June 4, 2008 - Card Guard AG has received 510(k) clearance from the FDA for its next-generation LifeStar ACT III Platinum system with 3-lead ECG functionality, designed to enable the tracking of vital heart rhythm information in real-time.
The device’s DSI product code defines real-time arrhythmia detection and alarm, including ST-segment measurement and alarm to meet the U.S. Payor and Medicare reimbursement requirements.
The LifeStar ACT III Platinum system, based on the existing LifeStar ACT I (1-lead ECG) system, features a reportedly enhanced heart arrhythmia detection capabilities thanks to its 3-lead ECG functionality. Like the successful LifeStar ACT I system, the new 3-lead version offers the same full auto-detect and auto-send device functionality and therefore does not require any patient interaction.
The LifeStar ACT system is said to automatically detect and send heart rhythm abnormalities to a LifeWatch monitoring call center that is staffed 24 hours/7 days a week/365 days a year by specialized cardiac technicians who can immediately interpret the data and initiate any necessary next steps. LifeStar ACT devices can enhance the diagnostic yields, and be of life-saving value.
The LifeStar ACT III Platinum’s ability to place 3 ECG leads comfortably on a patient’s chest enhances the ability to obtain vital heart rhythm information, which typically requires the use of 12-lead ECGs in a stationary setting.
According to the company, the ACT III Platinum platform has the potential to expand the market by extending to the outpatient setting real-time ambulatory cardiac telemetry. This will enable monitoring of additional patient conditions, such as myocardial ischemia, the cause of angina pectoris.
For more information: www.lifewatch.com