Implantable Cardiac Monitors Receive FDA Nod


December 14, 2007

December 14, 2007 - Medtronic Inc. announced FDA clearance of Reveal DX and Reveal XT Insertable Cardiac Monitors (ICMs) designed to help physicians identify the cause of unexplained fainting or abnormal heart rhythms, including ventricular tachyarrhythmias (VT), fast ventricular tachyarrhythmias (FVT), bradyarrhythmias and asystole.

The Reveal DX reportedly 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. Syncope is difficult to diagnose, as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques.

The Reveal DX monitor is placed just under the skin of the chest area using local anesthesia during a simple outpatient procedure and 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 (ECG) 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.

The Reveal DX will be commercially available in the U.S. beginning next week; the Reveal XT will follow.

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