Healthcare Industry News: cardiac monitor
News Release - June 4, 2008
LifeWatch Corp. Parent Company, Card Guard AG Receives Full FDA Clearance for Next-Generation LifeStar ACT III Platinum System510(k)-cleared, 3-lead ECG system enabling unique real-time monitoring features
Technology provides enhanced real time ambulatory cardiac telemetry capabilities with potential for broader diagnostic applications
Expected US market launch in Q4 of 2008
CHICAGO--(HSMN NewsFeed)--LifeWatch Corp.: Card Guard AG (SWX: CARDG ), the parent company of LifeWatch Corp. announced yesterday that the company has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) for its next-generation LifeStar ACT III Platinum system (CG-6108 FDA Clearance Number K081257 with a DSI product code that defines real-time arrhythmia detection and alarm, including ST-segment measurement and alarm to meet the US Payor and Medicare reimbursement requirements). The LifeStar ACT III Platinum system, based on the existing LifeStar ACT I (1-lead ECG) system, features enhanced heart arrhythmia detection capabilities thanks to its unique 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 can automatically detect and send heart rhythm abnormalities to a LifeWatch monitoring call centre 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.
Expanding the ambulatory cardiac telemetry market
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. 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. The American Heart Association1 reports that 9.1 million individuals suffered from Angina Pectoris in the US in 2005, and a further 4 to 5 million may have ‘silent ischemic’ episodes, that are without symptoms or knowledge of their condition.
“Real-time outpatient cardiac monitoring using this unique 3-lead configuration can extend the management of these patient conditions which are traditionally monitored in an inpatient setting, and potentially provide more sensitive and specific data for early detection of a worsening condition in patients that are minimally symptomatic,” according to Dr. Harry A. Kopelman, Co-Director of the Cardiac Electrophysiology Laboratory at the Fuqua Heart Center & the Piedmont Heart Institute. Dr. Kopelman is a highly esteemed electrophysiologist who has authored and co-authored a number of papers in highly referred publications and serves as the Chairman of the LifeWatch Medical Advisory Board. Biography of Dr. Harry Kopelman
Strengthening the growth pattern
LifeWatch is confident that the LifeStar ACT III Platinum will once again contribute to strengthening the Group’s growth momentum, largely based on the success of its LifeStar ACT systems which today are being used by 50 of the top-ranking US hospitals and medical centers.
LifeWatch, the US-based subsidiary of Card Guard, has exclusive distribution rights for LifeStar ACT I and LifeStar ACT III Platinum systems in the US until 2011. All of the necessary regulatory clearances are in place to market LifeStar ACT systems, which offer clients a comprehensive Ambulatory Cardiac Telemetry service. LifeWatch expects to launch the LifeStar ACT III Platinum system in the 4th quarter of this year.
1. Heart Disease and Stroke Statistics — 2008 Update, American Heart Association
About LifeWatch Corp.
LifeWatch Corp., through its operating subsidiaries Lifewatch Services, Inc. and LifeWatch Technologies, Inc. (Instromedix) is an independent provider of ambulatory cardiac monitoring services and a manufacturer and distributor of ambulatory cardiac and vital signs monitoring devices in the United States. Its current services are used by physicians primarily to monitor patients who are suspected of having heart rhythm disorders, or cardiac arrhythmias, and its products are used by itself and by others in connection with providing cardiac monitoring services. LifeWatch is a wholly owned subsidiary of Card Guard AG, a leading healthcare technology and solutions provider listed on the Swiss Stock Exchange (CARDG). For more information, visit: www.lifewatch.com.
Source: LifeWatch Corp
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