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Transoma Medical Announces FDA Marketing Clearance For Its New Data Review Feature On Sleuth AT

Transoma Medical, Inc. has received FDA 510(k) marketing clearance for its new Data Review feature on Sleuth AT. The Data Review feature allows any clinician to easily access up to 99 events stored on the patient’s Personal Diagnostic Manager (PDM). The PDM is a handheld device that retrieves and stores ECG data from the implanted device prior to automatic transmission to the 24/7 monitoring center. Each stored ECG strip is labeled with the time and date of the cardiac event making it easier for clinicians to correlate symptoms with rhythms.

“Instant access to a patient’s ECG data on the mobile handheld device is a clinically valuable tool in urgent situations, such as when the patient presents in the emergency room,” said Dr. Asim Yunus, an electrophysiologist with Michigan Cardiovascular Institute in Saginaw, Mich. “Transoma continues to advance cardiac monitoring technology with their devices. The Sleuth systems already provided information much faster and more efficiently than other implantable monitoring options. Now, with Data Review, we don’t even have to wait for the automatic downloads to the monitoring center because the events are right there on the handheld device. This kind of access to information has never been available before.”

As a complete, remote and automated system, Sleuth AT offers several advantages over other available implantable monitoring products. The system includes a small implanted device that incorporates the most sensitive arrhythmia detector of any ICM on the market. Not only does Sleuth AT capture ECG strips containing arrhythmias automatically, it also allows the patient to capture data by pressing a button on the handheld PDM after experiencing a symptom. All data captured by the implanted device is automatically transferred to the PDM, providing an additional 10.5 hours of ECG storage. Data stored on the PDM is automatically transmitted to a 24/7 monitoring center where certified cardiac technicians review the data and alert clinicians to clinically-significant events, providing a high degree of specificity. And now, with Data Review, ECG recordings that have not yet been transmitted to the monitoring center can be accessed directly on the handheld PDM.

“As a device clinic coordinator, it is not uncommon for me to manage data on 2,000 or more patients at a given time from a variety of cardiac monitoring systems,” said Lori Fravel, BSN, CCRN, CCDS, a nurse who supports 10 cardiologists at Mt. Carmel Columbus Cardiology Consultants in Columbus, Ohio. “I have found the Sleuth systems to be extremely efficient because I am only alerted to clinically-significant events and I never have to call the patient to coordinate manual interrogation of his or her device. The setup of the system allows me to get the information I need in a much more streamlined fashion. Now with Sleuth AT, the added benefit of ECG access on the handheld device means any available clinician can view recently captured events without a programmer, even if the patient has been away from home. I am hopeful this will further speed access to critical information.”

“With the addition of the Data Review feature, the Sleuth AT system is designed to be an even better and more accurate diagnostic tool that further enhances efficiency for the practice and simplicity for the patient,” said Nestor Jaramillo, Transoma Medical vice president of sales and marketing. “Our goal is to assure that clinicians have access to the right cardiac information at the right time in the simplest and most efficient manner possible. Providing the right information to the physician can lead to faster diagnosis and selection of the right therapeutic regimen for the patient. Everyone can benefit. At Transoma Medical, we believe better treatment starts with better information.”