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Product Launches
Volcano is pleased to announce the launch of the new PrimeWire PressureGuidewire, which is compatible with Volcano's s5 family of integrated imagingconsoles. "The launch of the PrimeWire underlines Volcano's commitment tothis very important Functional Measurement (FM) market. Groundbreaking datapresented over the past year, including the DEFER study five year follow-upand the FAME study which will be presented at this year's TCT, highlight theimportance of only treating truly ischemic lesions, a characteristic that canoften be missed with angiography alone. These powerful data, combined withthe launches of our new PrimeWire and s5 console with IVUS and FFR, will onlyfuel FFR education and usage, and Volcano will continue to make strides towardmarket leadership," Scott Huennekens, president and CEO of Volcano.
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Hospitals with Volcano's s5 and s5i imaging consoles in the U.S. andEurope can now acquire the FFR functionality to support the PrimeWire and addthis important tool to their existing IVUS system and workflow.
Volcano also offers two different IVUS platforms that are compatible withour newest integrated IVUS consoles. Revolution is Volcano's first high-frequency coronary imaging catheter and operates at a 45 MHz frequency,providing increased resolution and clarity in the near-field. The Revolutioncan accommodate a 15 cm pullback inside of a stationary, protective sheath,and also includes a reinforced proximal shaft, robust locking mechanism, andRFID catheter-to-console communication that are designed for consistent,reliable image quality.
Joe Burnett, associate vice president, marketing commented, "Earlier-generation consoles included only one of the three technologies now availableon the s5. If a hospital wanted to equip a new lab with all threetechnologies, they would have to acquire three separate consoles, each with adifferent measurement modality, training requirements and data storageprotocols. The Volcano s5 can now accommodate the three primary intravasculardiagnostic tools in regular use by cardiologists today (high frequencyrotational IVUS, fast and simple digital IVUS, and pressure-based FFRguidewires) on a single platform, making modern day imaging consoles moreflexible than ever before."
Evening Symposium
Volcano's first-ever TCT evening symposium will focus on "The future ofintravascular imaging: How IVUS, FFR, VH IVUS, CTO Imaging and OCT can improvepatient outcomes." Speakers for this symposium include Alex Abizaid, M.D.,Augusto Pichard, M.D., Matthew Price, M.D. Mort Kern, M.D., David Williams,M.D., Guilio Guagliumi M.D., Gary Mintz, M.D. and Steven Marso, M.D. Theevent will be held in the Renaissance ballroom at the Marriott RenaissanceHotel near the Convention Center on Tuesday, October 14. A reception willstart at 7:00 PM, and the symposium begins at 8:00 PM.
Live Case Transmissions
During the week of TCT, Volcano will collaborate with physicians globallyto provide a full schedule of live case demonstrations of Volcano's innovativeintravascular imaging and intracoronary physiology products. This willinclude transmissions featuring Volcano's fast and easy-to-use s5 family ofIVUS consoles, including Volcano's s5i customized integrated cath lab formatand GE Healthcare's unique-in-the-industry Innova IVUS system.
Clinical Trial Updates
On Monday, October 13, a session chaired by Valentin Fuster and AttilioMaseri will focus on Vulnerable Plaque Trials and Therapies: Focusing aSubspecialty, Part I: Natural History and Medical Therapy in Room 152A. Theprogram includes presentations on the PROSPECT (Providing RegionalObservations to Study Predictors of Events in the Coronary Tree) and IBIS II(Integrated Biomarker and Imaging Study) trials.
Gregg W. Stone, M.D., Principle Investigator of PROSPECT will presentbaseline demographic and imaging data from the complete set of almost700 patients. "As the first prospective natural history study examiningwhether novel blood and imaging tests are able to identify patients at riskfor future death and heart attack, PROSPECT promises to provide groundbreakingdata critical to understanding the progression of coronary artery disease, andrepresents the first step toward identifying patients at high risk who maybenefit from preventative therapies," said Dr. Stone. PROSPECT is a globalstudy with over 40 centers participating worldwide, aimed at determining thelikelihood of specific plaque types to cause heart attacks.
Following the PROSPECT presentation, Patrick Serruys, M.D., Ph.D. will bepresenting results from GlaxoSmithKline's IBIS-2 trial. In the study,Volcano's VH(R) IVUS technology demonstrated and quantified compositionalchanges in atherosclerotic plaque that occurred over time. VH(R) IVUS alsoshowed compositional changes in the placebo group that suggest continuedprogression of necrotic core despite standard of care medical therapy. Use ofthe novel Lp-PLA2 inhibitor, darapladib, plus standard of care therapyappeared to prevent this progression.
The Volcano VH Registry, aimed at correlating plaque characteristics withpatient demographics, clinical presentation, and cardiac risk factors, has nowcompleted enrollment of over 3,000 patients worldwide. Seven separateabstracts pooled from the VH Registry data will be presented throughout theweek of TCT highlighting correlations in diverse patient subsets.
Expanded Booth Presence to Demonstrate New Products
Volcano will feature an expanded product expo area in the commercialexhibit spaces at TCT. Please visit us in booth #1006 at TCT for a completetour of Volcano's newest intravascular imaging and intracoronary physiologyproducts.
About Volcano Corporation
Volcano Corporation (VOLC), which completed its IPO in June 2006, offers abroad suite of devices that facilitate endovascular procedures. Volcano'sproducts enhance the diagnosis of vascular and structural heart diseases andguide optimal therapies. The company's IVUS (intravascular ultrasound)product line includes ultrasound consoles that can be integrated directly intovirtually any modern cath lab and single-use phased array and rotational IVUSimaging catheters. Volcano also has unique advanced functionality optionslike VH tissue characterization and IVUS and angiography co-registration.Volcano also provides functional measurement (FM) consoles and single-usepressure and flow guide wires. Currently, more than 2,000 Volcano IVUS and FMsystems are installed worldwide, with nearly half of its revenues coming fromoutside the United States. For more information, visit the company's websiteat http://www.volcanocorp.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaningof the U.S. Private Securities Litigation Reform Act of 1995. Any statementsin this release regarding Volcano's business that are not historical facts maybe considered forward-looking statements, including statements regarding theability of VH(R) IVUS to measure the effects of investigational compounds, theability to identify and characterize composition and to define patientstrategy to improve patient outcomes. Forward-looking statements involve risksand uncertainties and are based on management's current expectations. Actualresults could differ materially from these forward-looking statements as aresult of certain factors, including the risks and uncertainties related tothe results of clinical studies and other factors discussed in Volcano'sfilings with the Securities and Exchange Commission. Undue reliance should notbe placed on forward-looking statements, which speak only as of the time theyare made. Volcano undertakes no obligation to update any forward-lookingstatements to reflect new information, events or circumstances, changedassumptions or otherwise. Actual results or experience could differ materiallyfrom the forward-looking statements.
SOURCE Volcano Corporation
