Volcano Announces Positive Clinical Experience With Its Second Generation OCT Catheter, Prepares for U.S. Regulatory Study
SAN DIEGO, May 20 /PRNewswire-FirstCall/ -- 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® 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 5,200 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/.
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