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Baylor Hamilton Heart Hospital Implants First MRI-Safe Pacemaker in North Texas
Date:2/21/2011

DALLAS, Feb. 21, 2011 /PRNewswire-USNewswire/ -- Baylor Jack and Jane Hamilton Heart and Vascular Hospital announced that it implanted the first MRI-safe pacemaker in North Texas last week and the patient has fully recovered.

(Photo:  http://photos.prnewswire.com/prnh/20110221/DC51859)

An interventional cardiologist on the hospital's medical staff successfully used the 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.

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 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.

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(i). The Revo MRI SureScan pacing system can help address this important unmet patient need.

Developed by Medtronic, 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.

"Medical imaging and electronic implantable devices such as pacemakers are important technological advances, particularly for older people," said Nancy Vish, RN, Ph.D., Baylor Hamilton's president. "Baylor Hamilton Heart and Vascular Hospital 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 Baylor Jack and Jane Hamilton Heart and Vascular Hospital

Baylor Jack and Jane Hamilton Heart and Vascular Hospital (Baylor Hamilton) was the first hospital in North Texas dedicated solely to the care and treatment of patients with cardiovascular disease. The 64-bed Baylor Hamilton was recognized in 2010 for having the nation's lowest readmission rate for heart failure patients for the second consecutive year and continues to receive a five star rating by HealthGrades, a leading independent health care rating organization. For more information about Baylor Hamilton Heart and Vascular Hospital, visit www.BaylorHeartHospital.com.

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(ii).

(i) 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.

(ii) Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment, ASTM F2503-08, 2008. [Online]. Available: www.astm.org.  


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