Medtronic’s Advisa MRI SureScan Pacemaker Finally Cleared in U.S.

Medtronic won FDA approval for the Advisa DR MRI SureScan, an MR-Conditional pacemaker that’s had European approval for years now.  The pacemaker is paired with the CapSureFix MRI SureScan leads for a complete MR compatible system. From Medtronic:

Advisa MRI was specifically tested and approved for use as labeled with MRI scanners in the U.S. Of the 156 patients scanned in the Advisa MRI Clinical Trial, none showed any MRI-related complications. The new system includes an Advisa MRI device and two CapSureFix MRI(TM) SureScan leads, which must be used together.

The first SureScan pacemaker system was introduced in Europe in 2008 and its use in the MRI environment is supported by clinical studies and extensive computer modeling, as well as real-world data. To date, more than 100,000 Medtronic SureScan devices have been sold worldwide;[1] and, in the U.S., it is estimated that more than 10 percent of patients with SureScan pacing systems have received MRIs.[2] These patients received Medtronic’s first-generation Revo MRI SureScan pacing system, which was the only FDA approved (February 2011) MR-Conditional pacemaker in the U.S. before the Advisa MRI system.

Flashbacks: Medtronic’s New MRI Compatible Pacemaker Gets CE Mark; Medtronic’s Second MRI Compatible Pacing System Gets FDA Approval for a US Clinical Trial

Product page: Advisa MRI SureScan Pacemaker…

Press release: Medtronic Announces FDA Approval and Launch of Its Advisa MRI Pacemaker System