SAN DIEGO, Calif., May 21, 2012 /PRNewswire/ -- Volcano
Corporation (NASDAQ: VOLC), a worldwide leader in precision guided
therapy tools, today provided an overview of data from multiple
ground-breaking clinical trials presented last week at the EuroPCR
conference, a key international cardiology meeting held in
Paris, France.
"We provide tools that allow physicians to guide procedures
based on functional data, in contrast to imprecise tools such as
angiogram which provide images that are not always definitive,"
said Joe Burnett, Executive Vice
President and General Manager of Volcano's Functional Measurement
business unit. "Physiology, and particularly Fractional Flow
Reserve (FFR), has been proven to improve outcomes in powerful,
well-validated clinical trials like DEFER, FAME and now FAME II,
which was presented this week at EuroPCR. As a pioneer in the
field, we feel very strongly that there is tremendous potential for
worldwide adoption of functional assessment across many clinical
indications and FFR can be made faster, simpler and more cost
effective – driving more personalized care and ultimately, better
outcomes for patients."
Volcano's Proprietary Instant Wave-Free Ratio™ (iFR®)
Functionality: An Emerging Tool
Three datasets were presented for the first time at EuroPCR
that expand the clinical data supporting Volcano's proprietary
Instant Wave-Free Ratio™ Functionality (iFR® Functionality).
The goal of iFR® Functionality is to provide a functional,
lesion-specific assessment in seconds, without injecting a
vasodilator drug to induce stress on the heart. The iFR®
Functionality and algorithm are being developed in a collaboration
between Volcano and researchers at the Imperial College London.
Volcano iFR® Functionality is under development and not approved
for sale in any markets.
"Today's technology enables us to explore coronary pressure and
flow waveforms in a way that furthers our basic understanding of
how coronary artery disease works – including the relationship of
the coronary blockage itself with the surrounding myocardium," said
Justin Davies, MD, PhD, Imperial
College London. "Although the vast majority of iFR® Functionality
and FFR cases 'agree', it is fascinating to look at the few cases
where there is disagreement and to explore the physiology behind
these cases."
Presented by Dr. Davies, the ADenosine Vasodilator Independent
Stenosis Evaluation (ADVISE) Registry compared Volcano's
proprietary iFR® Functionality with Fractional Flow Reserve (FFR)
technologies, the gold standard test for evaluating lesion
severity. Data from an all-comer registry of 339 lesions confirmed
that Volcano's proprietary iFR® Functionality demonstrated an
excellent correlation with FFR.
The ADVISE Registry enrolled 339 lesions across four sites in
the United Kingdom and
Spain, with a real-world clinical
distribution of lesion severity. When compared to the intrinsic
variability of FFR for the same lesion distribution, iFR®
Functionality showed 94% relative diagnostic accuracy versus FFR
(81% concordance observed in the distribution as a fraction of the
85% expected concordance for this clinical distribution). Of the
cases showing discordance between iFR® Functionality and FFR, 41%
lay within 0.01 of the FFR cut-off point (0.80), and 81% were
within the FFR grey zone of 0.75-0.80.
The ADVISE Hyperemic Stenosis Resistance (HSR) Study assessed 51
lesions, calculating Volcano iFR® Functionality, FFR, and a third
independent metric of lesion severity, HSR. iFR® Functionality
showed the same diagnostic accuracy versus HSR (92%) as FFR versus
HSR (92%). iFR® Functionality showed an Area Under the Curve (AUC)
of 0.93 versus HSR, which had no statistical difference from the
AUC of FFR versus HSR of 0.96 (p=0.48). The study also showed that
in the 4 of 51 lesions (8%) that disagreed between Volcano iFR®
Functionality and FFR, there was equal agreement with HSR. The data
confirms that Volcano iFR® has comparable accuracy as FFR when both
are compared to an independently validated metric of lesion
severity (HSR).
An independently-conducted study presented by Dr. Jin Joo Park of Seoul National University Hospital enrolled 243
consecutive patients across 3 trial sites in Korea. Baseline
pressure tracings (from which Volcano iFR® Functionality values
could be derived off-line), along with FFR values using both
intravenous and intracoronary adenosine, were obtained. The
baseline pressure tracings were sent to a Volcano iFR®
Functionality core lab at Imperial College London in blinded
fashion, meaning that the core lab operators were completely
blinded to the corresponding FFR values. Of 238 lesions meeting
pre-specified inclusion/exclusion criteria, the Area Under the
Curve was 0.89 with diagnostic accuracy of 81%. On adjustment for
the intrinsic variability of FFR for this distribution, relative
diagnostic accuracy was 94%. This data demonstrates for the first
time an excellent correlation of Volcano iFR® Functionality and FFR
in a completely blinded analysis.
"Volcano iFR® Functionality has created an unprecedented
interest among interventional cardiologists," commented Javier
Escaned, MD, PhD from Hospital Clinico San Carlos in Madrid, Spain. "Since the online publication
of the ADVISE study last December, over 800 patients have been
analyzed to compare Volcano iFR® Functionality and FFR, and a very
vivid debate on iFR® Functionality has taken place in scientific
journals and international meetings. The European and South Korean
registries presented in Paris,
based on data analyzed with the ADVISE algorithms, reported a high
diagnostic accuracy of Volcano iFR® Functionality in identifying
FFR significant stenoses. This supports the concept that a robust
analysis of data is crucial to calculate iFR® Functionality, and
probably explains why the VERIFY registry, that uses a different
analysis algorithm and was first presented at the ACC Congress last
March, failed in reproducing ADVISE results."
"While we are extremely pleased with the performance to date,
Volcano is committed to further clinical and mechanistic studies of
iFR® Functionality, across multiple patient populations," added
Neil Hattangadi, MD, Vice President
and Business Unit Leader for Intravascular Therapies at Volcano.
"We will launch global trials and perform analysis by a blinded,
independent, iFR® Functionality core lab to ensure this metric
continues to be rigorously validated."
New Developments in FFR
Additionally, results from the FAME II (Fractional Flow
Reserve-Guided Percutaneous Coronary Intervention Plus Optimal
Medical Treatment vs. Optimal Medical Treatment Alone in Patients
with Stable Coronary Artery Disease) study demonstrated clearly
that patients with significant lesions identified via FFR did
significantly better when stented compared with those treated with
optimal medical therapy alone. This study was halted early by the
independent Data and Safety Monitoring Board (DSMB) because the
non-stenting (medically-treated) arm had significantly more urgent
revascularizations than the FFR-guided stenting group. Data
presented at EuroPCR 2012 showed an 11.2 times greater risk of
urgent revascularization in the non-stenting group compared to the
group that used FFR-Guided 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. Its 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 procedures described above, further development and
expansion, regulatory approval, 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 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, growth strategies, timing
and achievement of product development milestones, outcome of
ongoing litigation, the impact of market development,
decisions by regulatory bodies, 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.
SOURCE Volcano Corporation