Southeast Georgia Health System Implants First Revo MRI™ SureScan® Pacing System

BRUNSWICK, Georgia: Feb. 21, 2011 – On Friday, February 18, Mark Watkins, M.D., cardiologist with Coastal Cardiology, and Southeast Georgia Health System implanted its first 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. This implant procedure is a first of its kind in Coastal Georgia area and Jacksonville. 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 annually in the United States and Southeast Georgia Health System performs approximately 7,300 MRI scans 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 .

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 Gary R. Colberg, FACHE, Southeast Georgia Health System President & CEO. “The Health System 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.