EP Lab Digest - January 2008 - (Page 43) JANUARY 2008 NEWS 43 Medtronic Implantable Cardiac Monitors Give Physicians Valuable Insights into Heart Rhythms he new Reveal devices expand on the cardiac monitoring foundation Medtronic began more than 10 years ago with the Reveal® and Reveal Plus® Insertable Loop Recorders. The Reveal DX will be commercially available in the United States beginning next week; the Reveal XT will follow. The Reveal DX continuously monitors the heart’s electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. Approximately 1.5 million people worldwide suffer from unexplained syncope. In almost 10 percent of patients, syncope has a cardiac cause; in 50 percent, a non-cardiac cause; and in 40 percent of patients the cause of syncope is unknown.* It is a leading cause of emergency room visits. Syncope is difficult to diagnose as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques. Continued from page 1 Reveal® DX and Reveal® XT Monitor the Heart for Up to Three Years, Helping Physicians with Identifying the Cause of Unexplained Fainting and Keeping Watch on Arrhythmias T Pat Mackin, president of the Cardiac Rhythm Disease Management business at Medtronic, said “The Reveal monitors provide diagnostics and monitoring that can offer physicians a view into their patients’ conditions even when they’re not present.” Placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure, the Reveal DX monitor records important cardiac rhythm data, which may help a physician to diagnose the patient so the appropriate treatment can be undertaken.The device weighs just 15 grams and is approximately the size of a memory stick; unlike a pacemaker or implantable cardioverterdefibrillator, there are no leads that extend from the device into the heart’s chamber(s). To store an electrocardiogram at the time of an episode, a patient places a hand-held, pager-sized activator over the device and presses a button. Later a physician analyzes the stored information and determines if the episode was caused by an abnormal heart rhythm. * E.S. Soteriades et al. N Engl J Med 2002; 347(12):878-885. Signalife Presence at XIII World Congress on Cardiac Pacing and Electrophysiology ignalife, Inc. announced its presence at the XIII World Congress on Cardiac Pacing and Electrophysiology, which was held December 2-6, 2007 in Rome, Italy.At the Congress, Dr. Muricio Arruda, who has been testing Signalife's wireless Fidelity 400 Intracardiac Monitor at the electrophysiology laboratories of the Cleveland Clinic Heart Center, presented a prototype of the Fidelity 400 Intracardiac Monitor to selected participants.The Signalife Fidelity 400 Intracardiac Monitor applies Signalife's proprietary physiological signal acquisition and amplification technology to read intracardiac signals procured from intracardiac catheter products. An intracardiac catheter is equipped with electrodes that allow the signal to be recorded within the heart, and the catheter data is transmitted to a monitor, which allows the physician to evaluate cardiac function, including arrhythmia.These readings are beneficial in that they measure signals directly from the heart, as opposed to signals read from the surface of the body, as is typical in the ordinary application of heart monitors. The mission of the World Congress of Cardiac Pacing and Electrophysiology is to provide an education forum, underlining evidence-based clinical practices in the field of arrhythmology for clinical cardiologists and electrophysiologists.The Congress also highlights the latest and most advanced topics in invasive electrophysiology and cardiac pacing, giving leading electrophysiologists the opportunity to demonstrate and discuss new S diagnostic and therapeutic strategies. Dr. Budimir Drakulic, Signalife's Chief Technology Officer, commented “We have applied Signalife's patented signal processing technology to intracardiac signals with the same success realized with ambulatory ECG recordings and are looking forward to further development of this technology. We intend to file this one-of-a-kind intracardiac monitor for FDA approval shortly.” Dr. Lowell Harmison, Signalife's President, states that “this technology application will allow us to get new data concerning a host of electrophysiological changes in the heart that were not impossible to be obtained before. Our electrocardiography technology is opening new opportunities for medical research and clinical findings based on getting a more accurate and definitive ECG signal in the catheterization lab and surgery as well as under conditions of stress and a spectrum of ambulatory conditions. It is becoming a powerful new tool for cardiac monitoring and for improved cardiac care.” Signalife, Inc. is a life sciences company focused on the monitoring and detection of disease through continuous biomedical signal monitoring. Signalife uses its patented signal technology to design and develop medical devices that simplify and reduce the costs of diagnostic testing and patient monitoring in an ambulatory setting.
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