FDA Approves Medtronic’s MRI-Friendly Pacemaker

The FDA has approved the Advisa DR MRI SureScan pacing system, a second-generation pacemaker designed for use with MRI machines, according to device maker Medtronic.

Advisa MRI was specifically tested and approved for use as labeled with MRI scanners in the U.S. According to Medtronic, 156 patients were scanned in a clinical trial for the device and none showed MRI-related complications.

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

“Your physician can implant a pacemaker with advanced options that will allow for broad access to MRI scanning,” J. Rod Gimbel, MD, of Cardiology Associates of East Tennessee in Knoxville, Tenn, said in a release from Medtronic.

Medtronic introduced the first SureScan pacemaker system in Europe in 2008, and more than 100,000 SureScan devices have been sold worldwide. In the U.S., an estimated more than 10 percent of patient with SureScan systems have received MRIs, the company said.

Advisa MRI pacing system includes a Managed Ventricular Pacing algorithm to reduce unnecessary ventricular pacing, complete capture management to automatically test and adjust the energy supplied to the heart, higher upper tracking rates to allow the pacemaker to keep up with quicker heart rates, and rate drop response to reduce frequency of fainting in patients.