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Volcano Announces 510(k) Clearance, CE Mark Approval, and First Clinical Use for the PrimeWire PRESTIGE™ Pressure Guide Wire
Next generation Fractional Flow Reserve Guide Wire provides even greater opportunities for physicians to save costs and improve patient outcomes
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Volcano's
PRESTIGE
Pressure Guide Wire |
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May 19, 2010 -- San Diego --
Volcano Corporation (Nasdaq: VOLC) announced today it received
both 510(k) clearance and CE Mark approval for its PrimeWire
PRESTIGE™ Pressure Guide Wire for use with patients who have
both single-vessel and multi-vessel disease. This next generation
pressure wire is compatible with Volcano's full suite of integrated
multi-modality consoles and stand-alone physiology systems as
well as various hemodynamic monitoring systems. The first clinical
cases with the device have taken place at various U.S. and European
sites. Commercial launch of the PrimeWire PRESTIGE™ is expected
in June 2010. |
"The first PrimeWire PRESTIGE™ Pressure Guide Wire cases underline our commitment to delivering innovation and choice to our customers and patients," said Scott Huennekens, President and CEO of Volcano Corporation. "Our
goal is to provide simple, easy-to-use products that address the
complex challenges, like multi-vessel disease, that clinicians
encounter each day. Multiple blockages usually have more tortuous
tissue to navigate through, take longer to address, and may require
more devices passing over-the-wire to deliver treatment. The PrimeWire
PRESTIGE™ is an advanced wire designed to help guide multi-vessel
disease decision-making." "The clinical data from the FAME study supporting the use of FFR to guide stent placement in multi-vessel disease patients is very strong, and has led to the upgrade of ACC/AHA/SCAI guidelines to level of evidence A," commented Dr. Mort Kern, Chief of Cardiology for the VA Long Beach Health System and Associate Chief of Cardiology at UC-Irvine Medical Center. "One
key hurdle that physicians continuously battle with is the accurate
and efficient diagnosis of lesion significance at the time of the
procedure. Any improvement to the performance of today's FFR wires
that make assessment of multi-vessel disease lesions easier and
faster is a welcome change to physicians."
The PrimeWire PRESTIGE™ Pressure Guide Wire has a redesigned core intended to improve mechanical performance, such as torque transmission, vessel navigation, and support. A recent internal study confirmed that PRESTIGE™ substantially outperformed the previous generation PrimeWire® with respect to torque transmission. The redesigned tip also improves tactile feel and tip shape memory. PrimeWire PRESTIGE™ will launch simultaneously with the new upgraded v3.2 Software for the Volcano s5i, which provides an optimized FFR workflow for ease of use.
CE Mark approval allows Volcano to market PrimeWire PRESTIGE™ in certain international markets, primarily in Europe. Volcano also has 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market PrimeWire PRESTIGE™ in the U.S.
"The PrimeWire PRESTIGE™ represents a significant improvement in performance to the previous generation FFR wire," commented Dr. Hoang Thai, Director, Cardiac Catheterization Laboratory and Interventional Cardiology, Southern Arizona Veterans' Affairs Health Care System Medical Center and Associate Director, Interventional Cardiology Fellowship Program Sarver Heart Center, University of Arizona. "I
have been committed to using FFR in these complex patients for
some time, and it is great to see a product evolving along with
my practice to make my decision-making in the cath lab easier and
more predictable."
About Volcano's Physiology Products
Volcano offers the broadest physiology product portfolio available today, which includes pressure and Doppler flow wires designed to deliver FFR, Coronary Flow Reserve (CFR) or both measurements simultaneously on the same wire. Volcano's s5i system, the only multi-modality system on the market, offers clinicians a choice of five modalities for assessment of lesion morphology and severity on a single platform: digital IVUS for fast plug and play imaging, high-frequency rotational IVUS for higher resolution, VH® IVUS for plaque characterization, ChromaFlo® for imaging blood flow, and FFR for physiological lesion assessment.
About Compatibility with Hemodynamic Monitoring Systems
Volcano's
Smart Map® Pressure Instrument, PrimeWire® Pressure
Guide Wire and PrimeWire PRESTIGE™ Pressure Guide Wire are now compatible with
the majority of hemodynamic monitoring systems, making the benefits of FFR
accessible to more clinicians and patients. Volcano's SmartMap® will provide
a pressure reading to GE Healthcare's Mac-Lab® XT and XTi hemodynamic recording
systems version 6.8.1, Siemens' AXIOM Sensis XP VC11, McKesson's Horizon Cardiology™
Hemo version 12.1, and Mennen's Horizon XVu Hemodynamic Monitoring System.
With the pressure measurement derived from Volcano's family of PrimeWire®
products, hemodynamic monitoring systems have the ability to calculate the
FFR gradient and display the FFR measurement on the hemodynamic screen in the
cath lab. About Volcano Corporation
Volcano Corporation offers a broad suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart disease 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 digital and rotational IVUS imaging catheters, and advanced functionality options, such as VH® IVUS tissue characterization and ChromaFlo®. Volcano also provides Physiology consoles and single-use pressure and flow guide wires and is developing a line of ultra-high resolution Optical Coherence Tomography (OCT) systems and catheters. Currently, more than 5,000 Volcano IVUS and Physiology systems are installed worldwide, with approximately half of Volcano's revenues coming
from outside the United States. Volcano's wholly-owned subsidiary, Axsun Technologies, develops and manufactures optical monitors, lasers and optical engines used in telecommunications, medical imaging, spectroscopy and other industrial applications. For more information, visit the company's website at http://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 regarding Volcano's business that
are not historical facts may be considered "forward-looking statements," including
statements regarding the potential benefits of the products and procedures
described above, results and implications of the data from the FAME trial,
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 preliminary 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 from the results
predicted are detailed in the company's annual report on Form 10-K, quarterly
report on Form 10-Q and other filings made with the Securities and Exchange
Commission. 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
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