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Columbus, Ohio Patients Among First in United States to Receive the Sleuth(TM) Wireless Remote Implantable ECG Monitoring System

Posted on: Thursday, 17 January 2008, 12:00 CST

Patients in the Columbus, Ohio area are among the first in the nation to have been implanted with the Sleuth ECG Monitoring System, the first wireless, implantable system for long-term monitoring of ECG (electrocardiogram) data. Patients who suffer from unexplained syncope, the medical term for fainting, now have a new option for obtaining accurate, timely diagnostic data to assist with the evaluation of cardiac arrhythmias and other serious conditions which may be causing the problem. Sleuth implantation procedures have been performed by Dr. Emile Daoud and Dr. John Hummel, both at The Ohio State University Medical Center in Columbus. Transoma Medical, Inc. manufactures the Sleuth system, which received FDA marketing clearance in October 2007.

"Patients who experience unexplained syncope are often forced to make significant life adjustments with their careers, families and driving because episodes are unpredictable and infrequent," said Dr. Daoud. "Since arrhythmias are often the underlying cause of syncope, it's important to have advanced but simple and reliable tools to facilitate an accurate and prompt diagnosis. The Sleuth implantable recorder and the wireless communication system provide excellent recording fidelity and ease of transmission of ECG data that is continuously monitored and stored. Also, I can select the arrhythmia detection parameters, and the telemetry tracings are promptly sent in a user-friendly report, making it easy for me and my staff to care for our patients."

The risk of 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. Syncope can be caused by a variety of conditions, including metabolic disorders, neurological conditions, emotional distress or cardiovascular conditions. However, for approximately one-third of all patients who faint, a cause cannot be identified with standard testing.

Syncope caused by a cardiovascular condition can be especially challenging to diagnose because abnormal heart activity may be infrequent or not apparent to the patient. Conditions causing cardiovascular 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 Web site: www.stars-us.org.

The Sleuth system is a thin medical device about the size of a 50-cent piece (or the size of the smallest pacemakers) that is placed under the skin near the shoulder. The device continuously gathers ECG data, and then automatically and regularly forwards it to a monitoring center operated by Mednet Healthcare Technologies Inc. Certified cardiac technicians triage the data and send reports of relevant cardiac event data to the physician. A significant advantage for patients and physicians is that the Sleuth system is wireless, and technicians at the monitoring center constantly review the data for irregularities. Patients and physicians no longer need to wait for periodically scheduled office visits, typically every three months, to obtain diagnostic data.

"We are very excited to see physicians adopt our Sleuth system," said Brian Brockway, Transoma Medical chairman and chief executive officer. "Sleuth is based on more than two decades of experience with our remote wireless diagnostic technology, and we are delighted to make a clinical product available to physicians and their patients. Our system is designed to provide accurate, immediate diagnostic data for evaluating cardiac arrhythmias and other serious conditions that can lead to infrequent, unexplained fainting."

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.

Source: Business Wire

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