Healthcare Industry News:  Volcano 

Devices Interventional Cardiology Regulatory

 News Release - August 2, 2007

Volcano Corporation Announces Japan Approval of the Revolution(R) 45 MHz High-Frequency Rotational IVUS Imaging Catheter and System

Volcano's 45 MHz Revolution(R) rotational IVUS imaging catheter to be highest frequency IVUS catheter available in key Japanese market

RANCHO CORDOVA, Calif. and TOKYO, Aug. 2 (HSMN NewsFeed) -- Volcano Corporation today announced approval of the Revolution® 45 MHz rotational IVUS imaging catheter and related accessories by necessary regulatory authorities in Japan, granting entry into the Japanese market. This approval covers use of the Revolution® Catheter when used on Volcano's IVG IVUS system. Volcano expects to launch the Revolution catheter into Japan, which represents the largest intravascular ultrasound (IVUS) market worldwide, during the fourth quarter of this year. Volcano has already commenced shipments of the Revolution® catheter into the U.S. and Europe.

Antonio Colombo, MD, Director of the Cardiac Catheterization Laboratory at Columbus Hospital and Chief of Invasive Cardiology at San Raffaele Hospital, both in Milan, Italy commented, "I believe that IVUS guidance improves patient outcomes when used as part of routine stenting technique and I now try to use IVUS on all patients receiving stents. Many of my colleagues in Japan have reached the same conclusions, with more than 60% of stenting procedures in Japan now utilizing IVUS imaging. I have now used Volcano's Revolution catheter in a number of patients, including live case presentations at TCT and the JIM meeting in Italy with excellent results. Images are very easy to interpret, and provide excellent measurements of the coronary vasculature, helping to verify proper stent expansion and full stent apposition."

"The Revolution® IVUS catheter has high resolution and significantly improved image quality as compared to Volcano's other IVUS catheters -- I have great expectations for Volcano's new IVUS catheter," commented Junko Honye, M.D., Ph.D., Assistant Professor of Medicine, Department of Cardiovascular Medicine, Nihon University School of Medicine in Japan. "At my facility, almost all interventional cases have used IVUS since PCI was introduced. In addition, since the DES late thrombosis concern has arisen, the use of IVUS is now even more important. It is fortunate that Volcano's new catheter has been approved at this time."

Scott Huennekens, Volcano's president & chief executive officer commented, "Approval of the Revolution catheter and SpinVision(TM) pullback system in Japan -- the largest market in the world for IVUS -- is a significant milestone as it enables Volcano to be the only company to offer both simple, easy-to-use phased array IVUS catheters and high frequency, fine resolution sheathed rotational IVUS catheters." Mr. Huennekens continued, "Over the years, many Japanese physicians have developed an affinity for sheathed, rotational IVUS catheters. The approval of the Revolution catheter along with our simple, accurate SpinVision(TM) pull-back system will allow us to compete very effectively for these physicians' business."

"This follows our announcement two weeks ago that we had received regulatory approval for Volcano's s5i integrated IVUS platform in Japan. These two important regulatory milestones provide us solid momentum to support our growth strategies in that important market."

About Volcano Corporation

Volcano Corporation 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) IVUS tissue characterization. Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires. Currently, more than 2,700 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 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 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 launch of s5i in Japan, 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 Corp

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