Medtronic, Inc announced first enrollments in a magnetic resonance imaging (MRI) substudy of the global PANORAMA registry. The registry with centers on four continents is collecting implanted cardiac rhythm device data. Dr. Raed Sweidan, consultant electrophysiologist and head of the EP Department at King Fahd Armed Forces Hospital in Jeddah, Saudi Arabia, enrolled the first patient, who received a Medtronic EnRhythm MRI SureScan pacing system.
“With Medtronic’s EnRhythm MRI and Advisa MRI SureScan pacing systems, which will enable thousands of patients to access MRI scans, extending the PANORAMA registry to include these systems reinforces the breadth and depth of our industry-leading, post-market quality systems,” said David Steinhaus, M.D., medical director for the Cardiac Rhythm Disease Management business at Medtronic.
The EnRhythm MRI and Advisa MRI SureScan pacing systems currently are not available for sale in the United States; further, no US patients will be enrolled in the MRI substudy.
The PANORAMA registry is collecting long-term product performance data on all types of Medtronic Cardiac Rhythm Disease Management devices implanted outside the United States, including pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy devices (CRTs), leads (thin wires that connect certain implanted cardiac devices to the heart) and insertable cardiac monitors (ICMs). For more than 25 years, Medtronic has published twice-annual product performance reports, the latest of which (2009 First Edition, Issue 60) includes data applicable to more than 13.8 million implanted cardiac devices and leads worldwide.