SAN DIEGO, May 26 Volcano Corporation (Nasdaq: VOLC) announced today that it has received CE Mark approval for the VIBE(TM) RX Vascular Imaging Balloon Catheter. The company also announced that it has completed its first clinical cases with the VIBE(TM) RX in New Zealand. A single VIBE(TM) RX Catheter can quickly access, prepare, and assess challenging lesions. IVUS guidance provides precise, targeted balloon dilatation with immediate confirmation of interventional results.
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"VIBE(TM) RX represents the first of what we believe will be many Volcano image-guided therapy devices designed to allow physicians to see more detail right at the point of the therapy," commented Scott Huennekens, President and Chief Executive Officer of Volcano. "Although our initial focus is on cardiovascular applications, we believe that this platform can and will be leveraged to many other applications throughout the body. We plan to pursue this broader platform expansion through our internal development and through partnerships with other device manufacturers. Volcano is well-positioned to lead this movement in combining therapy and on-board imaging."
"Volcano has successfully combined two important interventional tools - IVUS and balloon dilatation - into one powerful device," said Dr. John Ormiston, Medical Director at Mercy Angiography in Auckland, New Zealand. "Physicians will have an attractive alternative to using separate IVUS and balloon dilatation catheters in a procedure. The use of imaging for more precise lesion assessment and stent placement has certainly benefited my patients. Integrating imaging directly onto the therapy device removes another barrier to IVUS use. I am pleased to see and be a part of the innovations Volcano is bringing to the cath lab and patients."
"These VIBE(TM) RX product milestones are an important part of our overall s5(TM) and s5i(TM) multi-modality strategy," added Huennekens. "We provide a single system that supports many advanced precision-guided tools. The VIBE(TM) RX is yet another tool that physicians can choose when building their patient or lesion-specific interventional strategy. We welcome this newest addition to our s5(TM) and s5i(TM) multi-modality platforms."
Volcano expects to begin commercial shipments of the VIBE(TM) RX offering in Europe in the third quarter of 2010.
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 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 Image-Guided Therapy products that combine the imaging capability of IVUS with cardiovascular therapeutic devices. Volcano has Physiology consoles and single-use pressure and flow guide wires. 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 is developing a line of ultra-high resolution Optical Coherence Tomography (OCT) systems and catheters, Forward Looking Imaging catheters, and Microcatheters. 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 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, further development and expansion, 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.
Contact: Edrienne Brandon Volcano Corporation 858-720-4136