SAN DIEGO, March 19, 2014 /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 FDA clearance of its proprietary instant wave-Free
Ratio™ or iFR® Modality.
The iFR® Modality is a physiologic measurement
performed using the same pressure wires and equipment utilized in
cath 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 currently installed on more than
300 systems around the world, primarily in Europe and Japan. FDA Clearance now means that more than
90% of Volcano's worldwide installed base of multi-modality systems
can be upgraded.
"As cardiologists today we are concerned not only with the
wellbeing of our patients, but also about the efficiency with which
we deliver appropriate and individualized care for a very complex
problem," commented Amir Lerman,
M.D., co-principal investigator of ADVISE II and professor of
medicine at the Mayo Clinic in Rochester,
Minn. "Stents have proven beneficial when used selectively in
patients that demonstrate a functional deficiency, and FFR is a
terrific tool to identify the specific lesion causing the problem.
iFR will further increase efficiency by reducing the time, cost and
complexity required to properly identify lesions causing this
functional deficiency, and then confirming the problem is resolved
by the stent."
The iFR® Modality is used most efficiently with
Volcano's recently-introduced Verrata™ Pressure Guide Wire, which
is designed for simple disconnection and reattachment during a
procedure, and facilitates making quick measurements multiple times
during a procedure without injecting hyperemic agents each
time.
"We are extremely excited that both the iFR Modality and Verrata
can now be made available to clinicians here in the United States, as the two tools are
designed to be used together," commented Joe Burnett, Executive Vice President and
General Manager of the FM Business at Volcano. "In Europe, where we
are now seeing how physicians use the two technologies alongside
FFR, the feedback has been very positive. In the past, physicians
would place the wire in the vessel, perform an FFR to 'justify' the
need for intervention, and then return to the angiogram to 'guide'
how many stents should be placed and where. Adding the iFR Modality
and Verrata to the picture, that same physician can now not only
perform FFR to identify the vessel that needs treatment, but also
can switch to iFR to quickly identify which lesion causes the
largest drop in pressure, place a stent, and then re-connect to
confirm that the stent helped reduce the pressure drop. This is a
workflow that would be very uncommon with older wire technology and
the need for multiple drug infusions. This helps to evolve
physiology from a justification tool to a guidance tool."
The performance of the iFR® Modality has been tested
prospectively in approximately 800 patients as part of the ADVISE
II (Adenosine Vasodilator Independent Stenosis
Evaluation) study which was presented as a late breaking clinical
trial at TCT last fall. The iFR Hybrid Approach Analysis performed
on the independently-held ADVISE II dataset was the first
prospective, real world registry comparing iFR and FFR and it
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 lab in Rotterdam, Netherlands.
"As physicians we routinely ask for tools that make these
valuable measurements faster, easier and less expensive to put into
practice," continued Dr. Lerman. "The fewer barriers there are to
use, the more patients that will benefit from guidance tools that
measure live physiology during a procedure. In an environment where
cost, efficiency and personalized medicine workflows are endpoints
of major clinical trials, the hybrid iFR/FFR workflow's 94% match
with FFR and 65% patient reduction in the time and cost of a
hyperemic drug infusion seem to address a couple very significant
barriers and is worth pursuing. If iFR is enough to get non-users
off the fence to embrace physiology, then this can only benefit
patients by moving away from angiography alone."
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 and effectiveness of the products and
technologies described above, further market 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
report on Form 10-K. 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