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Transoma Medical Receives FDA Marketing Clearance for Sleuth AT Implantable Cardiac Monitoring System


2/12/2009 7:45:13 AM

ST. PAUL, Minn.--(BUSINESS WIRE)--Transoma Medical, manufacturer of Sleuth, the first wireless, automated implantable cardiac monitoring system has now 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.

With Sleuth AT, physicians can now 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, William Wikoff Smith Chair in CV Research at the Lankenau Institute in Wynnewood, PA. “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.”

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.

“We are pleased to announce FDA marketing clearance of the Sleuth AT system,” said Nestor Jaramillo, Transoma Medical Vice President of Sales and Marketing. “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.”

How Sleuth AT Works As a complete, remote and automated system, Sleuth AT offers several advantages over other currently available implantable monitoring products. The 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, a leader in cardiac monitoring since 1981.

* The Implantable Cardiac Monitor 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 cardiac monitor is implanted under the skin during a brief, simple, outpatient procedure. * The Personal Diagnostic Manager (PDM) is a hand-held, multipurpose device that automatically retrieves and stores relevant ECG data from the implanted cardiac monitor, securely relays the information to the base station and then to the monitoring center. The PDM is also used by the physician to program the implanted cardiac monitor. Data are collected in three ways: o Patients who experience symptoms, such as lightheadedness, can press a button on the PDM which tells the system to store the patient’s ECG strip during the time of the symptom. o The system automatically captures and stores the ECG strip when the patient’s heart rate is above or below physician-programmed limits. o The system can be programmed to capture regular ECG strips every 4 hours, 15 minutes or 7.5 minutes * At the third-party Monitoring Center, certified cardiac technicians review the patient’s ECG data and provide information to the physician to aid in diagnosis and ongoing treatment. Physicians can access this information via a secure Web portal, and have the reports faxed 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. About Transoma Medical Transoma Medical, Inc., headquartered in St. Paul, Minnesota, is a medical technology company engaged in developing, manufacturing and distributing implantable, wireless diagnostic and monitoring products. Transoma is focused on monitoring systems that provide physicians with vital signs information important to accurately diagnose and monitor various forms of cardiovascular disease, and to optimize drug, interventional, surgical and device treatment alternatives. For more information, visit the company’s Web site at www.transomamedical.com.

Contact:

Transoma Medical, Inc. Brian Brockway, 651-481-7444 bbrockway@transomamedical.com or Padilla Speer Beardsley: Nancy A. Johnson, 612-455-1745 njohnson@psbpr.com or Nick Banovetz, 612-455-1705 nbanovetz@psbpr.com

Source: Transoma Medical, Inc.


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