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St. Vincent Healthcare Announces Revo MRI™ SureScan® Pacing System

May 03, 2011

St. Vincent Healthcare announced the Revo MRITM SureScan® pacing system, the first MR-Conditional pacing system designed, tested and FDA approved for use with a Magnetic Resonance Imaging (MRI). Prior to the Revo MRI SureScan pacing system, MRI procedures for patients with implanted pacemakers were not recommended as these patients may face serious complications, such as interference with pacemaker operation, damage to system components, lead or pacemaker dislodgement or change in pacing capture threshold.

The Revo MRI SureScan is the first pacing system of its kind in the United States; it 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 either withhold 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 Dr. Mike Schweitzer, Chief Medical Officer, St. Vincent Healthcare. "St. Vincent Healthcare is proud to provide safer access to MRI for our patients. We encourage our patients to talk to their doctor to determine if this pacing system is right for them."

The number of patients with pacemakers is growing as the use of MRI increases. About 40 million MRI scans are performed annually in the United States; St. Vincent Healthcare performs approximately 300 MRI scans each month. MRI is often preferred by physicians because it provides a level of detail and clarity not offered by other soft tissue imaging modalities.

There is an estimated 50 to 75 percent probability cardiac device patients will be indicated for an MRI over the lifetime of their device and more than 200,000 U.S. patients annually forego an MRI scan due to having a pacemaker. The Revo MRI SureScan pacing system addresses this important unmet patient need.