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Volcano Corporation Announces Upcoming Presentation of Late-Breaking Clinical Trial Results and FFR Product Launch at TCT 2011
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November 4, 2011 -- San Diego -- Volcano Corporation (NASDAQ: VOLC), a leading developer and manufacturer of precision guidance therapy tools designed to enhance the treatment of coronary and peripheral vascular disease, today announced that results from the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) clinical trial, sponsored by Volcano, will be presented in a Late-Breaking Session at Transcatheter Cardiovascular Therapeutics (TCT 2011), which is taking place from November 7-11 in San Francisco .
Volcano also announced it is launching a new fractional flow reserve (FFR) pressure wire, the PrimeWire PRESTIGE™ PLUS, Volcano's newest FFR wire and the third pressure guidewire it has introduced in the last three years. It represents Volcano's latest advancement in its goal of delivering the precision of FFR guidance with the utility of a frontline guidewire.
Volcano will highlight its broad portfolio of Precision Guided Therapy products in clinical, educational and technology showcases throughout TCT 2011, including:
- Tuesday, November 8: 7:00 am - 8:00 am
Breakfast Symposium - Treating the Complex Lesion: Techniques and Technology for Left Mains and Bifurcations
Moscone Convention Center, Room 114
Chair: David Rizik, MD; Faculty: John Hodgson, MD, Bon-Kwon Koo, MD
- Wednesday, November 9: 10:00 am
Edited Taped Case Presentation: Development and Application of instant wave-Free Ratio (iFR): A New Pressure-Derived Adenosine-Free Measure of Fractional Flow Reserve: A First-in-Man Showcase
Presentation Theater North (Napa Valley), Moscone Center
Operator: Justin Davies, MD, PhD
- Thursday, November 10: 7:00 am - 8:00 am
Breakfast Symposium - Breaking Down Barriers to FFR
Adoption: Introducing iFR, a Vasodilator Independent Measure of Fractional Flow Reserve
Moscone Convention Center, Room 123
Chair: Morton J. Kern, MD; Faculty: Justin Davies, MD, PhD, Javier Escaned, MD, PhD
- Friday, November 11: 12:15 pm
Late-Breaking Results from the ADVISE Clinical Trial: Validation of a Vasodilator Independent Measure of Coronary Fractional Flow Reserve
Main Arena III: Esplanade Ballroom
Presenter: Justin Davies, MD, PhD
Precision Guided Therapy Leadership
FFR has become the gold standard for objective, lesion specific measurement of ischemia in the catheterization laboratory. FFR and IVUS are supported by ACC/AHA/ESC and SCAI guidelines, reimbursed under current CPT codes and are a reported metric in national registry quality reports for top hospitals across the country. FFR and IVUS-guided PCI continue to gain acceptance over angiography alone, yet they are used in less than 20 percent of procedures in the U.S.
Consistent with its cadence of innovation, Volcano is expanding its Functional Management offerings to include an investigational product called instant™ wave-Free Ratio or iFR™. In collaboration with physicians at Imperial College and Hospital Clinico San Carlos, Volcano is developing a technology with the objective of achieving FFR-like measurements without the use of Adenosine, a vasodilator injected to achieve maximum coronary flow, which can increase time, cost and complexity of the procedure, and cause patient discomfort. iFR is designed to provide a pharmaceutical-free means of assessing the functional performance of a discrete lesion as a measure of FFR.
In an effort to make the benefits of FFR accessible to more clinicians and patients, Volcano is working with suppliers of hemodynamic monitoring systems to provide FFR on their systems. Volcano's Smart Map Pressure Instrument is now compatible with the FFR module of the Philips Xper Flex Cardio Physiomonitoring System. This complements Volcano's current compatibility with GE Healthcare's Mac-Lab® XT and XTi hemodynamic recording systems version 6.8.1, Siemens' AXIOM Sensis XP VC11, McKesson's Horizon Cardiology™ Hemo version 12.1, and Mennen's Horizon XVu Hemodynamic Monitoring System.
"The healthcare environment is demanding more from physicians and hospitals to ensure that PCI therapy is performed only when appropriate, and only in patients for whom the benefit is proven," stated Scott Huennekens, President and CEO of Volcano Corporation. "Our FFR and IVUS technologies will help physicians, hospitals and payers quantify and document ischemia and disease severity in just minutes. Our goal is to make precision-guided PCI the new standard of care in an environment that demands both quality and cost efficiency."
Volcano will also highlight its currently available products and offering hands-on training sessions, including an FFR simulator in Booth #1317.
About Volcano Corporation
Volcano Corporation 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 light and sound 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." Forward-looking statements are based on management's current 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 include the pace and extent of market adoption of the company's products and technologies, growth strategies, timing and achievement of product development milestones, the impact and benefits of market development, product introductions, unexpected new data, safety and technical issues, market conditions, dependence on third parties, and other risks inherent to medical device development and commercialization. These and additional risks and uncertainties are more fully described in Volcano's filings made with the Securities and Exchange Commission, including our recent quarterly report on Form 10-Q. 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
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