The US Food and Drug Administration (FDA) has approved Medtronic's investigational device exemption (IDE) application to commence Advisa DR MRI SureScan pacing system clinical trial.
The controlled, multi-center, non-blinded, prospective, randomized trial is designed to assess safety and effectiveness of the second generation pacing system in the clinical MRI environment when subjects receive MRI scans and provide data on MRI image quality in the presence of pacing system.
The second generation pacing system was implanted in the US by Edward Schloss, medical director of electrophysiology through The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital.
The Advisa MRI system uses SureScan technology and is constituted of the Advisa MRI IPG Model A2DR01 and the CapSureFix MRI active fixation Model 5086MRI lead.
Medtronic Cardiac Rhythm Disease Management business president Pat Mackin said the FDA approval of the Advisa MRI System Study protocol provides patients with another pacemaker option designed for safe use in the MRI environment.
"This clinical trial further demonstrates Medtronic’s commitment with clinically proven technologies that enable physicians to help sustain health and extend life," Mackin said.