Healthcare Industry News: remote monitoring
News Release - October 29, 2007
First U.S. Patients Receive Transoma Medical's Sleuth(TM) Wireless Remote Implantable ECG Monitoring System
Captures ECG Data for Diagnosing Cardiac Arrhythmias Behind Unexplained and Infrequent FaintingST. PAUL, Minn.--(HSMN NewsFeed)--Transoma Medical, Inc., the leader in implantable wireless monitoring systems for biomedical research, announced that the first U.S. patients have received its Sleuth Implantable ECG (electrocardiogram) Monitoring System. The first implant was performed last week by Dr. John Hummel at the Ohio State University Medical Center in Columbus. Additional procedures were performed by Dr. Randy Lieberman, electrophysiologist at Heart Care Cardiology in Detroit; and Dr. Michael Gold, chief of cardiology at the Medical University of South Carolina in Charleston. The company received 510(k) marketing clearance from the FDA on October 1, 2007, and a phased U.S. launch is under way to introduce the product to physicians for their patients who experience infrequent, unexplained syncope (fainting).
“We based the Sleuth ECG system on our implantable wireless remote monitoring technology platform that has played an important role in the development of pharmaceuticals and medical devices for more than two decades,” said Brian Brockway, Transoma Medical chairman and chief executive officer. “Now, we are pleased to make our technology available to physicians and their patients, to provide clinically relevant, timely diagnostic data for evaluating cardiac arrhythmias and other serious conditions that can lead to infrequent, unexplained fainting.”
“We are very excited about the first implantations of our Sleuth ECG System since receiving marketing clearance from the FDA,” added Nestor Jaramillo, Transoma Medical vice president of sales and marketing. “The Sleuth ECG System is our first commercialized product for 24/7 monitoring of patients’ hearts, at home and away, and future generations are currently under development.”
The Sleuth Implantable ECG Monitoring System, a thin medical device about the size of a 50-cent piece (or the size of the smallest pacemakers), 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. There, certified cardiac technicians review the patient’s ECG information and send reports of relevant cardiac event data to the physician. Significant advantages for patients and physicians are that the Sleuth ECG System is wireless, and technicians at the monitoring center automatically receive patient data thereby allowing them to frequently review the information for irregularities. By choosing the Sleuth ECG System, patients and physicians no longer need to wait for periodically scheduled office visits, typically every three months, to obtain diagnostic data.
“The Sleuth system is a new advance in obtaining accurate, thorough ECG data for diagnosing unexplained fainting,” said Dr. Hummel. “The wireless system and long data storage cycle will provide me with the ECG information to potentially diagnose unexplained events accurately, regardless of the patient’s activities or whereabouts.”
Dr. Lieberman added, “The Sleuth system is remarkably simple to use, beginning with the minimally invasive procedure to implant the device, easy programming for me and hassle-free monitoring for patients. The compact antenna, unique to Sleuth, gives me greater flexibility in selecting the implant site.”
“With Sleuth, I can program the Personal Diagnostic Manager to specify the ECG data I want to see, and my patient can use the same device to indicate when symptoms occur,” noted Dr. Gold. “The 10-plus hours of data storage reduce the chance that diagnostically important cardiac events will be overwritten.”
About Cardiovascular Syncope
The risk of syncope increases with age and is becoming more common as the population ages. Syncope accounted for 3 percent of emergency room visits and 6 percent of hospital admissions in the United States in 2004. Syncope can be caused by a variety of conditions, including metabolic disorders, neurological conditions, emotional distress or cardiovascular conditions. Cardiovascular syncope can be especially challenging to diagnose because abnormal heart activity may be infrequent or not apparent to the patient. Conditions causing cardiovascular syncope include prior heart attack, heart failure, rhythm disturbances, obstructed blood flow and low blood pressure.
For approximately one-third of all patients who faint, a cause cannot be identified with common tests such as echocardiograms and tilt-table tests. With unexplained syncope, many patients are forced to significantly modify their daily activities, e.g., stop driving or give up a job, thereby impacting quality of life. For additional information regarding syncope, please visit the following Web site: www.stars-us.org.
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: Transoma Medical
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