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Advisa MRI pacing system receives FDA approval

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Medtronic today announced that the FDA approved its second-generation Advisa DR MRI SureScan, which was specifically tested and approved for use with MRI scanners in the US.

The Advisa MRI pacing system features include complete automaticity with Ventricular and Atrial Capture Management to eliminate manual threshold checks and extend longevity of the device; diagnostic and management tools to assist in the early detection and treatment of atrial fibrillation; remote monitoring by Medtronic's CareLink Network; rate drop response; and high upper tracking rate to provide support at higher heart rates for active and younger patients.

According to the release, none of the 156 patients evaluated in the Advisa MRI Clinical Trial demonstrated any MRI-related complications.

"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, said in the press release. "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% 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."