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"Angiography alone is not enough and more and more clinical data continue to support that message," said Scott Huennekens, President and CEO of Volcano. "Many physicians attending the TCT believe that minimally invasive, catheter based therapies are the best solution for the vast majority of patients - in terms of reduced morbidity and increased patient comfort, convenience, safety and greater cost effectiveness. Yet, large clinical studies continue to call these catheter-based therapies into question. Our belief at Volcano is that a sole reliance on a less precise imaging tool like the angiogram is what is holding back the interventional field. We need to take advantage of more precise guidance tools such as IVUS and FFR if we expect to continue the progress that interventionalists have made in the past 30 years."
Clinical Trial Results
On Wednesday, September 23, at 12:15 PM the two-year results of the FFR vs. Angiography for Multi-Vessel Evaluation (FAME) study will be announced in the main arena at TCT. The one-year FAME study results, originally presented at TCT 2008 and published in the New England Journal of Medicine, demonstrated that patients with multi-vessel coronary artery disease who were treated with FFR guidance had a significant reduction in major adverse coronary events (MACE) compared to angiographic guidance alone. Not only were these improvements seen clinically, but there was also a reduction in the total procedural cost in the FFR-guided group. At TCT, the 2-year FAME data will be presented to examine the sustained benefits of FFR guidance over a longer period of time, in addition to specific patient demographic subsets. Patient safety, better outcomes and lower costs are central topics in healthcare reform and FFR is an easy-to-use, accessible tool that is available in most hospitals world wide.
Following the FAME announcement, the first follow-up results of the much anticipated PROSPECT trial (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) will be presented on Thursday, September 24 at 12:15 PM in the main arena at TCT. PROSPECT is the first multicenter natural history study using Volcano's grayscale IVUS and proprietary VH IVUS technology, designed to examine which lesions progress rapidly in patients, and which lesions remain stable for years to come. Data has been collected for more than three years on these patients, and the event data will be presented for the very first time at TCT. Detailed results of the study will also be the focus of the first session of Volcano's symposium that evening. Gregg W. Stone, M.D., Principle Investigator of PROSPECT, will discuss how plaque characterization can help predict future coronary events at the symposium.
"Despite years of effort, researchers using the traditional angiogram have had great difficulty predicting which lesions will progress versus which will not," said Joe Burnett, Vice President of Volcano. "PROSPECT is designed to show that not all coronary disease is the same. Some lesions may progress rapidly and lead to events. Others may remain stable for years. In the same way that biopsies are performed to stage different types of cancers, PROSPECT will determine the ability of VH IVUS to help cardiologists risk-stratify various types of atherosclerotic plaques. We hope that the data from PROSPECT will be able to identify which lesions are likely to be aggressive and lead to events, and which lesions are more likely to be stable and left alone. This may be the first step to determining which patients will benefit from early intervention and one day reduce the number of sudden heart attacks."
Breakfast Symposium
Volcano is hosting a breakfast symposium entitled "Right Patient, Right Lesion, Right Way: Healthcare reform demands precise, targeted interventions ... angiography alone is not enough." This session will focus on the importance of using more precise tools to identify which patients and lesions benefit most from stenting, and once identified, using precise imaging tools to ensure these stents are placed optimally. Speakers for this session include Morton Kern, M.D., William French, M.D. and Hoang Thai, M.D. The event will be held in room 123 of the Moscone Center on Wednesday, September 23. Breakfast will be served at 6:30 AM followed by the symposium at 7:00 AM.
Evening Symposium
Volcano will host an evening symposium entitled, "Imaging Matters! Identifying high risk patients and optimizing PCI." The symposium will include late breaking results from PROSPECT, FAME and other clinical studies. The first session of the symposium, entitled, "Can imaging help identify at-risk vulnerable plaques and patients before catastrophe (or those not at risk)," will feature presentations from Patrick W. Serruys, M.D., Gary S. Mintz, M.D., Gregg W. Stone, M.D. and Alexandra Lansky, M.D. The second session, entitled, "Ischemia, FFR and Optimal Revascularization," will include presentations by Gregg W. Stone, M.D., Bernard de Bruyne, M.D., PhD, Bill Fearon, M.D. and Mort Kern, M.D. The event will be held at the Hilton San Francisco in the Imperial Room on Thursday, September 24. A reception will be held from 7:00 PM - 8:00 PM, followed by the symposium from 8:00 PM - 10:00 PM.
"Interventional cardiology has continuously improved outcomes for the past 30 years," continued Burnett. "However there are still a significant number of events that take place in patients that have been treated in the cath lab, and many more victims of sudden heart attacks that don't make it to the cath lab at all. In both cases, the causes often remain unclear and unexplained by angiography. Volcano is committed to providing therapy guidance tools designed to augment angiography and provide physicians with the tools they need to continue advancing the specialty forward."
Live Case Demonstrations and Hands-On Demonstrations
During the week of TCT, Volcano will collaborate with physicians globally to provide a full schedule of live demonstration cases with Volcano's innovative intravascular imaging and intracoronary physiology products. These products are readily available to the interventional community as Volcano has more than 4,400 systems installed worldwide. Volcano will also host education, training and live demonstrations of the company's newest intravascular imaging and intracoronary physiology products at the Volcano booth #411.
About Volcano Corporation
Volcano Corporation (Nasdaq: VOLC | Quote | Chart | News | PowerRating) offers a broad suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart disease and guide optimal therapies. The company's intravascular ultrasound (IVUS) product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab. Volcano IVUS offers unique features, including both single-use phased array and rotational IVUS imaging catheters, and advanced functionality options, such as VH((R)) IVUS tissue characterization and ChromaFlo((R)). Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires and is developing a line of ultra-high resolution Optical Coherence Tomography (OCT) and Forward-Looking IVUS systems and catheters. Currently, more than 4,400 Volcano IVUS and FM systems are installed worldwide, and more than half of Volcano's revenues are derived from outside the United States. Through its wholly-owned subsidiary, Axsun Technologies, Volcano also develops and manufactures optical monitors, lasers and optical engines used in telecommunications, spectroscopy and other industrial applications. These products are sold to a variety of customers, including Nokia Siemens, Ericsson, Alcatel-Lucent and HuaWei Technologies. For more information, visit the company's website at http://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 regarding Volcano's business that are not historical facts may be considered "forward-looking statements," including statements regarding the expected benefits and market adoption of the company's technology, the impact of clinical and other technical data, including with respect to the studies described above. 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 the results predicted are detailed in the company's annual report on Form 10-K, quarterly reports on Form 10-Q and other filings made with the Securities and Exchange Commission. 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
http://www.volcanocorp.com
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