FDA Approves Medtronic IDE, Clinical Trial Protocol
Medtronic, Inc. (NYSE: MDT), a Minneapolis, Minn.-based developer of interventional devices, has received U.S. Food and Drug Administration (FDA) approval of its Investigational Device Exemption (IDE) application and clinical trial protocol to begin evaluating its 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. pacing system option for patients who may need access to MRI technology during the lifetime of their device,” says Edward J. Schloss, MD, medical director of electrophysiology at The Christ Hospital in Cincinnati, Ohio.Schloss implanted the first patient in the U.S. with the investigational Advisa MRI System as part of a clinical trial through The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital. The Advisa MRI study is a prospective, randomized-controlled, non-blinded, multi-center worldwide investigational study to confirm the safety and effectiveness of the pacing system in the clinical MRI environment when subjects receive MRI scans under specified conditions, as well as to provide data on MRI image quality in the presence of the pacing system.