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University of Michigan to Compare Effectiveness of Cardiac
Science Powerheart(R) CRM(TM) Bedside Monitor-Defibrillator With Traditional
'Code Blue' In-Hospital Emergency Response Protocol
Poor In-Hospital Cardiac Arrest Mortality Rates Prompt New Clinical Study to
Support New Standard of Care
IRVINE, Calif., March 24 /PRNewswire-FirstCall/ -- Cardiac Science Inc.
(NASDAQ:DFIB) announced today that physicians at the University of Michigan
Cardiovascular Center have launched a prospective study designed to assess the
effectiveness of the Company's patented fully-automatic hospital bedside
monitor-defibrillator, the Powerheart(R) Cardiac Rhythm Module(TM) (CRM(TM)),
against the traditional hospital "code blue" emergency response protocol. The
CRM device is designed to continuously monitor at-risk cardiac patients around
the clock and, when clinically appropriate, to deliver a potentially
life-saving defibrillation shock without the need to wait for intervention by a
nurse or physician.
The two-phase study is being led by Kim A. Eagle, M.D., Albion Walter Hewlett
Professor of Internal Medicine, Chief of Clinical Cardiology, and Clinical
Director of the University of Michigan Cardiovascular Center. Other published
studies suggest that tens of thousands of patients suffer sudden cardiac arrest
(SCA) in acute care hospitals each year and that despite advances in care,
mortality from these cardiac arrests exceeds 75 percent.
Dr. Eagle said that the current resuscitation approaches employed by hospitals
for patients who suffer life-threatening arrhythmias is often ineffective, and
it is incumbent on the medical community to closely study technology solutions
that have the possibility of proactively protecting at-risk cardiac patients.
"Approaches to the management of sudden cardiac death in hospitals have changed
surprisingly little over the past several decades, while at the same time,
remarkably rapid response to this form of heart disease has become commonplace
on airlines and in other public places," Dr. Eagle said. "Our clinical study
will attempt to validate our hypothesis that bedside monitoring with automatic
defibrillation is economically feasible and clinically effective in the
hospital environment. If proven, it could result in thousands of saved lives
per year and a revision in that standard of care for at-risk cardiac patients."
The study will take place in the 10-bed Cardiac Intensive Care Unit (CICU) at
the University of Michigan's University Hospital, where 42 cardiac arrests
occurred in a recent one-year period.
During Phase 1 of the study, defibrillation therapy in the CICU will continue
to be administered manually under the guidance of a health care provider, per
traditional hospital "code blue" protocols. Time-to-first defibrillation shock
from the onset of the life-threatening ventricular tachyarrhythmias will be
recorded, as will patient outcomes. During Phase 2, all patients in the CICU
will be pre-attached to the Powerheart CRM operating in the fully automatic
mode and will receive automatic defibrillation therapy without human
intervention. The objective of the study will be to compare and contrast the
response times and patient outcomes using current methodology against the
Powerheart CRM.
Current scientific literature reports that response times in hospitals are
measured in minutes and are highly variable depending on staffing levels and
time of day under the traditional "code blue" system. Typically less than 25
percent of patients who suffer SCA during their hospitalization survive to
discharge from the hospital.
Three additional clinical studies are currently underway to determine both
clinical efficacy and cost-effectiveness of bedside CRM monitoring at other
U.S. and international hospitals, including:
* An economic and safety effectiveness study being performed at New York
Methodist Hospital under the direction of Dr. Charles E. Oribabor,
Director, Cardiac Surgery ICU at that institution;
* On-going clinical and observational study at Maimonides Medical Center
in Brooklyn, NY under the direction of Maimonides Director of Clinical
Cardiology, Gerald Hollander M.D. Based on early positive results,
the hospital elected to deploy more than 100 Powerheart CRM devices
and has been accumulating data for more than two years and;
* An outcomes study under the lead of Antonio Martinez-Rubio, M.D. in
the Cardiology department at the Hospital de Sabadell in
Barcelona, Spain.
Past CRM Studies Reported in the Clinical Press
In November 2004, a study published in the Journal Resuscitation authored by
Henry Cusnir, M.D., et al, was conducted at Maimonides Medical Center in
Brooklyn, N.Y. The study looked at staff response times to simulated cardiac
arrest in monitored wards as compared to the Powerheart response in its fully-
automatic mode. Staff verses Powerheart CRM response time was on average
nearly 3 minutes verses 38 seconds.
In October 2004, a study published in the Journal Resuscitation and authored by
Andre Moreira Bento, M.D., et al, was conducted principally at the Instituto do
Corocao, University of Sao Paulo Medical School in Sao Paulo, Brazil. The
study monitored 55 cardiac patients located in special monitoring wards.
During approximately 1,300 hours of monitoring, 18 episodes of life-threatening
rhythm events were documented that required treatment through defibrillation.
