FDA okays new monitoring device
Posted on February 11th, 2009 – 6:41 PMBy Thomas Lee
The Food and Drug Administration approved a second generation device developed by Transoma Medical Inc. of Arden Hills that allows doctors to remotely monitor the heart rhythms of patients who suffer from sudden fainting.
The updated device, called Sleuth AT, can now capture electrocardiogram (ECG) strips, which measures the heart’s electrical activity, at more frequent intervals.
“The Transoma Sleuth AT system promises to provide an improved approach,” Dr. Peter Kowey, Chief of Cardiology for Main Line Health, William Wikoff Smith Chair in CV Research at the Lankenau Institute in Wynnewood, PA, said in a statement. “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 an extremely common problem for my patients and significantly increases their risk of stroke,” continued Dr. Kowey. “In fact, the need for long-term monitoring of AF patients was reinforced last month at the 2009 Boston AF Symposium by both surgeons and electrophysiologists. Although some therapies have been shown to control these arrhythmias, at least temporarily, until now there has not been a good way to monitor continued success. With the Sleuth AT system, physicians can be notified by the monitoring center if the patient’s AF has returned. This is important because recurrence of AF happens without symptoms as often as 50 to 70 percent of the time.”



