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Medtronic Implantable Cardiac Monitors Give Physicians Valuable Insights into Heart Rhythms.


Reveal([R]) DX and Reveal([R]) XT Monitor the Heart for Up to Three Years, Helping Physicians with Identifying the Cause of Unexplained Fainting and Keeping Watch on Arrhythmias

MINNEAPOLIS -- Medtronic, Inc. (NYSE NYSE

See: New York Stock Exchange
:MDT) today announced the U.S. Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) clearance of the Reveal([R]) DX and Reveal([R]) XT, new Insertable Cardiac Monitors (ICMs) that offer unique diagnostic and monitoring insights to cardiologists managing their patients with syncope syncope

Effect of temporary impairment of blood circulation to a part of the body. It is often used as a synonym for fainting, which is loss of consciousness due to inadequate blood flow to the brain.
 (fainting) or abnormal heart rhythms, including ventricular tachyarrhythmias (VT), fast ventricular tachyarrhythmias (FVT), bradyarrhythmias and asystole asystole /asys·to·le/ (a-sis´to-le) cardiac standstill or arrest; absence of heartbeat.asystol´ic

a·sys·to·le
n.
The absence of contractions of the heart.
. The new Reveal devices expand on the cardiac monitoring foundation Medtronic began more than 10 years ago with the Reveal[R] and Reveal Plus[R] 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 Sudden Cardiac Death Definition

Sudden cardiac death (SCD) is an unexpected death due to heart problems, which occurs within one hour from the start of any cardiac-related symptoms. SCD is sometimes called cardiac arrest.
. 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 unknown1. It is a leading cause of emergency room visits. Syncope is difficult to diagnose as syncopal syn·co·pal
adj.
Of or relating to syncope.
 episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques.

"The Reveal DX showcases Medtronic's commitment to providing answers to patients with previously unidentified arrhythmias," said Pat Mackin, president of the Cardiac Rhythm Disease Management business at Medtronic. "These patients often have their lives and activities curtailed because of unexplained fainting episodes. 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 cardioverter-defibrillator, there are no leads (tiny wires) that extend from the device into the heart's chamber(s). To store an electrocardiogram electrocardiogram /elec·tro·car·dio·gram/ (-kahr´de-o-gram?) a graphic tracing of the variations in electrical potential caused by the excitation of the heart muscle and detected at the body surface.  (ECG ECG electrocardiogram.

ECG
abbr.
1. electrocardiogram

2. electrocardiograph


ECG
Also called an electrocardiogram, it records the electrical activity of the heart.
) 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.

1E.S. Soteriades et al. N Eng J Med. 2002; 347 (12):878-885

About Arrhythmias

Arrhythmias are simply irregular heart rhythms in the heart's atria Atria
The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps.
 (upper chambers) or ventricles Ventricles
The two chambers of the heart that are involved in pumping blood. The right ventricle pumps blood into the lungs to receive oxygen. The left ventricle pumps blood into the circulation of the body to deliver oxygen to all of the body's organs and tissues.
 (lower chambers). They can be dangerously fast heart rhythms, known as tachycardia or tachyarrhyhmias; dangerously slow rhythms, known as bradycardia bradycardia: see arrhythmia.  or bradyarrhythmias; fibrillation, where the heart quivers instead of pumping blood effectively to the body; or asystole, which is the absence of electromechanical activity within the heart.

About Medtronic

Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.
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Publication:Business Wire
Date:Dec 12, 2007
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