FDA Clears Medtronic’s New Insertable Cardiac Monitors
December 17, 2007 - Medtronic Inc. today announced it received FDA clearance of the Reveal DX and Reveal XT, new insertable cardiac monitors (ICMs) designed to provide diagnostic and monitoring insights to cardiologists managing their patients with syncope (fainting) or abnormal heart rhythms, including ventricular tachyarrhythmias (VT), fast ventricular tachyarrhythmias (FVT), bradyarrhythmias and asystole.
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, according to a study published in the New England Journal of Medicine (E.S. Soteriades et al. N Eng J Med. 2002; 347 (12):878-885.). 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.
Placed just under the skin of the chest area using local anesthesia during an 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 15 grams and is approximately the size of a memory stick. Unlike a pacemaker or implantable cardioverter-defibrillator, there are no leads that extend from the device into the heart’s chambers. 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 and the Reveal XT will follow.
For more information: www.medtronic.com