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SonoSite, Inc. (Nasdaq:SONO), the world leader in
hand-carried ultrasound, announced today at the 2005 American Heart
Association (AHA) Scientific Sessions that it is initiating a
multi-center study to determine whether the addition of an ultrasound
examination evaluating carotid artery wall thickness (CIMT), performed
in the office setting, will provide a more effective tool for risk
assessment and prevention of cardiovascular disease than current
clinical methods alone.
Over 20 years of clinical research has shown that the thickness
(T) of the two innermost layers of the carotid artery wall, the intima
(I) and media (M), begins to increase before plaque is evident within
the vessel. This increased wall thickness is associated with an
increased risk of cardiovascular disease, the leading cause of
mortality and disability in the United States today.
"IMT addresses the need to identify those patients who are
asymptomatic or have limited risk factors, such as moderately elevated
cholesterol levels, who may be at greater than apparent risk for a
cardiovascular event," explains James H. Stein, MD, Associate
Professor, University of Wisconsin Medical School. Dr. Stein is the
Director of the University of Wisconsin Atherosclerosis Imaging
Research Program and principal investigator of the study.
"Although IMT is recognized as a valuable adjunct in
cardiovascular risk stratification, it primarily has been used as a
research tool," Dr. Stein stated. "With the advent of high-resolution,
hand-carried ultrasound systems and software algorithms, it is more
practical to incorporate this tool into clinical practice. Through
this trial, we hope to determine if health care professionals can
accurately perform this exam in the office setting and thereby detect
cardiovascular disease before it causes a heart attack or stroke."
Until recently, measuring cholesterol or C-Reactive Protein (CRP),
an indicator of blood vessel inflammation, have been among the few
options in evaluating the risk of cardiovascular disease. However,
clinical studies suggest that IMT may be more predictive and specific
to cardiovascular risk than either CRP or traditional lipid profile
alone, making IMT an important tool for identifying patients at
increased risk for cardiovascular disease.
Called "OPACA" for Office Practice Assessment of Carotid
Atherosclerosis using Handheld Ultrasound Study, investigators plan to
enroll 525 patients at medical centers located in Philadelphia;
Minneapolis; New York City; Chicago; Boise, Idaho; and Rochester,
Minnesota. Data collection and analysis is expected to be completed by
June of 2006. The study will use SonoSite's MicroMaxx(TM) system with
embedded SonoCalc(TM) software, a hand-carried ultrasound system
weighing just under eight pounds, and a L38 linear array transducer.
The noninvasive ultrasound examination can be completed in
approximately 15 minutes and does not expose a patient to ionizing
radiation.
"Moving IMT out of the research lab and into the physician's
office is part of our long-term vision for incorporating ultrasound
into the physical examination," said Kevin M. Goodwin, SonoSite
President and CEO. "We are pleased to join with Dr. Stein and the
other study investigators in their efforts to find practical and
cost-effective methods for preventing and lowering the risk of heart
disease."
Introduced a year ago at the 2004 AHA Scientific Sessions,
SonoSite's patented SonoCalc(TM) IMT automated edge detection
technology provides physicians with the ability to analyze the IMT of
a patient's carotid artery. IMT has been used as an indicator of
efficacy in the development of several statin and antihypertensive
drugs and is widely recognized as a surrogate marker for identifying
and evaluating the vascular disease and its progression, both
indicators of heart disease and stroke.
SonoSite will be offering IMT screenings in Booth 533 during the
AHA Scientific Sessions from November 13-16 being held at the Dallas
Convention Center. For more information on the OPACA trial, contact
Hal Widlansky, Global Director, Cardiovascular at 425-951-1206.
About SonoSite
SonoSite, Inc. (www.sonosite.com) is the innovator and world
leader in hand-carried ultrasound, with an installed base of more than
20,000 systems. Headquartered near Seattle, SonoSite is represented by
eight subsidiaries and a global distribution network in over 75
countries. SonoSite's small, lightweight systems are expanding the use
of ultrasound across the clinical spectrum by cost-effectively
bringing high-performance ultrasound to the point of patient care. The
company employs approximately 470 people worldwide.