Healthcare Industry News: stent thrombosis
News Release - March 28, 2008
Volcano Announces U.S. and European Launch of Rotational IVUS and Integrated FFRVolcano s5i platform offers multiple diagnostic modalities on a single system and user interface, providing choice for the first time to physicians and administrators
SAN DIEGO, March 28 (HSMN NewsFeed) -- Volcano Corporation (Nasdaq: VOLC ), a leading manufacturer and developer of intravascular ultrasound (IVUS), functional measurement (FM) and Optical Coherence Tomography (OCT) products designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, announced today the U.S. and European launch of the s5-Revo and s5-FFR (fractional flow reserve) options for the s5i integrated Imaging platform. These two new product options now enable rotational IVUS and FFR to operate on the same integrated Volcano s5i Integrated 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, "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. No other company provides a system that integrates this level of functionality and convenience in a single platform. Our message now is simple: Volcano offers physicians all three technologies on one system -- you can choose which technology is best for your patient and clinical team."
Earlier generation consoles included only one of the three technologies now available on the s5i. 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 s5i can now accommodate the three primary intravascular diagnostic tools in regular use by cardiologists today (high frequency rotational IVUS, fast and simple phased array 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, "We believe that IVUS is one of the fastest growing market segments in interventional cardiology today. Our internal market model suggests that worldwide IVUS revenue grew approximately 15% in 2007. More and more physicians are augmenting their daily interpretation of angiography with this more exacting, precise technology. IVUS and FFR can provide objective measurements of lesion severity and stent expansion, thus removing some of the inherent guess work surrounding 2D x-ray images. We believe that having these modalities available on a single integrated system can only further adoption of these important therapy guidance tools."
Training and Education
As part of the s5-Revo and s5-FFR market introduction, Volcano is also launching Volcano TLC, a comprehensive on-site education program available to current and future Volcano customers, targeted to increase IVUS and FFR awareness and build staff proficiency with these new integrated systems. Volcano TLC (Training and Learning Clinics) offers a combination of keynote speaker presentations, physician proctorships, hands-on system training, guided proficiency tools and workflow troubleshooting, all designed to leverage modern-day IVUS and FFR technology, and to allow physicians to acquire these precise diagnostic measurements in less time than ever before.
To kick-off the Volcano TLC program, John McB. Hodgson, M.D., FSCAI will begin an 18 city speaking tour in the US and Canada. Dr. Hodgson will deliver a 90-minute presentation and case review highlighting the essential role of IVUS and FFR in determining lesion severity and guiding proper stent placement and expansion entitled "IVUS and FFR: More Important than Ever. A Guide to Optimal PCI on the Eve of Second Generation DES".
Dr. Hodgson commented, "IVUS and FFR play an invaluable role in modern-day PCI. As practitioners, we are routinely misled by using angiography alone to assess lesion severity and confirm proper stent placement. Although IVUS and FFR have long been available to augment angiography, legacy systems were cumbersome, and access to these systems was too limited to drive broader acceptance."
Dr. Hodgson continued, "The combination of more complex target lesions, concerns about late stent thrombosis, the launch of new faster, integrated IVUS and FFR technologies, and the growing awareness that angiography does not tell the whole story, has driven IVUS use dramatically higher in recent years. It is no wonder that the use of IVUS has increased so rapidly."
The Volcano TLC speaker program with Dr. John Hodgson will visit the following cities over the next three months; New York City, Framingham, Buckhead, Miami, Baltimore, Nashville, Pittsburgh, Cleveland, Rosemont, Milwaukee, Houston, Dallas, Seattle, Las Vegas, San Francisco, Fresno, Montreal and Toronto. For specific dates, times and locations, please refer to the Volcano website at http://www.volcanocorp.com.
Volcano will highlight the new s5i integrated systems at the American College of Cardiology ACC Symposium in Chicago, March 29th to April 2nd. Volcano will have these new systems on display at Booth number #18093 for live demonstrations, as well as transmitting cases from ACC live broadcast sites. The Volcano s5-Revo and s5-FFR options complement the existing s5 functionality, including ChromaFloŽ for stent apposition assessment, and VH(TM) IVUS plaque composition analysis.
Volcano IVUS will also be highlighted in GE Healthcare's booth. GE's "InnovaŽ IVUS" is based on Volcano's s5i, and offers clinicians a deeper level of integration. With Innova IVUS, patient data transfers automatically between Innova and the s5i, and IVUS commands are integrated directly into Innova Central, GE's bedside control device. Additionally, when the case is complete, IVUS and angio can be archived in the same "patient jacket", making future data retrieval faster and easier.
The Volcano s5i 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 s5i has also been tested for compatibility with eleven different DICOM providers. The Volcano s5i will also be on display at the Phillips, Siemens and Toshiba booths at the ACC.
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 ChromaFloŽ. Internal DICOM networking provided by DICOM by Merge. 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 Coherent Tomography systems and catheters. Currently, more than 3,200 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 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.
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