|
Volcano Announces Positive Clinical Experience With Its Second Generation OCT Catheter, Prepares for U.S. Regulatory Study
|
 |
 |
|
May 20, 2010 -- San Diego --
Volcano Corporation (Nasdaq: VOLC) announced today the successful
completion of Optical Coherence Tomography (OCT) cases with Volcano's
second generation OCT catheter and system.
Pending IDE approval,
Volcano plans to use this OCT system in the US and South America
as part of VOILA, a U.S. regulatory trial during 2010. Commercial
release of Volcano's OCT system is expected in Europe in early
2011 and in the U.S. in mid-2011. |
"St. Jude Medical's acquisition of LightLab confirms the validity and potential utility of this leading edge technology," said Scott Huennekens, President and Chief Executive Officer of Volcano. "We
are planning a best-in-class OCT solution. We currently have CE
Mark in Europe on our first generation platform, and we are targeting
a release of our second generation platform in Europe early next
year. We anticipate that this system will incorporate a smaller
catheter, shorter prep time, faster pullback speed, and a longer
imaging segment than the current device." "Based on landmark clinical trials including FAME and PROSPECT, more and more physicians have recognized the limitations of angiography alone, and are looking for additional tools to enhance their PCI strategy and result," stated Michel Lussier, Group President for Advanced Imaging Systems, Scientific Affairs, and Volcano Europe, Africa, and the Middle East (EAME). "OCT
is one of these new tools, like FFR and IVUS, that can help answer
many of the questions left unclear by a two-dimensional x-ray image."
"OCT provides ultra-high resolution images of the vessel lumen and structural detail not seen before by other imaging modalities," continued Lussier. "With
OCT, physicians will be able to visualize structures in the lumen
and the adjacent vessel wall down to a resolution of approximately
15 microns. We believe the high resolution images that OCT provides
along with the wider field of view, image depth, and plaque characterization
that IVUS delivers will complement each other as physicians focus
on lesion assessment and therapy guidance."
"After achieving CE Mark approval and completing successful clinical trials in multiple countries, we are excited to build on our success and add OCT to Volcano's integrated multi-modality platform," added Lussier. "We
believe that there is no single tool that will be best for every
physician, every patient, or even every lesion. We currently provide
five interventional tools and plan to double the number of modalities
on our system in the coming years."
Dr. Alex Abizaid from the Dante
Pazzanese Cardiology Institute in Sao Paulo, Brazil, said, "The
Volcano OCT system provides fantastic images and is easy to use.
With these OCT images, I can assess thrombus, lesion cap thickness,
tissue growth on previously deployed stents and stent apposition
at the time of implant. This is another great tool in addition
to IVUS and FFR to help me augment angiography."
Volcano's integrated OCT platform will be built around the High-Definition Swept Source (HDSS), a non-laser light source from Axsun Technologies, a wholly-owned Volcano subsidiary. The HDSS has been tested at breakthrough speeds which will translate into ultra-fast imaging and significantly faster pullbacks for the physician.
"We expect to be able to scan the lesion or stent length in as little as one second - literally in a single beat of the heart," concluded Lussier. "This
should allow an OCT scan to be performed during routine angiographic
flush procedures without repeated flushing steps or special protocols."
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(R) IVUS tissue characterization and ChromaFlo(R). 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 5,200 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 and PROSPECT trials, 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
|
