News | June 03, 2008

New ECG Monitor Extends its Leads to Three

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

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Use of traditional Holter monitor leads can be an issue for patient compliance and comfort. The newer generation ambulatory cardiac monitors use an adhesive patch that sticks directly on the patient's chest and allows them to shower and go about daily activities without a belt mounted monitor or leads getting in the way. This is especially important for longer term monitoring of seven days or longer.

Use of traditional Holter monitor leads can be an issue for patient compliance and comfort. The newer generation ambulatory cardiac monitors use a small, adhesive patch that sticks directly on the patient's chest and allows them to shower and go about daily activities without a belt mounted monitor or leads getting in the way. This is especially important for longer term monitoring of seven days or longer. 

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