revo MRI pacemaker is a major technological breakthrough for patients who need access to MRI,” Dr. J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville, Tennesee, said in a statement. “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.”

Medtronic is Minnesota's seventh-largest public company based on revenue, which totaled $15.8 billion in its most recently completed fiscal year.