The FDA has approved Medtronic's Advisa DR MRI SureScan pacing system, and the company has immediately commenced its U.S. launch. The Advisa MRI system is Medtronic’s second-generation MR-conditional pacemaker.
MRI is the standard of care in soft tissue imaging, providing information not seen with x-ray, ultrasound or CT scans, and is critical for early detection, diagnosis and treatment. Advisa MRI was tested and approved for use as labeled with MRI scanners in the U.S., according to the Minneapolis-based company. The new system includes an Advisa MRI device and two CapSureFix MRI SureScan leads, which must be used together.
The first SureScan pacemaker system was introduced in Europe in 2008 for use in the MRI environment. Medtronic’s first-generation Revo MRI SureScan pacing system was the only FDA approved (February 2011) MR-conditional pacemaker in the U.S. before the Advisa MRI system.