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Volcano Corporation Announces Japan Approval of the s5i Integrated IVUS Platform
Launch
of Volcano s5i represents the first integrated
IVUS system available
in Japanese Market
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July 23, 2007 -- RANCHO CORDOVA, Calif. and TOKYO -- Volcano Corporation (Nasdaq: VOLC) today announced
approval of the s5i Integrated IVUS System by necessary regulatory
authorities in Japan, granting entry into the Japanese market.
Volcano expects to launch the s5i into Japan, which represents
the largest Intravascular Ultrasound (IVUS) market worldwide, during
the current quarter. Volcano has already launched the s5i Integrated
IVUS system into the U.S. and Europe.
Peter Fitzgerald, MD, PhD, Professor of Medicine and Engineering and Director
of the Center for Cardiovascular Technology at Stanford University
commented, "I believe that IVUS guidance improves patient outcomes
when used as part of routine stenting technique. Japanese physicians
seem to agree, as the use of IVUS in PCI has become the standard
of care in Japan, with more than 60% of stenting procedures incorporating
IVUS imaging. Because IVUS has become an essential part of the
Japanese procedural workflow, it makes perfect sense to integrate
the IVUS system so that it becomes part of the lab as well."
Scott Huennekens, Volcano's President & CEO commented, "Approval of the s5i system
in Japan is a significant milestone as it makes Volcano the only company to offer
an integrated IVUS console to the largest worldwide IVUS market. With a continued
investment in clinical research and development, we hope to solidify IVUS as
the standard of care in Japan, and believe that the lessons learned through IVUS
by Japanese physicians will help increase the use of IVUS in the U.S. and Europe
as well."
Ron Waxman, MD at the Washington Hospital Center added, "We recently performed
an analysis of 7,000 patients at our center and concluded that the incorporation
of IVUS guidance into everyday PCI procedures can reduce the patient risk of
stent thrombosis by a statistically significant margin. We have always been IVUS
advocates, but these new findings have driven IVUS use at the Hospital Center
to its highest level ever. I recently presented this data in Japan where it was
well received as Interventional Cardiologists in Japan have a high usage of IVUS
and low rates of stent thrombosis."
The s5i is Volcano's first IVUS system that can be integrated into new or existing
cath labs. Through a series of customizable components, Volcano can now tailor
an integrated IVUS solution to the unique user and workflow needs for virtually
any vendor's cath lab type or configuration. This can include multiple controllers
and monitors, as well as flexibility in the physical location of the console.
The s5i also incorporates Volcano's proprietary real time VH(TM) IVUS tissue
characterization functionality that enhances the interpretation of IVUS images,
and ChromaFlo(R) Stent Apposition analysis which helps physicians confirm proper
stent expansion and placement.
Since any integrated IVUS solution interacts at some level with the x-ray imaging
system, it's critical that the IVUS system has established compatibility with
x-ray system vendors. Volcano's s5i IVUS is the only IVUS system to have undergone
extensive safety and compatibility testing with GE (Innova series), Siemens (Axiom
Artis FD series), Philips (Allura series), and Toshiba (Inifinix-I series).
Volcano thoroughly tested for electromagnetic interference, degradation of video
signal, IT and DICOM compatibility, sufficient grounding of all components, and
other governances of the Medical Device Directive and sound engineering practices.
Volcano believes that completing these important performance and safety tests
is essential to providing hospitals with peace of mind that their equipment investment,
and, most importantly, the patients' safety is protected.
The Volcano s5i incorporates Volcano's unique new Bedside Touchpad Controller,
which provides the physician and staff ready access to the s5i controls from
the convenience of the sterile field. The Volcano Bedside Touchpad Controller
is designed to operate beneath a sterile drape, allowing the physician to record
IVUS runs, toggle between the different VH(TM) IVUS or ChromaFlo(R) functionality,
confirm vessel and lumen borders and make detailed manual measurements without
having to leave the sterile field.
About Volcano Corporation
Volcano Corporation 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) IVUS tissue characterization. Volcano also provides functional
measurement (FM) consoles and single-use pressure and flow guide wires. Currently,
more than 2,700 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 launch of s5i in Japan, 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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