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PROSPECT Study Published in The New England Journal of Medicine Demonstrates That Volcano's IVUS and VH® IVUS Technologies Can Assess Risk of a Future Clinical Event Better Than Using Angiography Alone
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VH® IVUS
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January 19, 2011 -- San
Diego -- Volcano Corporation (Nasdaq: VOLC) today announced the publication
of results from the PROSPECT (Providing Regional Observations
to Study Predictors of Events in the Coronary Tree) study in
The New England Journal of Medicine showing that grayscale intravascular
ultrasound (IVUS) and Volcano's proprietary VH® IVUS tissue characterization
software enable physicians to more accurately assess the risk
of individual blockages than the use of the current standard-of-care--
angiographic imaging-- alone. |
Dr. Gregg W. Stone, Principal Investigator of
the PROSPECT study and Professor of Medicine at Columbia University
College of Physicians and Surgeons, Director of Cardiovascular Research
and Education at the Center for Interventional Vascular Therapy at
New York-Presbyterian Hospital/Columbia University Medical Center,
said, "The landmark PROSPECT study has confirmed two key principles
that will be relevant as we continue to innovate and improve our treatment
of cardiovascular disease. First, angiographic guidance alone is not
a good predictor of future events; grayscale intravascular ultrasound
is much better than angiography at determining the severity of plaque,
and which blockages are most likely to cause future events. Second,
all coronary artery disease is not the same, and differences in underlying
tissue type can in fact change the risk profile of a lesion. Some blockages
are more active and can quickly progress to a clinical event. Other
blockages are more stable, and when combined with proper medical therapy,
have an extremely low risk of causing a future event. For the first
time, we have been able to prospectively identify these lesions both
by size and by tissue type using VH IVUS."
The PROSPECT study, which was funded by Abbott
Corporation and Volcano Corporation, is the first and only natural
history study that tracked the clinical outcomes, hospital readmissions,
and subsequent coronary events of patients with acute coronary syndrome
(ACS). The study followed 700 U.S. and European patients with ACS over
three years. The investigators assessed these patients' coronary arteries
by taking very detailed measurements and interior images of all three
arteries. The PROSPECT study showed that of the 55 imaging parameters
measured, grayscale IVUS and VH® IVUS identified the only individual parameters that could statistically predict lesion risk for future clinical events. When combined together, grayscale IVUS and VH® IVUS
uncovered lesion characteristics that PROSPECT showed predict the highest
lesion risk for future clinical events.
Scott Huennekens, President and CEO commented, "The
need to improve patient care and reduce cost has led to more personalized
medicine. For personalized medicine to work, we must rely on better
diagnostic tools to determine which patients will or will not benefit
from therapy. PROSPECT shows us that we can go beyond the limitations
of a two-dimensional x-ray and better separate these blockages into
higher risk and lower risk."
The investigators found that certain high-risk
lesions, including those with a relatively small lumen area and a large
amount of plaque, and a significant amount of dead tissue or necrosis
near the lumen as identified by VH® IVUS, had an almost 20% risk of
a cardiac event within three years. These lesions were classified as
'predictive' by the investigators. Conversely, certain low-risk lesions
where that same necrotic tissue was not present in the study had a
significantly lower event rate of only 0.6% out to three years. These
lesions were termed 'protective' by the investigators.
"Heart disease is the number one killer in the world," said Pauliina Margolis, MD, PhD, and Chief Medical Officer at Volcano. "The more we can understand about the disease we are treating, the further we can advance as a cardiology community. VH® IVUS
tissue characterization has been studied in more than 10,000 patients
globally. PROSPECT has provided an important step forward by showing
that we can see a difference in lesions, supported by clinical evidence."
About Coronary Artery Disease (CAD)
Coronary artery disease (CAD) affects tens of millions of Americas each year and is the leading cause of death in the United States and globally. CAD occurs when the coronary arteries (the blood vessels that nourish the heart with oxygen, blood and nutrients) become blocked or narrowed due to plaque build-up, thereby restricting adequate blood flow to the heart. As this disease worsens overtime, CAD can go virtually unnoticed until signs of chest pain (angina), shortness of breath, heart palpitations, or other symptoms manifest. In severe cases, CAD can cause a heart attack (myocardial infarction) or sudden coronary death.
About Volcano Corporation
Volcano Corporation (NASDAQ: VOLC) is revolutionizing the medical device industry with a broad suite of technologies that make imaging and therapy simpler, more informative and less invasive. Our products empower physicians around the world with a new generation of analytical tools that deliver more meaningful information, using sound and light as the guiding elements. Founded in cardiovascular care and expanding into other specialties, Volcano is changing the assumption about what is possible in improving patient outcomes by combining imaging and therapy together. For more information, visit the company's website at www.volcanocorp.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning
of the U.S. Private Securities Litigation Reform Act of 1995. Any statements
in this release that are not historical facts may be considered "forward-looking statements," including statements regarding the potential benefits of the products and procedures described above, the pace and extent of market adoption of the company's technologies, implications of the data from the PROSPECT clinical study, and the impact of clinical and other technical data. Forward-looking statements are based on management's current preliminary expectations and are subject to risks and uncertainties which may cause Volcano's results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include competition, unexpected new data, safety and technical issues, the clinical study results mentioned in this press release not being predictive of real world results, and market conditions. The market potential for IVUS and Volcano's proprietary VH® IVUS
may also be affected by government and commercial reimbursement and
pricing decisions; the pace and extent of market adoption and acceptance;
scientific, engineering, regulatory and other issues; or other risks
inherent in the development and commercialization of medical devices.
These and additional risks and uncertainties are more fully described
in Volcano's filings made with the Securities and Exchange Commission,
including the current report on Form 8-K filed September 13, 2010.
Undue reliance should not be placed on forward-looking statements which
speak only as of the date they are made. Volcano undertakes no obligation
to update any forward-looking statements to reflect new information,
events or circumstances after the date they are made, or to reflect
the occurrence of unanticipated events.
Source: Volcano
Corporation
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