FDA green-lights Medtronic's trial for MRI-safe pacemaker
The FDA has approved Medtronic’s investigational device exemption application and clinical trial protocol to begin evaluating Advisa DR MRI SureScan pacing system.
This approval of the protocol allows Medtronic 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.
The Advisa MRI study is a prospective, randomized controlled, non-blinded, multicenter, global 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 a 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.
Up until FDA approval of Medtronic’s first-generation Revo MRI SureScan pacing system in February, MRI procedures had been contraindicated for patients with implanted pacemakers due to the potential for serious adverse events. It is estimated that 50 to 75 percent of patients with an implantable cardiac device will need an MRI scan over the lifetime of their device.
This approval of the protocol allows Medtronic 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.
The Advisa MRI study is a prospective, randomized controlled, non-blinded, multicenter, global 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 a 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.
Up until FDA approval of Medtronic’s first-generation Revo MRI SureScan pacing system in February, MRI procedures had been contraindicated for patients with implanted pacemakers due to the potential for serious adverse events. It is estimated that 50 to 75 percent of patients with an implantable cardiac device will need an MRI scan over the lifetime of their device.