Transoma Medical Receives FDA Marketing Clearance for Sleuth Implantable ECG Monitoring System

October 01, 2007

Wireless System Transmits Patient’s ECG Data from Home to Physician's Office for Diagnosis of Cardiac Arrhythmias

Cardiac Arrhythmias can be Serious and Cause Syncope (Fainting)

Transoma Medical, the leader in implantable wireless monitoring systems for biomedical research, announced that it has received Food and Drug Administration 510(k) marketing clearance for its SleuthTM Electrocardiogram Monitoring System, the first wireless, implantable heart monitor for human applications. Sleuth monitors heart activity 24/7 to provide accurate, timely diagnostic data for evaluating cardiac arrhythmias and other serious conditions, which often lead to infrequent, unexplained syncope (fainting).

“We are pleased to announce FDA marketing clearance for the Sleuth system,” said Brian Brockway, Transoma Medical chairman and chief executive officer. “This is our first clinical product and is based on more than 20 years of experience with our remote wireless monitoring technology platform in biomedical research. Sleuth is a new tool designed to provide physicians with timely and accurate ECG data, and to lead to a quicker diagnosis for the significant number of patients suffering from unexplained syncope. A quicker diagnosis may mean patients are spared unnecessary testing, limitations on daily activities and injuries from falling – and receive appropriate therapy in a more timely fashion.”

The risk of cardiac syncope increases with age and is becoming more common as the population ages. In the United States, syncope accounts for 3 percent of emergency room visits and 6 percent of hospital admissions. Approximately 90 percent of people who faint have cardiovascular syncope, i.e., syncope caused by a cardiovascular condition.

“An estimated 20 to 50 percent of all adults will have a syncope event at some point,” said Dr. Andrew Krahn, director of the Arrhythmia Monitoring Unit, London Health Sciences Centre University Hospital in London, Ontario, Canada. “Certain cardiac conditions that occur infrequently, including those that cause syncope, are particularly challenging to diagnose. This remote monitoring system will be an important advancement in technology to monitor and improve the care of cardiac patients.”

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