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Volcano Announces Preliminary Results from the ADVISE II Study and Inclusion in the SYNTAX2 Trial During Hot Line Late Breaking



 Volcano Announces Preliminary Results from the ADVISE II Study and Inclusion
in the SYNTAX2 Trial During Hot Line Late Breaking Clinical Trial Sessions at
                                 EuroPCR 2013

  PR Newswire

  SAN DIEGO and PARIS, May 23, 2013

-- Prospective, Multi-Center, Double-Blinded Study Confirms Prior Results in
evaluating Volcano's iFR® (Instant Wave-Free Ratio™) Software Modality in a
Large, Real-World Population

SAN DIEGO and PARIS, May 23, 2013 /PRNewswire/ -- Volcano Corporation (NASDAQ:
VOLC), a leading developer and manufacturer of precision guided therapy tools
designed to enhance the diagnosis and treatment of coronary and peripheral
vascular disease, today announced preliminary results from the ADVISE ( Ad
enosine V asodilator I ndependent S tenosis E valuation) II trial during the
hot line late breaking clinical trial session at EuroPCR 2013. These
prospective results confirm prior retrospective publications, and demonstrate
the clinical usefulness of an iFR®/Fractional Flow Reserve (FFR) Hybrid
approach to simplify lesion assessment and to save the use of hyperemic drugs
in a significant number of patients. It was also announced that this Hybrid
iFR®/FFR strategy, along with intravascular ultrasound (IVUS) guidance, will
be used in the multi-center SYNTAX2 trial in Europe starting later this year.

"An important step in the validation of any new technology is to identify a
hypothesis based on observations, and to then prospectively test the
hypothesis in a large number of centers to see if the observations translate
to real-world practice," commented Javier Escaned, MD, PhD, Interventional
Cardiologist at Hospital Clínico San Carlos, Madrid, Spain. "The ADVISE II
study is the first prospective test of the true iFR algorithm that is analyzed
through an independent physiology core lab (Cardialysis, Rotterdam,
Netherlands).  These preliminary results show that the prior observations can
be replicated prospectively, and that a Hybrid iFR/FFR approach can provide a
greater than 90% agreement with FFR while saving the use of hyperemic agent in
more than half of patients."

The ADVISE II findings replicated prior iFR® retrospective publications which
demonstrated  that use of a Hybrid iFR®/FFR workflow delivered an overall
classification agreement with an FFR in more than 90% of patients
participating in the trial, while saving more than 50% of such patients from
hyperemic drug administration. In fact, the preliminary analysis showed 91.5%
agreement with FFR and 71.5% hyperemic drug savings on a per lesion basis.
Patients in ADVISE II were recruited from more than 40 centers in the United
States and Europe, and all analysis was performed with operators blinded from
the iFR® values which were calculated offline at an independent core lab in
Rotterdam, Netherlands.

Also presented this week were results from the first 392 real-time cases
performed live in the cath lab from more than 20 centers in Europe, Japan and
South Africa that are now equipped with the iFR® software. These results
confirmed the prior results and those of the preliminary ADVISE II findings
being presented at EuroPCR.

"After using iFR in real world clinical practice, its simplicity is clearly
its strength. In a busy cath lab, saving time is important and the results in
my early experience have been consistent and clinically useful," commented
Andrew Sharp, MD, Interventional Cardiologist at Royal Devon & Exeter
Hospital, Exeter, United Kingdom. "Once real-world operators have the
opportunity to use both of these complementary technologies, I think they will
be impressed."

Also announced at EuroPCR 2013 was the investigator-led SYNTAX2 study, which
will be co-sponsored by Volcano and Boston Scientific Corporation. SYNTAX2 is
designed to test precision guided percutaneous coronary intervention (PCI),
using a clinical SYNTAX score as derived at Cardialysis in Rotterdam along
with live iFR®/FFR Hybrid measurements of the vessel to determine which
patients and lesions are treated. Boston Scientific SYNERGY™ drug-eluting
stents will then be placed with IVUS guidance, using both Volcano and Boston
Scientific IVUS devices, to provide more accurate stent placement than has
been demonstrated with angiography alone.  

"Modern-day stent design and techniques have improved dramatically since the
very first SYNTAX study was enrolled more than five years ago," commented
Professor Patrick Serruys, Rotterdam, Netherlands. "It is widely believed in
the community that PCI is an excellent alternative to coronary bypass surgery
in the right patients. The SYNTAX2 study will use a new 'clinical SYNTAX
score' to first identify prospective patients we believe will benefit from a
less-invasive PCI procedure, and then use physiology and IVUS guidance along
with the modern-day drug-eluting stent technology. The goal is to show that
delivering the most precise and modern-day PCI possible will allow more
patients to be treated with this excellent alternative to bypass surgery." 

"The fact that iFR has now been validated in more than 3,000 patients as part
of these studies makes us comfortable in our understanding of the performance
of the tool," commented Michel Lussier, President of Scientific and Clinical
Affairs at Volcano. "iFR is not a replacement for FFR given the wealth of
outcome data generated over the years in DEFER, FAME and FAME II. Future
studies like SYNTAX2 that include iFR will now focus on clinical, economic and
quality of life outcomes rather than comparisons to FFR now that those
questions have been answered. This is an exciting time and we look forward to
offering this tool to clinicians and interested researchers around the world
to further the evidence that physiology can provide that next leap in
improving PCI."

About Volcano Corporation

Volcano Corporation is revolutionizing the medical device industry with a
broad suite of technologies that make imaging and therapy simpler, more
informative and less invasive.   Our products empower physicians around the
world with a new generation of analytical tools that deliver more meaningful
information - using sound and light as the guiding elements.  Founded in
cardiovascular care and expanding into other specialties, Volcano is changing
the assumption about what is possible in improving patient outcomes by
combining imaging and therapy together.

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 that are not historical facts may be considered "forward-looking
statements." including statements regarding the potential benefits of the
products and technologies described above, further development and expansion,
anticipated clinical trials and the impact of clinical and other technical
data. Forward-looking statements are based on management's current
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 include the pace and extent of market adoption
of the company's products and technologies; unexpected clinical trial results,
including unexpected new clinical data and unexpected additional analysis of
existing clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; competition in general;
government, industry and general public pricing pressures; unexpected
manufacturing issues; growth strategies; timing and achievement of product
development milestones; outcome of ongoing litigation; the impact and benefits
of market development; product introductions; unexpected new data, safety and
technical issues; market conditions; and other risks inherent to medical
device development and commercialization. These and additional risks and
uncertainties are more fully described in Volcano's filings made with the
Securities and Exchange Commission, including our  recent quarterly report on
Form 10-Q. 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.

Website: http://www.volcanocorp.com
Contact: Edrienne Brandon, Volcano Corporation, +1-858-720-4136,
ebrandon@volcanocorp.com, or Neal Rosen, +1-650-458-3014,
nrosen@volcanocorp.com
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