February 17, 2011
MONTGOMERY – Today, Baptist Medical Center South announced that it will be offering Revo MRI™ SureScan® pacing system, the first MR-Conditional pacing system designed, tested and FDA approved for use in the Magnetic Resonance Imaging (MRI) environment. Prior to the Revo MRI SureScan pacing system, MRI procedures for patients with implanted pacemakers were not recommended because these patients might face serious complications, such as interference with pacemaker operation, damage to system components, lead or pacemaker dislodgement or change in pacing capture threshold[i],[ii],[iii],[iv].
Developed by Medtronic (NYSE: MDT), the Revo MRI SureScan pacing system is the first pacing system of its kind in the U.S. The Revo MRI SureScan pacing system was designed to address safety concerns around MRI procedures for patients who have implanted pacemakers. MRI scanners may cause traditional pacemakers to misinterpret MRI-generated electrical noise and withhold pacing therapy or deliver unnecessary pacing therapy[v],[vi],[vii],[viii],[ix],[x],[xi],[xii],[xiii],[xiv]. The Revo MRI pacing system, when programmed into SureScan mode prior to an MRI scan, is designed to be used safely in the MRI environment.
The number of patients with pacemakers is growing at the same time that the use of MRI is increasing[xv],[xvi]. About 40 million MRI scans are performed annually in the United States. MRI is often preferred by physicians because it provides a level of detail and clarity not offered by other soft tissue imaging modalities[xvii].
It has been estimated that there is a 50 to 75 percent probability that cardiac device patients will be indicated for an MRI over the lifetime of their devices[xviii]. Furthermore, more than 200,000 patients annually in the U.S. have to forego an MRI scan because they have a pacemaker[xix]. The Revo MRI SureScan pacing system can help address this important unmet patient need.
“Medical imaging and electronic implantable devices such as pacemakers are important technological advances, particularly for older people,” said Jeff Hicks, vice president, Baptist Medical Center South. “Baptist South is proud to provide safer access to MRI for our patients. We encourage our patients to talk to their doctor about which pacing system is right for them.”
A complete SureScan pacing system including a Revo MRI SureScan IPG and two CapSure Fix MRI™ SureScan leads is required for use in the MRI environment. Any other combination may result in a hazard to the patient during an MRI scan. The SureScan feature must be programmed to On prior to scanning a patient according to the specified conditions for use. Refer to the Revo MRI Pacing System Conditions for Use located in the device manuals prior to scanning a patient. Consult Medtronic’s website at www.medtronic.com or call Medtronic at (800) 328-2518. For more information about Revo MRI go to www.medtronic.com/patient/revomri.
[i] Faris OP, Shein M. Food and Drug Administration perspective: Magnetic resonance imaging of pacemaker and implantable cardioverter-defibrillator patients. Circulation 2006;114:1232-1233.
[ii] Roguin A, Schwitter J, Vahlhaus C, et al. Magnetic resonance imaging in individuals with cardiovascular implantable electronic devices. Europace 2008;10:336-346.
[iii] Levine GN, Gomes AS, Arai AE, et al. Safety of magnetic resonance imaging in patients with cardiovascular devices: an American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention: endorsed by the American College of Cardiology Foundation, the North American Society for Cardiac Imaging, and the Society for Cardiovascular Magnetic Resonance. Circulation 2007;116:2878-2891.
[iv] Kalin R and Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE 2005;28:326-328.
[v] Levine GN, et al. Safety of magnetic resonance imaging in patients with cardiovascular devices: An American Heart Association scientific statement from the Committee on Diagnostic and Interventional Cardiac Catheterization, Council on Clinical Cardiology, and the Council on Cardiovascular Radiology and Intervention. Circulation 116 (2007): 2878-2891.
[vi] Luchinger RC. Safety Aspects of Cardiac Pacemakers in Magnetic Resonance Imaging. Dissertation, Swiss Federal Institute of Technology Zurich, Diss. ETH no 14655, (2002).
[vii] Duru F, Luechinger R, Scheidegger MB, Luscher TF, Boesiger P and Candinas R. Pacing in magnetic resonance imaging environment: Clinical and technical considerations on compatibility. European Heart Journal volume 22 issue 2 (2001): 113-124.
[viii] Nair P and Roguin A. “Magnetic resonance imaging in patients with ICDs and pacemakers.” Indian Pacing and Electrophysiology Journal 5 (2005): 197-209.
[ix] Price RR. “The AAPM/RSNA physics tutorial for residents. MR imaging safety considerations.” Radiographics - a review publication of the Radiological Society of North America, Inc. 19 (1999): 1641-1651.
[x] United States Food and Drug Administration Center for Devices and Radiological Health, A primer on medical device interactions with magnetic resonance imaging systems, 1997. Available at: http://www.fda.gov/cdrh/ode/primerf6.html.
[xi] Kanal E, et al. ACR guidance document for safe MR practices: 2007. American Journal of Roentgenology 188 (2007):1447-1474.
[xii] Shellock FG and Crues JV. MR procedures: biologic effects, safety, and patient care. Radiology 232 (2004): 635– 652.
[xiii] Schaefer DJ, Bourland JD and Nyenhuis JA. Review of patient safety in time-varying gradient fields. Journal of Magnetic Resonance Imaging 12 (2000): 20-9.
[xiv] Bhachu DS and Kanal E. Implantable pulse generators (pacemakers) and electrodes: safety in the magnetic resonance imaging scanner environment. Journal of Magnetic Resonance Imaging 12 (2002): 201-4. [xv] IMV, “Benchmark Report: MRI 2007,” IMV Medical Information Division. Des Plaines, IL. 2008.
[xvi] Zhan C, Baine WB, Sedrakyan, A, et al. Cardiac device implantation in the United States from 1997 through 2004: A population-based analysis. J Gen Intern Med 2008; 23(Suppl 1): 13-19.
[xvii] Semelka RC, et al. Imaging Strategies to Reduce the Risk of Radiation in CT Studies, Including Selective Substitution With MRI. Journal of Magnetic Resonance Imaging 2007; 25: 900-909.
[xviii] Kalin R and Stanton MS. Current clinical issues for MRI scanning of pacemaker and defibrillator patients. PACE 2005;28:326-328.
[xix] Medtronic calculations cited in Rod Gimbel and Ted McKenna, “Safety of Implantable Pacemakers and Cardioverter Defibrillators in the Magnetic Resonance Imaging Environment,” Business Briefing: Long-Term Healthcare 2005 (2005) available at www.touchbriefings.com.