Medtronic Receives FDA Approval for First and Only Pacemaker System in the U.S. Designed for Use in the MRI Environment

MINNEAPOLIS – February 8, 2011 – Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) approved its Revo MRI™ SureScan® pacing system, the first and only pacemaker in the U.S. specifically designed for use in an Magnetic Resonance Imaging (MRI) environment and approved as MR-Conditional. Shipments of Revo MRI will begin immediately.

Until now, MRI procedures had been contraindicated for patients with implanted pacemakers due to the potential for serious adverse events.i,ii,iii,iv 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.iv

“The new Revo MRI pacemaker is a major technological breakthrough for patients who need access to MRI,” said Dr. J. Rod Gimbel 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.”

source: Medtronic