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.