Medtronic Receives FDA Panel's Unanimous Recommendation for Approval of Revo MRI(TM) SureScan(TM) Pacing System

MINNEAPOLIS – March 19, 2010 – Medtronic, Inc. (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has voted unanimously in favor of approval with conditions of the Revo MRI™ SureScan™ pacing system designed as MR Conditional, or safe for use in Magnetic Resonance Imaging (MRI) systems under specified conditions. MRI procedures are not recommended in the United States for patients who currently have implanted pacemakers; if approved, Revo MRI has the potential to be the first FDA-approved pacing system designed for use in the MRI setting.

The FDA’s Circulatory System Devices Panel, which met today, recommended Revo MRI for approval with conditions related to the planned post-market study, health care professional training, and labeling to reflect MRI scans are to be conducted with the full 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.

“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,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “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.”

source: Medtronic