FDA Nod For Medtronic’s New MRI-Friendly Pacing System

In short

Medtronic, Inc. tells us it has gained FDA approval and will commence the U.S. launch of its Advisa DR MRI™ SureScan® pacing system. The system is Medtronic’s second-generation MR-Conditional pacemaker and is the first to combine the most advanced pacing technology with proven MRI access.


MRI is the standard of care in soft tissue imaging, providing information not seen with X-ray, ultrasound or CT scans. It is considered a critical imaging modality for early detection, diagnosis and treatment. Indeed current thinking has it that up to 75 percent of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.

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 modelling, as well as real-world data.

To date, more than 100,000 Medtronic SureScan devices have been sold worldwide and in the U.S. it is estimated that more than 10 percent of patients with SureScan pacing systems have received MRIs. These patients received Medtronic’s first-generation Revo MRI® SureScan® pacing system, which was the only FDA approved MR-Conditional pacemaker in the U.S. before the Advisa MRI system.

Until the availability of Medtronic’s SureScan pacing systems, patients with pacemakers in the U.S. have been contraindicated from receiving MRI scans because of potential interactions between the MRI and device function.

Advisa MRI was specifically tested and approved for use with MRI scanners in the U.S. Results showed that none of the 156 patients scanned in the clinical trial, showed any MRI-related complications.

The new system includes an Advisa MRI device and two CapSureFix MRI™ SureScan® leads, which Medtronic says must be used together.

Physician comments

“Your physician can implant a pacemaker with advanced options that will allow for broad access to MRI scanning,” said Dr. J. Rod Gimbel of Cardiology Associates of East Tennessee in Knoxville, Tenn. “MRI is just so very important and traditional pacemakers not FDA approved for MRI scanning often prevent the patient from having an MRI when they need it. With more than 85 percent of pacemaker patients being at least 65 years old and having multiple comorbidities for which MRI may be needed, it’s key that physicians and patients have a pacing system that allows MRI imaging as a diagnostic procedure.”

Source: Medtronic, Inc.