Transoma Medical, out of St. Paul, Minnesota, has received FDA approval for the company’s new wireless implantable cardiac monitor. The Sleuth AT™ can wirelessly communicate with a personal device carried in a pocket or purse, or with a home base station that can automatically contact patient’s physician if an abnormal rhythm is detected.
Here’s a more complete description of the system from Transoma:
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:
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. The system automatically captures and stores the ECG strip when the patient’s heart rate is above or below physician-programmed limits. 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.
Press release: Transoma Medical Receives FDA Marketing Clearance For Sleuth AT™ Implantable Cardiac Monitoring System
Flashback: Sleuth™ Wireless Electrocardiogram Monitoring System