Implantable Cardiac Monitor Receives FDA Nod


February 5, 2008

Medtronic Inc. received FDA clearance of the Reveal DX Insertable Cardiac Monitor (ICM) 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 monitor is placed just under the skin of the chest area using local anesthesia during an 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, which weighs 15 grams, 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. 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.

February 2008