SAN DIEGO, Dec. 15, 2014 /PRNewswire/ -- Volcano Corporation
(NASDAQ: VOLC), a leading company focused on improving patient
and economic outcomes on a global basis by developing and
delivering innovative minimally invasive coronary and peripheral
visualization, physiology diagnostics and therapies, today
announced that more than 1,000 systems have been activated with its
instant wave-Free Ratio™, or iFR® Modality software,
allowing physicians and patients around the globe to benefit from
the simplified workflow, and reduced need for hyperemic agents.
The iFR® Modality is a physiologic measurement
performed using the same pressure wires and equipment utilized in
cardiac catheterization labs for Fractional Flow Reserve (FFR), but
avoids injection of hyperemic agents into the patient that induce
stress to the heart. This allows for a meaningful,
lesion-specific assessment in seconds by amplifying the resting
pressure waveform. The iFR® Modality is used most
efficiently with Volcano's widely adopted Verrata™ Pressure Guide
Wire, which is designed for simple disconnection and reattachment
during a procedure, and facilitates multiple quick measurements
without the need for hyperemic agents.
"We believe that coronary physiology, of any kind, provides
tremendous value to help drive appropriate therapy in patients,"
commented Andrew Tochterman,
Director and Functional Management Segment Leader at Volcano
Corporation. "As a result, technologies like iFR®,
that remove the extra time and cost of hyperemia, have the
potential to increase adoption of coronary physiology and further
optimize patient care. We are extremely pleased with the pace
of adoption of the iFR® Modality and Verrata.
Physicians are quick to comment on the improved workflow, and
potential cost savings associated with the iFR®
Modality. The rate of adoption in the
United States has truly surpassed our expectations,
indicating that tools to improve workflow, and reduce costs are
preferred by clinicians and administrators."
The iFR® Modality and other physiologic guidance
tools including FFR and Coronary Flow Reserve (CFR), are currently
being studied in numerous prospective clinical trials as part of
the DEFINE family of studies. These studies are designed to
explore patient outcomes in a broad array of clinical presentations
in more than 5,000 patients worldwide. The performance of the
iFR® Modality has been tested in approximately 800
patients as part of ADVISE II (Adenosine Vasodilator Independent
Stenosis Evaluation), the first prospective, real world registry
comparing iFR® and FFR. The iFR® Hybrid
Approach Analysis performed in the ADVISE II Study demonstrated a
statistically high correlation (sensitivity 90.7% for FFR less than
or equal to 0.80, specificity 96.2% for FFR greater than 0.80). The
hybrid method would have avoided the need to use a hyperemic agent
in 65.1% of this patient population. Patients in ADVISE II were
recruited from more than 40 centers in the United States and Europe, and all procedures were performed with
operators blinded to the iFR® values which were
calculated offline at an independent core laboratory in
Rotterdam, the
Netherlands.
"We chose to evaluate the hyperemic savings in our own subset of
patients and have been very pleased with iFR®,"
commented Vincent J. Pompili, MD,
FACC, Director, Interventional Cardiovascular Medicine and Cardiac
Catheterization Laboratories at The Ross Heart Hospital at The
Ohio State University Wexner Medical
Center. "In our subset of patients thus far, we've seen more than a
60% reduction in the need for hyperemic agents using the
iFR® Hybrid Approach, which is consistent with the
ADVISE II Study. Our patients appreciate not having to
receive a hyperemic agent but still receive the benefits of
intracoronary physiologic measurements. So far I have been
impressed with the ease of use, and repeatability of the
software."
About Volcano Corporation
Through its multi-modality platform, Volcano Corporation is the
global leader in intravascular imaging for coronary and peripheral
therapeutic devices. The company's broad range of technologies
makes imaging and therapy simpler, more informative and less
invasive and offers physicians and their patients around the world
with industry-leading tools that aid diagnosis and guide and
provide therapy. Founded in cardiovascular care and expanding into
other specialties, Volcano is focused on improving patient and
economic outcomes. For more information, visit the company's
website at 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 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.
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SOURCE Volcano Corporation