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Volcano Announces FDA 510(k) Clearance of Revolution Rotational Catheter and FFR for the s5i Integrated IVUS Console

First ever imaging system that incorporates phased Array IVUS, Rotational IVUS and integrated FFR all onto a single platform, providing Physicians

and Administrators Choice

SAN DIEGO, Feb. 7 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC), a leading manufacturer of intravascular ultrasound (IVUS) and functional measurement (FM) technology, announced today FDA 510(k) clearance of the s5-Revo and s5-FFR (fractional flow reserve) options. These two new product offerings now enable rotational IVUS and FFR to operate on the same integrated Volcano s5 Imaging System as Volcano's previous line of phased array IVUS catheters and functionality. For the first time, physicians can choose among three powerful diagnostic tools -- all on the same integrated IVUS platform.

Scott Huennekens, president and chief executive officer of Volcano, commented, "Volcano welcomes the addition of these two important technologies to the s5 family of consoles. By adding high resolution rotational IVUS and pressure-based FFR to our already highly successful phased array s5 imaging platform, we will be providing a level of technology, clinical utility and convenience that is un-matched in the intravascular imaging field. Physicians, nurses and administrators can now have fast, easy access to state-of-the-art therapy guiding technologies like IVUS and FFR. No other company currently provides a system that integrates this level of functionality and convenience in a single platform. Our message now is simple; Volcano offers all three technologies on one system, you the physician can now choose which technology is best for you, best for your staff, and best for your patient."

Earlier generation consoles included only one of the three technologies now available on the s5. If a hospital wanted to equip a new lab with all three technologies, they would have to acquire three separate consoles, each with a different measurement modality, training requirements and data storage protocols. The Volcano s5 can now accommodate the three primary intravascular diagnostic tools in regular use by cardiologists today (high frequency rotational IVUS, fast and simple digital IVUS, and pressure-based FFR guidewires) on a single platform, making modern day imaging consoles more flexible than ever before.

Joe Burnett, associate vice president of marketing for Volcano, said, "The past three years of engineering work have culminated in the launch of this product, and underline the concept of choice in the cardiac cath lab. The new s5 integrated product will appeal and offer choice to two distinct customer groups; First, for cath lab administrators who are trying to accommodate different physician preferences and practice patterns the Volcano s5 platform now offers all three primary technologies on one platform. As a result, cath lab managers can ensure their individual physician preferences are met with one system. Second, the Volcano system will appeal to physicians themselves, as they will now have three powerful diagnostic tools on one platform, all at-the-ready for their patients. If a physician wants a high resolution IVUS image to measure plaque burden, they can select a Revolution(TM) IVUS catheter. If they want a fast, simple IVUS image to assess stent placement, they can quickly plug in an Eagle Eye(R) Gold IVUS catheter. If they want to objectively measure lesion severity prior to committing to a therapeutic strategy, they can use a Volcano FFR guidewire. The ability to choose any or all of these technologies, and quickly implement them should the need arise, is a powerful message that has resonated well with our customers."

Training and Education

In preparation for the s5-Revo and s5-FFR launch, Volcano has increased its training offering to incorporate more robust site education on all three of these primary technologies. Housing three diverse diagnostic tools on the same console not only increases access to the technology but streamlines and simplifies staff training, as all three tools are run through the same, consistent user interface.

Craig A. Thompson, MD, MMSc and the Director of the Cardiovascular Catheterization Laboratory at the Dartmouth-Hitchcock Medical Center commented, "As a major teaching institution for Interventional Cardiologists, it is our responsibility to ensure every trainee is versed in the full line of diagnostic modalities available to improve patient care. The Volcano system will allow us to improve exposure to various IVUS and FFR applications through a common interface, which will enrich our training programs and the acumen of our fellows moving forward."


The first installations of the Volcano s5-Revo and s5-FFR Options under a limited market release strategy will commence shortly with a full market release expected in the first half of 2008. The Volcano s5-Revo and s5-FFR options complement the existing s5 functionality, including ChromaFlo(R) for stent apposition assessment, and VH(TM) IVUS plaque composition analysis.

The Volcano s5 Imaging System has been tested in cooperation with GE, Philips, Siemens and Toshiba for safety and compatibility when used with their current lines of x-ray systems and equipment. The Volcano s5 has also been tested for compatibility with eleven different DICOM providers, and for Worklist compatibility with image storage in the same patient "jacket" as the angiogram.

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 diseases 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(TM) tissue characterization and ChromaFlo(R). Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires. Currently, more than 2,900 Volcano IVUS and FM systems are installed worldwide, with approximately half of its revenues coming from outside the United States. For more information, visit the company's website at

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 press release regarding Volcano's business that are not historical facts may be considered "forward-looking statements," including statements regarding the company's success and timing of product development and new product introductions, including the installations of the Volcano s5-Revo and s5-FFR Options, the expected performance enhancements of its products, the integration of our products into new or existing cath labs, and market penetration, conditions and expectations. 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 were made, or to reflect the occurrence of unanticipated events.

SOURCE Volcano Corporation
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