Medtronic Demonstrates Concrete Results On First Pacemaker Designed For Use With MRI
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Distinct data announced at Heart Rhythm 2009, the annual congress of the Passion Rhythm Society, show that patients implanted with the investigational EnRhythm MRI™ SureScan™ pacing operation experienced no complications related to the application of attractive resonance imaging (MRI). Sponsored by Medtronic, Inc. (NYSE: MDT), the study confirms that the pacing manner can help cardiac device patients benefit from the apply of MRI, a critical imaging mode commonly used in disease diagnosis. Currently, due to safety considerations, there are no implantable pacemakers or defibrillators approved for use with MRI in the United States. Commercially released in Europe persist fall, the EnRhythm MRI SureScan course is the world's first and alone pacing method designed and approved for operate with MRI.
Patients with currently implanted pacemaker and defibrillator systems are strongly discouraged from receiving an MRI scan, according to medical guidelines and the U.S. Cheer and Narcotic Administration. Studies have shown that commonly used MRI scanners can interrupt or withhold pacing therapy, deliver avoidable pacing therapy that may be hazardous and possibly life-threatening, and/or cause damage to the device, regardless of which company manufactured the device.
"Each year, all over one million people are implanted with a pacemaker, thousands of whom should apprehend diagnostic MRI scans," said Bruce L. Wilkoff, M.D., director of Cardiac Pacing & Tachyarrhythmia Devices, Branch of Cardiovascular Medicine and professor of medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. "This investigational scan showed acceptable results, indicating that copious more patients may annex access to MRI, a vital and usually irreplaceable thing in detecting and managing conditions such as cancer and neurological disorders." Dr. Wilkoff is a paid consultant assisting Medtronic in the buildup of this therapy.
Results showed that Medtronic's investigational EnRhythm MRI SureScan pacing transaction yet performs as intended during and after an MRI when used according to the product's labeling. The information showed no MRI-related complications, and no arrhythmias, or asystole (absence of electrical movement in the heart) during MRI scans.
"Despite well-documented risks and warnings of MRI-related complications, pacemaker patients do be given MRI scans off label," said David Steinhaus, M.D., medical director of the Cardiac Rhythm Disease State business at Medtronic. "Physicians and patients faced with pressing clinical needs own had to make difficult risk/benefit decisions and accept the risks of an MRI scan. Washed-up our process process, we identified real risks and designed a development to address these risks for pacemaker patients. We are encouraged by the clinical results of the EnRhythm MRI SureScan pacing system, as we presume that providing guarded access to MRI for pacemaker patients can reduce risk and heavy to exceptional health outcomes."
About the EnRhythm MRI SureScan Pacing System Clinical Trial
This prospective, randomized, controlled trial involved 464 individuals successfully implanted at 41 centers in the U.S., Canada, Europe and the Middle East. After fortuitous implant of pacemaker and leads, 258 patients were randomized to MRI and 206 to no MRI (control). All patients were evaluated before and after the scan, and one week and one month after MRI scan/control visit. There was no difference in performance between the MRI assembly and the domination group.
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