Medtronic, Inc. (NYSE: MDT) today announced U.S. Food and Drug Administration (FDA) approval for its Investigational Device Exemption (IDE) 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”
"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.
Dr. Schloss implanted the first patient in the U.S. with the investigational Advisa MRI System as part of the clinical trial through The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati.
The Advisa MRI study is a prospective, randomized controlled, non-blinded, multi-center worldwide investigational study to confirm safety and effectiveness of the pacing system in the clinical MRI environment when subjects receive MRI scans under specified conditions, as well as provide data on MRI image quality in the presence of pacing system. In the U.S., the Medtronic Advisa MRI System featuring the SureScan technology is comprised of the Advisa MRI IPG Model A2DR01 and the CapSureFix MRI™ active fixation Model 5086MRI lead.
Until FDA approval of Medtronic's first-generation Revo MRI™ SureScan® pacing system in February 2011, MRI procedures had been contraindicated for patients with implanted pacemakers due to the potential for serious adverse events.i,ii,iii,iv MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray, ultrasound, or CT scan, and critical for early detection, diagnosis and treatment. It is estimated that 50 - 75 percent of patients with an implantable cardiac device will need an MRI scan over the lifetime of their device.
"The FDA approval of the Advisa MRI System Study protocol brings us one step closer to providing patients with another pacemaker option designed for safe use in the MRI environment," said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. "This clinical trial further demonstrates Medtronic's commitment to leading the industry with clinically proven innovative technologies that enable physicians to help sustain health and extend life."