Medtronic Receives FDA Approval for Advisa DR MRI SureScan Pacing System Clinical Trial

Medtronic, Inc. MDT today announced U.S. Food and Drug Administration approval for its Investigational Device Exemption application and pivotal clinical trial protocol to begin evaluating Advisa DR MRI™ SureScan® pacing system. FDA approval of the Advisa MRI System Study protocol enables Medtronic to become the first company to conduct a randomized, controlled clinical trial of a second generation pacing system designed for use in the MRI environment under specific scanning conditions in the U.S. The Advisa DR MRI SureScan pacing system is not approved by the FDA for U.S. commercial distribution. “This clinical trial is an important milestone toward providing another innovative pacing system option for patients who may need access to the potentially life-saving benefits of MRI technology during the lifetime of their device,” said Edward J. Schloss, M.D., medical director of electrophysiology at The Christ Hospital in Cincinnati, OH.