SAN DIEGO, Jan. 19, 2011 /PRNewswire/ -- 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
