Transoma Medical Receives FDA Marketing Clearance for Sleuth(TM) Implantable ECG Monitoring System.

Wireless Remote ECG Monitoring System Enables Physicians to Diagnose Unexplained Fainting in Patients at Home and Work

First Truly Wireless Implantable Monitoring System for Patients Represents a Significant Technology Advancement

ST. PAUL, Minn. -- 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 Sleuth(TM) 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."

How Sleuth Works

As a complete, wireless system, Sleuth offers several advantages over other currently available ambulatory monitoring products. The Sleuth ECG Monitoring System includes the High Definition Implantable Loop Recorder (HD-ILR), the Personal Diagnostic Manager, the Base Station and a Monitoring Center staffed 24/7.

* The High Definition Implantable Loop Recorder is a small, thin device, about the size of a 50-cent piece (or the size of the smallest pacemakers), which continuously monitors the electrical activity of the heart, the ECG. The HD-ILR is implanted under the skin during a brief, simple, outpatient procedure. Due to the infrequent nature of syncope, longer term monitoring can be important. Under typical conditions, the HD-ILR is capable of monitoring ECG data for more than two years.

* The Personal Diagnostic Manager is a hand-held, multipurpose device that automatically retrieves and stores relevant ECG data from the HD-ILR, securely relays the information to the monitoring center, and also is used by the physician to program the HD-ILR. Data are collected in two ways:

-- Patients who feel faint can press a symptom button which
tells the system to store the patient's ECG strip during
the time of the fainting spell.

-- The system automatically captures and stores the ECG strip
when the patient's heart rate is above or below physician
programmed limits.

* At the third party Monitoring Center, certified cardiac technicians review the patient's ECG data and provide information to the physician to aid in the diagnosis. Physicians can access this information via a secure Web portal, and have the reports faxed, mailed or e-mailed to them as they prefer. If the cardiac technician observes a particularly concerning arrhythmia, the patient's physician will be contacted immediately.

Significant advantages for patients and physicians are that the Sleuth ECG Monitoring System is truly wireless, and reliably gathers high-quality ECGs as the patient goes about normal everyday activities. "With the Sleuth system, I will receive a report with detailed analysis and relevant ECG data within 24 hours - even if my patient is unaware that an ECG-related episode has occurred," noted Dr. David G. Benditt, professor of medicine and co-director, Cardiac Arrhythmia and Syncope Center at University of Minnesota Medical Center 

Because of the device's wireless capability, ECGs can be captured automatically and forwarded to the Monitoring Center without patient involvement, minimizing patient compliance issues typical of many other remote monitoring systems. Monitoring Center technicians review the data for the physician daily. Patients and physicians no longer need to wait for a periodically scheduled office visit, typically every three months, to obtain important diagnostic information.

About Cardiovascular Syncope

Syncope caused by a cardiac condition can be especially challenging to diagnose because abnormal heart activity may be infrequent or not apparent to the patient. Left undiagnosed and untreated, cardiac syncope can lead to injuries, accidents and death. Conditions causing cardiac syncope include heart attack, heart failure, rhythm disturbances, obstructed blood flow and low blood pressure. With unexplained syncope, many patients need to modify their daily activities significantly, e.g., stop driving or give up a job, impacting quality of life. For additional information regarding syncope, please visit the following website: www.stars.org.uk.

About Transoma Medical

Transoma Medical, Inc., headquartered in St. Paul, Minnesota, is a medical technology company engaged in developing, manufacturing and distributing implantable, subcutaneous, wireless diagnostic and monitoring products. Transoma is focused on two distinct markets - the chronic cardiovascular disease (CVD) market, through its Patient Management Device (PMD) division, and the biomedical research market, through its Data Sciences International (DSI) division.

Transoma's PMD division is focused on developing implantable, ambulatory monitoring systems that provide physicians with vital signs information that is important to accurately diagnose various forms of CVD, and to optimize drug, interventional, surgical and device treatment alternatives. Transoma's DSI division is the leading supplier of wireless, physiologic monitoring equipment and a significant supplier of related data acquisition and analysis products used in biomedical research, including in preclinical drug discovery and development.

For more information, visit the company's Web site at www.transomamedical.com.