Volcano Corporation (NASDAQ:VOLC) has 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 http://www.volcanocorp.com or call
916/638-8008.
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