Volcano Corporation Announces Receipt of CE Mark for Its OCT Imaging System and Catheter

Jan 05, 2010, 08:30 ET from Volcano Corporation

SAN DIEGO, Jan. 5 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC), a leader in the development, manufacture and sales of products for the diagnosis and treatment of coronary and peripheral artery disease, announced today receipt of CE mark for their OCT (Optical Coherence Tomography) imaging system and catheter. Volcano's OCT product line is expected to complement its existing line of IVUS imaging catheters and pressure guide wires used for coronary imaging and lesion assessment.

"This is an important milestone in our development of OCT and highlights the progress of our OCT program overall," noted Vince Burgess, President of Advanced Imaging Systems at Volcano Corp. "Volcano acquired its initial OCT technology through the acquisition of CardioSpectra, Inc. in December 2007. Since that time, the Volcano OCT system has generated positive results in numerous clinical studies in Europe and South America. Building upon the CE mark and pending IDE approval, Volcano plans to use this system in the US and South America as part of a US regulatory trial during 2010. We currently expect commercial release of our first OCT system in Europe in early 2011."

Scott Huennekens, President and Chief Executive Officer of Volcano, commented, "Volcano is committed to expanding our technology leadership in intravascular imaging, both to complement everyday PCI (percutaneous coronary intervention) technique, and to further the understanding of atherosclerotic disease progression. We are working on products that incorporate OCT functionality into our s5i integrated platform, as well as stand-alone OCT systems. Our emphasis continues to be focused around providing a variety of therapy enabling modalities so that the physician can select which technology is most appropriate for each individual patient."

Marc D. Feldman, M.D., Professor of Medicine and Director of the Cath lab at UTHSC San Antonio, Texas commented, "This is an important milestone in the translation of OCT imaging to everyday patient care. The Volcano OCT system is designed to eventually allow the interrogation of an entire coronary artery without concerns regarding patient safety due to larger volume injections or balloon occlusion. The ability to safely image a coronary artery can be utilized for image guided PCI with fast, easy lumen and stent assessments. OCT can also visualize intraluminal thrombus and dissections, as well as assist in the evaluation of newer generations of drug eluting stents and in the assessment of intimal coverage in previously paced stents. It can also allow physicians to evaluate lesion cap thickness down into the 15 micron range. As cardiologists, we spend billions of dollars every year on coronary stents which have been proven to benefit patients. Technologies like OCT should help us better select the most significant blockages to treat, and help us ensure these stents are placed properly."

"This is another step in what Volcano sees as the evolution of OCT," added Mr. Burgess. "We will continue to make improvements to our OCT products and with the addition of the HDSS (High Definition Swept Source) light source developed by our team at Axsun Technologies (a wholly-owned subsidiary of Volcano Corporation), we expect our next generation system to be able to scan the proximal 2/3 of the coronary artery in as little as one second. For this next generation OCT system, our team is focused on enabling our Low Volume OCT (LVOCT(TM)) imaging system. Developing the LVOCT(TM) imaging system will be the key to allowing interventional cardiologists to acquire OCT images during a routine coronary angiographic injection. This extremely low flush volume is expected to allow for optimal imaging while maximizing patient safety, clinical utility and ease-of-use for the physician and staff."

About Volcano Corporation

Volcano Corporation (Nasdaq: VOLC) 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 phased array and rotational IVUS imaging catheters, and advanced functionality options, such as VH® IVUS tissue characterization and ChromaFlo®. Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires, and is developing a line of ultra-high resolution Optical Coherence Tomography (OCT) and Forward Looking IVUS systems and catheters. Currently, more than 4,700 Volcano IVUS and FM systems are installed worldwide, and more than half of Volcano's revenues are derived from outside the United States. Through its wholly-owned subsidiary, Axsun Technologies, Volcano also develops and manufactures optical monitors, lasers and optical engines used in telecommunications, spectroscopy and other industrial applications. These products are sold to a variety of customers, including Nokia, Siemens, Ericsson, Alcatel-Lucent and HuaWei Technologies. 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 systems, products and procedures described above, results and implications of the data from clinical studies, expected regulatory trials and 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 reports 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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