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Volcano Corporation Announces Launch of PrimeWire™ Pressure Guidewire and s5-FFR Option for Existing Fleet of s5 IVUS Consoles
FAME Data Demonstrates 30% Reduction in Composite Events When Using Routine FFR Guidance in Multi-Vessel Disease
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October 15, 2008 / Washngton DC --
Volcano Corporation (Nasdaq: VOLC) today announced the launch of
the PrimeWire™ 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. FAME
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
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™
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™ tissue characterization and ChromaFlo®. 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.
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 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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