The mean response time to defibrillation shock delivered automatically by the
Powerheart CRM was 33.4 seconds and the therapy was successful in converting
the patient to a normal heart rhythm 94.4 percent of the time on the first
shock (17/18) and 100 percent on the second shock (1/1). There were no patient
complications reported.
In February 2003, a European study authored by Antonio Martinez-Rubio, M.D. et
al, was published in the Journal of the American College of Cardiology. The
117-patient study was conducted at 10 European medical centers in Germany,
Spain, Italy and Finland. The patients included 51 at risk cardiac patients
located in special monitoring wards (intensive or coronary care units or in an
emergency room), and 66 patients who were undergoing electrophysiological
testing or implantation of cardioverter- defibrillators (ICDs) because of
suspected or documented ventricular tachyarrhythmias. During a total of 1,240
hours of testing, 1,988 heart rhythm events were documented and 115 of those
needed treatment through defibrillation. The mean response time was 14.4
seconds and there were no complications reported.
In June 2003, a study published in The American Journal of Cardiology authored
by Thomas Mattioni, M.D., et al, conducted at the Arizona Heart Institute,
Phoenix, AZ measured the ability of the Powerheart CRM to accurately
discriminate superventricular (SVT) from life-threatening ventricular
tachyarrhythmias (VT) in patients undergoing a conventional electrophysiology
(EP) study in the electrophysiology lab. In a total of 98 patients the
Powerheart CRM correctly identified 122 episodes of SVT for a resultant
sensitivity of 100 percent and a specificity of 94 percent. The authors
concluded that the Powerheart accurately discriminates SVT from VT and is
expected to correctly deliver automatic shocks in the presence of spontaneous
life-threatening arrhythmia and appropriately withhold therapy during SVT.
About the Powerheart(R) Cardiac Rhythm Module(TM) (CRM(TM))
The Powerheart CRM is the only FDA-cleared therapeutic patient monitor that
offers a complete therapeutic monitoring and defibrillation package in a single
device -- continuous cardiac monitoring, synchronized cardioversion,
non-invasive pacing as well as manual, semi-automatic or fully-automatic
defibrillation. Designed for use in medically-supervised environments, the
Powerheart CRM may be used to monitor patients during transport, as an
emergency defibrillator or be prophylactically attached to an at-risk cardiac
patient. Once programmed and attached to the patient via its disposable
electrode pads, the CRM can operate without human intervention. It
continuously monitors a patient's heart, detects the onset of life-threatening
arrhythmias and can automatically deliver defibrillation therapy to patients
suffering from spontaneous life-threatening ventricular tachyarrhythmias
(sudden cardiac arrest).
About Cardiac Science
Cardiac Science develops, manufactures and markets a complete line of
Powerheart(R) brand, automated public access defibrillators (AEDs), and offers
comprehensive AED/CPR training and AED program management services that
facilitate successful deployments. The company makes the Powerheart(R)
CRM(TM), the only FDA-cleared therapeutic patient monitor that instantly and
automatically treats hospitalized cardiac patients who suffer life-threatening
heart rhythms. Cardiac Science also manufactures its AED products on a private
label basis for other leading medical companies such as Nihon Kohden (Japan),
Quinton Cardiology Systems and GE Healthcare. For more information please
visit http://www.cardiacscience.com/ or call 1.949.797.3800.
This news release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995. In addition, from time
to time the company, or its representatives, have made or may make forward
looking statements orally or in writing. The words "estimate," "potential,"
"intended," "expect," "anticipate," "believe," and similar expressions or words
are intended to identify forward looking statements. Such forward-looking
statements include, but are not limited to, the possibility that the
Powerheart(R) CRM(TM) could create a new standard of care for in hospital
cardiac patients. Cardiac Science cautions that these statements are subject
to substantial risks and uncertainties and are qualified by important factors
that could cause actual results to differ materially from those reflected by
the forward-looking statements and should not be relied upon by investors when
making an investment decision. Information on these and other factors is
detailed in the Company's Form 10-K for the year ended December 31, 2004, and
other documents filed by the Company with the Securities and Exchange
Commission. Given these risks and uncertainties, investors are cautioned not
to place undue reliance on such forward-looking statements. The Company does
not undertake any obligation to update any such statements or to publicly
announce the results of any revisions to any such statements to reflect future
events or developments.
CONTACT: Matt Clawson (Investors) Michael D. Gioffredi
Len Hall (Media) Chief Marketing Officer
Allen & Caron Inc. Cardiac Science, Inc.
(949) 474-4300 (949) 797-3800
DATASOURCE: Cardiac Science, Inc.
CONTACT: Matt Clawson (Investors), , or Len Hall
(Media), , both of Allen & Caron Inc., +1-949-474-4300, for
Cardiac Science, Inc.; or Michael D. Gioffredi, Chief Marketing Officer of
Cardiac Science, Inc., +1-949-797-3800,
Web site: http://www.cardiacscience.com/