First U.S. Patient Gets Transoma Medical's Sleuth AT Implantable Cardiac Monitoring System

According to a release, the implant was performed on March 2 by Dr. Troy Rhodes, an electrophysiology fellow under the supervision of Dr. Mahmoud Houmsse at the Ohio State University Medical Center in Columbus.

The company received FDA 510(k) marketing clearance for its product on February 11. A U.S. launch is under way to introduce Sleuth AT to physicians who manage patients with complex arrhythmias as well as patients who experience infrequent, unexplained symptoms such as fainting or palpitations.

"The implant went very well and took only about 15 minutes," reported Dr. Houmsse. "This new system also offers the option of a longer 8 cm antenna which showed very impressive, high-quality ECG signals even before the incision was closed."

Sleuth AT allows physicians 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).

"Transoma's enhanced Sleuth system is an exciting new development for physicians who manage difficult and changing complex arrhythmias such as atrial fibrillation," said Dr. John Hummel, also from the Ohio State University Medical Center. "Although some therapies appear to be curative, one needs to be certain that the benefits are lasting. With Sleuth AT, I can sample 20-second ECG strips as often as every 7.5 minutes and be alerted through the monitoring center of recurrence of these arrhythmias. The Sleuth AT will provide baseline cardiac information prior to a planned AF ablation procedure and will help me monitor for recurrence of AF after the procedure. Regardless of the outcome, the access to long-term monitoring will allow me to manage the patient's need for medications, including anticoagulation therapy."

AF is a 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.

As a complete, remote and automated system, the Sleuth AT Sleuth AT Cardiac Monitoring System includes the Implantable Loop Recorder (ILR), the Personal Diagnostic Manager (PDM), the Base Station and a 24/7 Monitoring Center operated by Medicomp.

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