The FDA approved Medtronic’s Investigational Device Exemption application and clinical trial protocol to assess the safety and effectiveness of the Advisa DR MRI Surescan pacing system in a clinical MRI setting. The study will also provide data on how the MRI image quality is affected by the presence of an implanted pacemaker.
The device, as reported prior on Medgadget, has already received European approval in the past. This will be the 2nd MRI compatible system potentially to be available in the US. The first being Medtronic’s Revo MRI SureScan that received approval last February.
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(TM) active fixation Model 5086MRI lead.