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Volcano Announces FDA 510(k) Clearance of Revolution Rotational Catheter and FFR for the s5i Integrated IVUS Console
First ever imaging system that incorporates phased Array IVUS, Rotational IVUS and integrated FFR all onto a single platform, providing Physicians and Administrators Choice
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February 7, 2008 -- San Diego --
Volcano Corporation (Nasdaq: VOLC), a leading manufacturer of intravascular
ultrasound
(IVUS) and functional measurement (FM) technology, announced today
FDA 510(k) clearance of the s5-Revo and s5-FFR (fractional flow reserve)
options. These two new product offerings now enable rotational IVUS
and FFR to operate on the same integrated Volcano s5 Imaging System
as Volcano's previous line of phased array IVUS catheters and functionality.
For the first time, physicians can choose among three powerful diagnostic
tools -- all on the same integrated IVUS platform.
Scott Huennekens, president and chief executive
officer of Volcano, commented, "Volcano welcomes the addition of
these two important technologies to the s5 family of consoles.
By adding high resolution rotational IVUS and pressure-based FFR
to our already highly successful phased array s5 imaging platform,
we will be providing a level of technology, clinical utility and
convenience that is un-matched in the intravascular imaging field.
Physicians, nurses and administrators can now have fast, easy access
to state-of-the-art therapy guiding technologies like IVUS and
FFR. No other company currently provides a system that integrates
this level of functionality and convenience in a single platform.
Our message now is simple; Volcano offers all three technologies
on one system, you the physician can now choose which technology
is best for you, best for your staff, and best for your patient." 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. Joe
Burnett, associate vice president of marketing for Volcano,
said, "The past three years of engineering work have culminated
in the launch of this product, and underline the concept of
choice in the cardiac cath lab. The new s5 integrated product
will appeal and offer choice to two distinct customer groups;
First, for cath lab administrators who are trying to accommodate
different physician preferences and practice patterns the Volcano
s5 platform now offers all three primary technologies on one
platform. As a result, cath lab managers can ensure their individual
physician preferences are met with one system. Second, the
Volcano system will appeal to physicians themselves, as they
will now have three powerful diagnostic tools on one platform,
all at-the-ready for their patients. If a physician wants a
high resolution IVUS image to measure plaque burden, they can
select a Revolution(TM) IVUS catheter. If they want a fast,
simple IVUS image to assess stent placement, they can quickly
plug in an Eagle Eye(R) Gold IVUS catheter. If they want to
objectively measure lesion severity prior to committing to
a therapeutic strategy, they can use a Volcano FFR guidewire.
The ability to choose any or all of these technologies, and
quickly implement them should the need arise, is a powerful
message that has resonated well with our customers." Training
and Education
In preparation for the s5-Revo and s5-FFR launch,
Volcano has increased its training offering to incorporate
more robust site education on all three of these primary
technologies. Housing three diverse diagnostic tools on the
same console not only increases access to the technology
but streamlines and simplifies staff training, as all three
tools are run through the same, consistent user interface. Craig
A. Thompson, MD, MMSc and the Director of the Cardiovascular
Catheterization Laboratory at the Dartmouth-Hitchcock Medical
Center commented, "As a major teaching institution for
Interventional Cardiologists, it is our responsibility
to ensure every trainee is versed in the full line of diagnostic
modalities available to improve patient care. The Volcano
system will allow us to improve exposure to various IVUS
and FFR applications through a common interface, which
will enrich our training programs and the acumen of our
fellows moving forward."
Availability
The first installations of the Volcano s5-Revo and s5-FFR Options
under a limited market release strategy will commence shortly with a full market
release expected in the first half of 2008. The Volcano s5-Revo and s5-FFR
options complement the existing s5 functionality, including ChromaFlo(R) for
stent apposition assessment, and VH(TM) IVUS plaque composition analysis. The
Volcano s5 Imaging System has been tested in cooperation with GE, Philips,
Siemens and Toshiba for safety and compatibility when used with their current
lines of x-ray systems and equipment. The Volcano s5 has also been tested
for compatibility with eleven different DICOM providers, and for Worklist
compatibility with image storage in the same patient "jacket" as the angiogram. 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 diseases 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. Currently, more than 2,900 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 press release regarding Volcano's business that are not historical
facts may be considered "forward-looking statements," including statements
regarding the company's success and timing of product development and
new product introductions, including the installations of the Volcano
s5-Revo and s5-FFR Options, the expected performance enhancements of
its products, the integration of our products into new or existing cath
labs, and market penetration, conditions and expectations. 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 were made, or to reflect the occurrence
of unanticipated events. Source: Volcano Corporation
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