FDA Clears Zargis' Pioneering Medical Device
02 June 2004 - 2:00AM
PR Newswire (US)
FDA Clears Zargis' Pioneering Medical Device First Computer-Aided
Device to Assist in the Detection of Heart Murmurs PRINCETON, N.J.,
June 1 /PRNewswire/ -- Zargis Medical Corp., a majority- owned
subsidiary of Speedus Corp. (NASDAQ:SPDE), announced today it has
received U.S. Food and Drug Administration (FDA) clearance to
market Zargis Acoustic Cardioscan (Cardioscan), the first and only
computer-aided medical device to support physicians in analyzing
heart sounds for the identification of suspected murmurs, a
potential sign of heart disease. "Zargis is the only company that
has been able to achieve this significant milestone, which
demonstrates our outstanding technical expertise and core
competency in this clinically important field," said Zargis
President and Chief Executive Officer, Shahram Hejazi, Ph.D. "We
are extremely pleased by this FDA clearance which helps pave the
way for future Zargis products. It is our hope that Cardioscan, the
first product of its kind, will become the new standard of care,"
said Silvano Dall'Asta, Zargis Director and CFO of Zargis partner,
Siemens Corporate Research, Inc. About Cardioscan Cardioscan is
easy to use, non-invasive, portable, and takes just minutes to
perform. Developed by biomedical scientists from Siemens and Zargis
over the past seven years, Cardioscan acquires, processes and
analyzes heart sounds, then provides easily interpretable graphical
and textual results to physicians. Using Cardioscan to identify
suspected murmurs through the assessment of patients' heart sounds,
physicians will have an added tool available to them in identifying
the presence of murmurs that will assist them in their
determination of whether further testing or specialized attention
from a cardiologist is warranted. In addition, Cardioscan will
provide an electronic and printable record of a patient's heart
sounds, giving the physician a baseline, and an additional means by
which to detect and track changes over time. Dr. Alvin J. Chin, MD,
Professor of Pediatrics, University of Pennsylvania School of
Medicine and Zargis advisor said, "I was most impressed with the
Cardioscan prototype. It is simple, clean, elegant and will be a
valuable decision support tool for most physicians". Cardioscan
will initially be launched to a select group of physicians,
teaching hospitals and other health care professionals. About the
FDA Submission A clinical study utilizing data obtained from
leading national medical centers including Children's Hospital of
Philadelphia, Texas Heart Institute in Houston and St. Francis
Medical Center in Roslyn, N.Y. demonstrated the detection of heart
murmurs by Cardioscan with a sensitivity of 91.8% and a specificity
of 68.0%. A study published by the American Medical Association(1)
reported only 20% correctness among 450 internal medicine and
family practice physician residents in identifying 12 basic heart
sounds and murmurs. Listening to the heart with a stethoscope
remains the most widely used method for the detection of heart
murmurs. Cardioscan also achieved 91% sensitivity and at least 92%
positive predictivity in the identification of S1 and S2, two
dominant heart sounds in each heart beat that are important for the
identification of heart murmurs. S1 is commonly referred to as the
"lub" sound and S2 the "dub" sound. About Heart Murmurs Certain
types of valvular and congenital heart disease are manifested by
heart murmurs and proper interpretation is essential for accurate
diagnosis and disease management. According to published studies,
it is estimated that approximately 30% of the adult population, and
up to 80% of children are affected by heart murmurs. Although only
a small percentage of these murmurs result from heart disease, and
even fewer are life threatening, the American Heart Association
states that valvular heart disease affects more than 20 million
people in the United States, while another 1 million Americans are
living with congenital cardiovascular defects. Moreover, according
to the same report, mortality for diseases of the heart that may be
related to a murmur is in excess of 49,000 per year. "Cardioscan
can be an important tool for aiding in the early identification and
assessment of sounds that could signify heart disease," said Dr.
Hejazi. "This device could provide doctors with a much needed tool
to help them provide better care to their patients while optimizing
the healthcare process." Zargis Growth Opportunities Given the
limitations of the human auditory system, Zargis believes that one
day computer-assisted detection of sounds will be utilized in every
patient encounter where a stethoscope is used. Zargis and its
partners are committed to supporting continued research and
development to commercialize medical products that facilitate the
detection, monitoring and diagnosis of diseases which are
manifested by cardiac and respiratory sounds. Zargis Medical Corp.
was formed in January 2001 when Siemens Corporate Research Inc., a
subsidiary of Siemens AG (NYSE:SI), and Speedus Corp. (NASDAQ:SPDE)
co-invested in Zargis to further develop and commercially market an
advanced acoustic technology for detecting heart murmurs and other
abnormalities. Based in Princeton, New Jersey, Zargis is developing
advanced diagnostic decision support products and services for
primary care physicians, cardiologists and other healthcare
professionals. For additional information about Zargis Medical
Corp., contact Shahram Hejazi, 609.734.6530, , or visit their
website at http://www.zargis.com/. For additional information on
Speedus Corp., contact John Kallassy, 718.567.4358, , or visit
their website at http://www.speedus.com/. For additional
information on Siemens Corporate Research, visit their website at
http://www.scr.siemens.com/. (1) "Study: Most new doctors can't use
stethoscope; Only 20 percent 'hear' common heart problems,"
CNNinteractive, 1997.
http://www.cnn.com/HEALTH/9709/02/nfm.heart.sounds/ Statements
contained herein that are not historical facts, including but not
limited to statements about the Company's product, corporate
identity and focus, may be forward-looking statements that are
subject to a variety of risks and uncertainties. There are a number
of important factors that could cause actual results to differ
materially from those expressed in any forward- looking statements
made by the Company, including, but not limited to, the continuing
development of the Company's sales, marketing and support efforts.
DATASOURCE: Zargis Medical Corp. CONTACT: Shahram Hejazi,
+1-609-734-6530, , for Zargis Medical Corp.; or John Kallassy,
+1-718-567-4358, , for Speedus Corp Web site:
http://www.speedus.com/ http://www.scr.siemens.com/
http://www.zargis.com/
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