FAME Data Demonstrates 30% Reduction in Composite Events When Using Routine
FFR Guidance in Multi-Vessel Disease
WASHINGTON, Oct. 15 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC) today announced the launch of the PrimeWire(TM) Pressure Guidewire, and the s5-FFR Option for its existing installed base of s5 and s5i imaging consoles in the U.S. The PrimeWire is Volcano's newest pressure guidewire, capable of measuring pressure gradients across a lesion to determine the ischemic nature of the stenosis, and can also help determine the extent to which the blockage is flow-limiting. The s5-FFR Option is now available for existing s5 and s5i consoles currently installed throughout the U.S. and Europe to enable these IVUS consoles with FFR (fractional flow reserve) technology. Volcano continues to be the only company offering an imaging console capable of high-frequency rotational IVUS, fast digital IVUS, and FFR.
The one-year follow-up of the FAME study (FFR vs. Angiography for Multivessel Evaluation) was presented yesterday at TCT and confirms the beneficial clinical and economic impact of FFR when used routinely to guide treatments of multi-vessel disease. "The FAME study is among the most important studies in today's DES therapy era. FAME demonstrates that when physicians employ FFR to guide multi-vessel PCI treatment, their patients benefit both clinically and economically. The FFR-guided interventions for multi-vessel disease are also cost effective for hospitals and payers. FAME confirms the benefits of routine FFR for the multi-vessel patient just as the earlier Deferral versus Performance of PTCA in Patients Without Documented ischemia (DEFER) study demonstrated in single-vessel disease, but does so in a larger patient population and in a randomized fashion," commented Morton Kern, MD, professor of medicine and associate chief, Division of Cardiology, University of California, Irvine.
FAME randomized 1005 patients diagnosed with multi-vessel coronary artery disease at 20 European and US centers to either angiography-guided PCI (n=496) or FFR-guided PCI (n=509) all using current DES regimens. FAME's objective was to compare angiographic guidance to FFR guidance and to determine which coronary lesions required revascularization. FAME demonstrated that FFR- guidance in routine multi-vessel PCI resulted in clinically-superior outcomes and reduced the composite of death, documented myocardial infarction, and repeat revascularization by 30 percent at one year. The study also demonstrated that adhering to an FFR-guided regimen for multi-vessel disease is cost beneficial to the hospital and payers by reducing procedural costs ($5,332 vs. $6,007), lowering average length of hospitalization (3.4 days vs. 3.7 days), and reducing the number of drug eluting-stents necessary per patient (1.9 vs. 2.7). The data also showed that the implementation of FFR did not add time to the multi-vessel PCI procedure.
DEFER is a landmark study demonstrating that patients with intermediate disease not treated with PCI based on FFR guidance achieved long-term outcomes out to five years equivalent to patients who underwent PCI for similar intermediate lesions. DEFER outlines a revascularization strategy for angiographically equivocal stenoses that deploys FFR technology to identify and treat only those lesions producing reversible ischemia. The Journal of the American College of Cardiology has recognized the five-year follow-up results of the DEFER trial as one of the studies with the greatest impact on clinical cardiology in 2007. (JACC Vol. 51, No. 4, 2008 January 29, 2008:490-512)
PrimeWire(TM) and s5-FFR Option
Volcano is pleased to announce the launch of the new PrimeWire Pressure Guidewire, which is compatible with Volcano's s5 family of integrated imaging consoles. Volcano's PrimeWire was showcased yesterday at TCT in two live case demonstrations performed at Columbia Presbyterian Medical Center in New York and at Riverside Medical Center in Columbus, Ohio. "The launch of the PrimeWire underlines Volcano's commitment to this very important Functional Measurement (FM) market and, in light of yesterday's important presentation of the FAME study, we look forward to working with our customers to bring the PrimeWire and our state-of-the-art FFR technology to the benefit of patients," said Scott Huennekens, Volcano's President and Chief Executive Officer.
Volcano's PrimeWire measures intracoronary pressure to derive an FFR index. FFR expresses maximum achievable blood flow in a coronary artery with the presence of an abnormal stenosis as a fraction of maximum blood flow achievable in the absence of a stenosis. FFR is 100% specific in identifying lesions actually restricting blood flow enough to cause ischemia.
Hospitals with Volcano's s5 and s5i imaging consoles in the U.S. and Europe can now acquire the FFR functionality to support the PrimeWire and add this important tool to their existing IVUS system and workflow.
Joe Burnett, Associate Vice President, marketing commented, "Earlier- generation consoles included only one of the three technologies now available on the s5. If a hospital wanted to equip a new lab with all three technologies, they would have to acquire three separate consoles, each with a different measurement modality, training requirements and data storage protocols. The Volcano s5 can now accommodate the three primary intravascular diagnostic tools in regular use by cardiologists today (high frequency rotational IVUS, fast and simple digital IVUS, and pressure-based FFR guidewires) on a single platform, making modern day imaging consoles more flexible than ever before."
About Volcano Corporation
Volcano Corporation (NASDAQ: VOLC) 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(TM) 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) systems and catheters. Currently, more than 3,500 Volcano IVUS and FM systems are installed worldwide, with approximately half of its revenues coming from outside the United States. For more information, visit the company's website at http://www.volcanocorp.com.
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 commercial prospects for, or potential customer use of, the PrimeWire Pressure Guidewire and the s5-FFR Option. Forward-looking statements involve risks and uncertainties and are based on management's current expectations. Actual results could differ materially from these forward-looking statements as a result of certain factors, including the risks and uncertainties related to the development of new products and their commercial acceptance, and other factors discussed in Volcano's filings with the Securities and Exchange Commission, including in its Annual Report on Form 10-K for the year ended December 31, 2007 and in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2008. Undue reliance should not be placed on forward-looking statements, which speak only as of the time they are made. Volcano undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, changed assumptions or otherwise. Actual results or experience could differ materially from the forward-looking statements.
|SOURCE Volcano Corporation|
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