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Medtronic’s new Implantable Cardiac Monitors receive US FDA clearance

Medtronic : 13 December, 2007  (New Product)
Medtronic’s new Insertable Cardiac Monitors (ICMs), Reveal DX and Reveal XT, have received US Food and Drug Administration (FDA) clearance.
The new ICMs offer 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 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 USA 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 (Ref 1). Syncop 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.

“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 anaesthesia 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 (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 analyses the stored information and determines if the episode was caused by an abnormal heart rhythm.

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

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