Clinical Registry Begins Collecting Data on Industry's Only Pacing Systems Approved for Use in MRI Machines
Medtronic SureScan Pacing Systems Enable Patients to Access Key Imaging Diagnostics
MINNEAPOLIS - July 16, 2009 - Medtronic, Inc. (NYSE: MDT) today announced first enrollments in a magnetic resonance imaging (MRI) substudy of the global PANORAMA registry, the largest and most comprehensive registry - with centers on four continents - collecting implanted cardiac rhythm device data in the world. 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 MRITM SureScanTM pacing system.
"With Medtronic's EnRhythm MRI and Advisa MRITM SureScanTM 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 U.S. 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.
About PANORAMA and the MRI Substudy
The PANORAMA registry was initiated in 2005; it 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 United States. SLS has been capturing data for more than 25 years, and is designed to monitor the performance of commercially available implantable cardiac leads and devices; OMNI is the first large-scale longitudinal registry to follow nearly 3,000 real-world device patients. 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 United States 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 these systems' performance when exposed to MRI scans, among others.