Transoma Medical has received FDA marketing clearance on its second generation product, Sleuth AT™ (Advanced Trending) Cardiac Monitoring System. The Sleuth products offer physicians the ability to diagnose patients with recurrent, unexplained fainting and abnormal heart rhythms quickly with its virtually unlimited memory capacity and hands-free downloading for the patient, while minimizing paperwork and practice workload.

"We are pleased to announce FDA marketing clearance of the Sleuth AT system," said Nestor Jaramillo, Transoma Medical Vice President of Sales and Marketing, on the company's website. "We are experiencing great success with our first clinical product which was based on more than 20 years of experience with our remote, wireless monitoring technology platform in biomedical research. In addition to providing insight into the cause of unexplained, infrequent symptoms, Sleuth AT is designed to provide physicians with timely and accurate ECG data that could allow them to monitor the efficacy of prescribed therapies."

The new Sleuth AT will allow physicians to choose to program the capture of high-quality ECG (electrocardiogram) strips at frequent intervals, providing a new level of insight into complex arrhythmias which are often asymptomatic and frequently changing. These captured ECG strips are automatically transferred to a 24/7 monitoring center, staffed by Certified Cardiac Technicians, who classify and notify physicians of the presence of a wide variety of cardiac arrhythmias such as ventricular tachycardia, bradycardia, supraventricular tachycardia and atrial fibrillation (AF).
"The Transoma Sleuth AT system promises to provide an improved approach," said Dr. Peter Kowey, Chief of Cardiology for Main Line Health. "The concept of the device, without memory constraints, automatically capturing frequent ECG strips which are then over-read at the monitoring center, may address the limitations and inaccuracies of existing devices used to assess complex arrhythmias such as atrial fibrillation."

AF is the most common cardiac arrhythmia affecting approximately 2.2 million patients in the United States and is increasing in prevalence as the population ages. Presence of AF can lead to two to seven times higher risk of stroke, an increased risk of heart failure or sudden cardiac death, due to inefficient pumping of the heart.

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