First Pacemaker Approved for use in the Magnetic Resonance Imaging (MRI)
Today, Cooper University Hospital placed a Revo MRI™ SureScan® pacing system into a patient. This is 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.
Paul Williams, 66, of Waterfordworks, N.J., developed sinus dysfunction, a heart condition that requires a medical device which uses electrical impulses to regulate the beating of the heart. Mr. Williams however, is a thyroid cancer survivor and his physicians recommend MRI scans to monitor any possible cancer recurrence. He was the first patient in the region to receive the Revo MRI™ SureScan® pacing system this morning.
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. 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 John A. Andriulli, DO, Director of Arrhythmia Device Program at Cooper. “As our population ages, patients come to us with multiple conditions that need to be monitored throughout their lives. This technology gives us an advantage we have never had before.”
“We believe this will become the standard of care for patients who require implantable devices,” said Andrea M. Russo, MD, Director of Electrophysiology and Arrhythmia at Cooper.
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.