Physicians Cite Positive
First Clinical Experience with Volcano's Eagle Eye® Platinum
Digital IVUS Catheter
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Eagle Eye® Platinum
digital IVUS catheter |
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May 20, 2010 -- San
Diego -- Volcano
Corporation (Nasdaq: VOLC) announced today the completion of
the first clinical cases using the new Eagle Eye® Platinum digital
IVUS catheter. The procedures were performed in seven centers
within the United States. Commercial launch of Eagle Eye® Platinum
in the U.S. is expected in June 2010.
"Our customer research of
the most important IVUS catheter features found that both improved
deliverability and the ability to easily estimate lesion length
were vital," commented David Sheehan, President of Volcano's IVUS
and Physiology Business Units. |
"We designed the Eagle Eye® Platinum to directly meet those needs. Deliverability was addressed with a more tapered tip, smoother design, and proprietary new GlyDx™ hydrophilic
coating. The overwhelming response in clinical use thus far is
that there is a remarkable difference physicians can feel,
even through stents and challenging lesions. Plus, the three new
radiopaque markers provide instant information, facilitating a more
precise lesion length estimate, right on the angiogram." After
conducting one of the first clinical cases with Eagle Eye® Platinum,
Dr. Craig Thompson, Associate
Professor of Internal Medicine/Cardiology at Yale-New Haven Hospital,
stated, "Physicians need devices that quickly get to where they
are needed without requiring excess manipulation or extra dilations.
In my experience, the Eagle Eye® Platinum catheter clearly represents
a dramatic generational improvement in terms of deliverability
and trackability in complex vascular anatomy. Ultimately, the enhancements
of this catheter could increase usage of IVUS among physicians,
allowing for more precision in the treatment of cardiovascular
disease."
"There are two trends in interventional cardiology for which the Eagle Eye® Platinum is especially well-suited," said Joe Burnett, Executive Vice President of Marketing at Volcano. "First,
more and more procedures are performed using the radial approach,
where physicians access the vasculature through the smaller arteries
in the arm versus the larger femoral artery in the leg. In these
cases, smaller guide catheters are commonly used and there is often
less room near the arm for an external pullback device. The Eagle
Eye® Platinum is the only FDA cleared IVUS catheter that is compatible
with smaller five French (5F) guides. Plus, the new radiopaque
markers for length estimation decrease the reliance on pullback
devices, making this catheter better suited for the radial technique."
"The second trend is a focus on using less contrast and delivering less radiation to patients and staff during PCI procedures," added Burnett. "Again,
these convenient radiopaque markers can assist physicians in lesion
and stent length estimation by reducing the limitations of two-dimensional
angiography, which could lead to the use of less contrast and fewer
x-ray pictures from multiple angles."
"The last couple of years have been challenging for medical device makers to invest and deliver new, innovative products to the cardiac cath lab," continued Sheehan. "We
are thrilled to bring such a significant improvement in catheter
performance to our full line of imaging catheters, and to give
clinicians yet another precision-guidance PCI tool from which to
choose."
Volcano received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Eagle Eye® Platinum digital IVUS catheter in the United States.
About Volcano's Digital IVUS Catheters
The Eagle Eye® Platinum is the third generation of catheters in the Eagle Eye® product line. To date, Eagle Eye® catheters have been used in over 500,000 procedures worldwide. Like Eagle Eye® Gold, the Eagle Eye® Platinum catheter offers fast, plug-and-play functionality as well as grayscale IVUS, VH® IVUS for plaque characterization, and ChromaFlo® for imaging blood flow. About
Volcano Corporation
Volcano Corporation 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 digital and rotational IVUS imaging catheters, and advanced functionality options, such as VH® IVUS tissue characterization and ChromaFlo®. Volcano also provides Physiology 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 5,000 Volcano IVUS and Physiology systems are installed worldwide, with approximately half of Volcano's revenues coming
from outside the United States. Volcano's wholly-owned subsidiary, Axsun Technologies, develops and manufactures optical monitors, lasers and optical engines used in telecommunications, medical imaging, spectroscopy and other industrial applications. 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 potential benefits of the products and procedures
described above, commercial release and market adoption of the company's technology,
and the impact of clinical and other technical data. 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
report 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
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