This newly FDA 510(k)’ed device from St. Paul, MN company Transoma Medical is designed to wirelessly monitor a patient’s ECG, for possible diagnosis of arrhythmias and prevention of syncopal episodes.
The company, that just filed for $75 mln IPO, provides details about its flagship product:
As a complete, wireless system, Sleuth offers several advantages over other currently available ambulatory monitoring products. The Sleuth ECG Monitoring System includes the High Definition Implantable Loop Recorder (HD-ILR), the Personal Diagnostic Manager, the Base Station and a Monitoring Center staffed 24/7.
The High Definition Implantable Loop Recorder 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 HD-ILR is implanted under the skin during a brief, simple, outpatient procedure. Due to the infrequent nature of syncope, longer term monitoring can be important. Under typical conditions, the HD-ILR is capable of monitoring ECG data for more than two years. The Personal Diagnostic Manager is a hand-held, multipurpose device that automatically retrieves and stores relevant ECG data from the HD-ILR, securely relays the information to the monitoring center, and also is used by the physician to program the HD-ILR. Data are collected in two ways:
— Patients who feel faint can press a symptom button which tells the system to store the patient’s ECG strip during the time of the fainting spell.
–The system automatically captures and stores the ECG strip when the patient’s heart rate is above or below physician programmed limits.
At the third party Monitoring Center, certified cardiac technicians review the patient’s ECG data and provide information to the physician to aid in the diagnosis. Physicians can access this information via a secure Web portal, and have the reports faxed, mailed 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.
Significant advantages for patients and physicians are that the Sleuth ECG Monitoring System is truly wireless, and reliably gathers high-quality ECGs as the patient goes about normal everyday activities. “With the Sleuth system, I will receive a report with detailed analysis and relevant ECG data within 24 hours – even if my patient is unaware that an ECG-related episode has occurred,” noted Dr. David G. Benditt, professor of medicine and co-director, Cardiac Arrhythmia and Syncope Center at University of Minnesota Medical Center.
Because of the device’s wireless capability, ECGs can be captured automatically and forwarded to the Monitoring Center without patient involvement, minimizing patient compliance issues typical of many other remote monitoring systems. Monitoring Center technicians review the data for the physician daily. Patients and physicians no longer need to wait for a periodically scheduled office visit, typically every three months, to obtain important diagnostic information.
Product page: Sleuth™ Wireless Electrocardiogram Monitoring System …
Press release: Transoma Medical Receives FDA Marketing Clearance for Sleuth(TM) Implantable ECG Monitoring System (.pdf)