July 17, 2009 – Medtronic announced today the first enrollments in a magnetic resonance imaging (MRI) substudy of the global PANORAMA registry.
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.
The EnRhythm MRI and Advisa MRI SureScan pacing systems enable patients to access MRI scans. The EnRhythm MRI and Advisa MRI SureScan pacing systems are not currently available for sale in the U.S., and no U.S. patients will be enrolled in the substudy.
The PANORAMA registry is collecting long-term product performance data on all types of Medtronic cardiac rhythm disease management devices implanted outside the U.S., including pacemakers, implantable cardioverter-defibrillators (ICDs), cardiac resynchronization therapy devices (CRTs), leads and insertable cardiac monitors (ICMs). For more than 25 years, Medtronic has published twice-annual product performance reports. The latest report, the 2009 First Edition, Issue 60, includes data applicable to more than 13.8 million implanted cardiac devices and leads worldwide.
The PANORAMA registry was initiated in 2005 and will involve 10,000 patients at 150 centers in 33 countries on four continents. PANORAMA parallels both the company's System Longevity Study (SLS) and OMNI study in the U.S. In addition to long-term device surveillance, PANORAMA is assessing adherence to and adoption of medical society practice guidelines for implanted cardiac devices.
The MRI substudy will involve up to 1,500 patients at 120 centers as part of the ongoing PANORAMA initiative and will collect MRI-related epidemiological data on patients outside the U.S. who have received a market-approved Medtronic pacing system for use with MRI machines, the EnRhythm MRI SureScan or Advisa MRI SureScan pacing systems; the referral process for patients who require an MRI scan; and long-term data on system performance, as well as system performance when exposed to MRI scans, among others.
For more information: www.medtronic.com