On Friday, Feb. 18, 2011, Dr. Brian Seeck, MD, an interventional cardiologist with SSM HeartInstitute at St. Clare Health Center, was among the first physicians in the country to implant the first FDA-approved pacemaker that is considered safe for MRI exams. Mary Allen of Shrewsbury is the patient who benefitted from the new technology available from Medtronic, Inc.
ST. LOUIS — The SSM Heart Institute has 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. On Friday, Feb. 18, SSM Heart Institute cardiologist, Dr. Brian Seeck, was among the first in the nation to implant the pacing system. The procedure took place at the SSM Heart Institute at St. Clare Health Center in Fenton, Mo. 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.
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. 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. About 40 million MRI scans are performed in the United States each year. MRI is often preferred by physicians because it provides a level of detail and clarity not offered by other soft tissue imaging modalities. Among the 1.5 million Americans with pacemakers, 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 . Furthermore, more than 200,000 patients annually in the U.S. have to forego an MRI scan because they have a pacemaker. 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 John Kilgore, M.D., medical director of the SSM Heart Institute. “The SSM Heart Institute 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 1 (800) 328-2518. For more information about Revo MRI go to www.medtronic.com/patient/revomri.
About SSM Heart Institute
The SSM Heart Institute is the region’s most experienced provider of comprehensive heart care. A team of more than 100 skilled cardiologists, electrophysiologists and cardiothoracic surgeons provides the most advanced treatments, leading-edge techniques and unparalleled experience for the best clinical outcomes. Combined with expert nursing and technical staff, this team offers a full range of services to prevent, diagnose and treat heart disease. SSM Heart Institute services are available at five locations across the St. Louis area: DePaul Health Center, St. Clare Health Center, St. Joseph Health Center, St. Joseph Hospital West and St. Mary’s Health Center.
About Revo MRI™ SureScan® Pacing System
The Revo MRI SureScan pacing system was designed to address safety concerns around MRI procedures for patients who have implanted pacemakers. The Revo MRI SureScan pacing system includes hardware modifications to the device and leads that are designed to reduce or eliminate several hazards produced by the MRI environment. In addition, since MRI scanners may cause traditional pacemakers to misinterpret MRI-generated electrical noise and withhold pacing therapy or deliver unnecessary pacing therapy, this new pacemaker includes new SureScan technology that sets the device into an appropriate mode for the MRI environment.
MR-Conditional is a term used to indicate that a device may be used in the MRI environment under certain conditions, such as a particular type of MRI scanner and scanner settings .