04.06.2008 11:00:00
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LifeWatch Corp. Parent Company, Card Guard AG Receives Full FDA Clearance for Next-Generation LifeStar ACT III Platinum System
LifeWatch Corp.: 510(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
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.
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