Healthcare Industry News: Allura
News Release - July 23, 2007
Volcano Corporation Announces Japan Approval of the s5i Integrated IVUS PlatformLaunch of Volcano s5i represents the first integrated IVUS system available in Japanese Market
RANCHO CORDOVA, Calif. and TOKYO, July 23 (HSMN NewsFeed) -- Volcano Corporation (Nasdaq: VOLC ) today announced approval of the s5i Integrated IVUS System by necessary regulatory authorities in Japan, granting entry into the Japanese market. Volcano expects to launch the s5i into Japan, which represents the largest Intravascular Ultrasound (IVUS) market worldwide, during the current quarter. Volcano has already launched the s5i Integrated IVUS system into the U.S. and Europe.
Peter Fitzgerald, MD, PhD, Professor of Medicine and Engineering and Director of the Center for Cardiovascular Technology at Stanford University commented, "I believe that IVUS guidance improves patient outcomes when used as part of routine stenting technique. Japanese physicians seem to agree, as the use of IVUS in PCI has become the standard of care in Japan, with more than 60% of stenting procedures incorporating IVUS imaging. Because IVUS has become an essential part of the Japanese procedural workflow, it makes perfect sense to integrate the IVUS system so that it becomes part of the lab as well."
Scott Huennekens, Volcano's President & CEO commented, "Approval of the s5i system in Japan is a significant milestone as it makes Volcano the only company to offer an integrated IVUS console to the largest worldwide IVUS market. With a continued investment in clinical research and development, we hope to solidify IVUS as the standard of care in Japan, and believe that the lessons learned through IVUS by Japanese physicians will help increase the use of IVUS in the U.S. and Europe as well."
Ron Waxman, MD at the Washington Hospital Center added, "We recently performed an analysis of 7,000 patients at our center and concluded that the incorporation of IVUS guidance into everyday PCI procedures can reduce the patient risk of stent thrombosis by a statistically significant margin. We have always been IVUS advocates, but these new findings have driven IVUS use at the Hospital Center to its highest level ever. I recently presented this data in Japan where it was well received as Interventional Cardiologists in Japan have a high usage of IVUS and low rates of stent thrombosis."
The s5i is Volcano's first IVUS system that can be integrated into new or existing cath labs. Through a series of customizable components, Volcano can now tailor an integrated IVUS solution to the unique user and workflow needs for virtually any vendor's cath lab type or configuration. This can include multiple controllers and monitors, as well as flexibility in the physical location of the console. The s5i also incorporates Volcano's proprietary real time VH(TM) IVUS tissue characterization functionality that enhances the interpretation of IVUS images, and ChromaFloŽ Stent Apposition analysis which helps physicians confirm proper stent expansion and placement.
Since any integrated IVUS solution interacts at some level with the x-ray imaging system, it's critical that the IVUS system has established compatibility with x-ray system vendors. Volcano's s5i IVUS is the only IVUS system to have undergone extensive safety and compatibility testing with GE (Innova series), Siemens (Axiom Artis FD series), Philips (Allura series), and Toshiba (Inifinix-I series).
Volcano thoroughly tested for electromagnetic interference, degradation of video signal, IT and DICOM compatibility, sufficient grounding of all components, and other governances of the Medical Device Directive and sound engineering practices. Volcano believes that completing these important performance and safety tests is essential to providing hospitals with peace of mind that their equipment investment, and, most importantly, the patients' safety is protected.
The Volcano s5i incorporates Volcano's unique new Bedside Touchpad Controller, which provides the physician and staff ready access to the s5i controls from the convenience of the sterile field. The Volcano Bedside Touchpad Controller is designed to operate beneath a sterile drape, allowing the physician to record IVUS runs, toggle between the different VH(TM) IVUS or ChromaFloŽ functionality, confirm vessel and lumen borders and make detailed manual measurements without having to leave the sterile field.
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.
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 Corporation
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