RANCHO CORDOVA, Calif., Oct. 21 /PRNewswire-FirstCall/ -- Volcano Corporation today outlined its comprehensive presence at the 2006 TCT Conference in Washington, D.C. from October 22nd to the 27th. Volcano related events include PROSPECT and VH Registry clinical study data, live case broadcasts, a Breakfast Symposium and Evening Receptions, expanded booth presence, and updates on Volcano’s AIM(TM) Angio IVUS Mapping technology, GE Healthcare’s Innova IVUS program, and launch of the Revolution(TM) 45 MHz High Frequency IVUS Imaging Catheter. Volcano’s products are designed to add clarity to pre-intervention strategy and confidence in the post-intervention outcome, and to do so in a fast, simple manner that does not add unwarranted complexity or time to the procedure.
Clinical Trial Update
Gregg W. Stone, M.D., Principle Investigator of PROSPECT (Providing Regional Observations to Study Predictors of Events in the Coronary Tree) will present baseline demographic and imaging data from the initial 250 patients on Monday, October 23rd at two o’clock PM in the main arena. Complete enrollment of the 700 acute coronary syndrome patient population was announced on August 30th of this year, and follow-up of patients experiencing events will be tracked for up to five years. “As the first prospective natural history study examining whether novel blood and imaging tests are able to identify patients at risk for future death and heart attack, PROSPECT promises to provide groundbreaking data critical to understanding the progression of coronary artery disease, and represents the first step toward identifying patients at high risk who may benefit from preventative therapies,” said Dr. Stone. PROSPECT is a global study with over 40 centers participating worldwide, aimed at determining the likelihood of specific plaque types to cause heart attacks.
The Volcano VH Registry has now completed enrollment of over 3,000 patients worldwide, aimed at correlating plaque characteristics with patient demographics, clinical presentation, and cardiac risk factors. Seven separate abstracts pooled from the VH Registry data will be presented throughout the week of TCT highlighting correlations in diverse patient subsets.
Product Launches
Volcano is pleased to announce the launch of the Revolution(TM) 45 MHz Rotational IVUS Imaging catheter in the US and Europe. The Revolution is Volcano’s first high-frequency coronary imaging catheter and operates at a 45 MHz frequency, providing increased resolution and clarity in the near-field. The Revolution can accommodate a 15 cm pullback inside of a stationary, protective sheath, and also includes a reinforced proximal shaft, robust locking mechanism, and RFID catheter-to-console communication that is designed for consistent, reliable image quality.
The Revolution is designed to operate with the new SpinVision(TM) Patient Interface Module (PIM). The SpinVision is a completely reusable pullback device that operates inside of a custom sterile barrier, and provides the motor-drive and power to spin the IVUS transducer and create the ultrasound pulse. The SpinVision is a balanced, low center-of-mass device designed for increased sterile field stability and also houses the key IVUS console controls to allow initiation and recording of images or video loops from the sterile field. The SpinVision is immediately available on the Volcano IVG platform, and will be on display at the Volcano TCT booth.
Product Approvals
Volcano’s AIM(TM) Angio IVUS Mapping technology has been cleared by the FDA and will be showcased at TCT in live case broadcasts, and at the Volcano booth. AIM co-registers the detailed IVUS cross section to the 2-D or 3-D angiographic road map allowing clinicians to see both images ‘linked’ and displayed side-by-side. Physicians can now combine the lumen information and spatial orientation of the vessel from traditional angiography with the detailed plaque measurement information and tissue classification from IVUS and VH(TM) IVUS.
Live Case Transmissions
During the week of TCT, Volcano will collaborate with physicians globally to provide a full schedule of live case demonstrations of Volcano’s innovative intravascular imaging and intracoronary physiology products. This will include transmissions featuring Volcano’s fast and easy-to-use s5(TM) family of IVUS consoles, including Volcano’s s5i customized integrated cath lab format and GE Healthcare’s unique-in-the-industry Innova IVUS system. Other products planned for use in live case transmission will include AIM(TM) Angio IVUS Mapping technology, Eagle Eye(TM) Gold and Revolution(TM) coronary IVUS imaging catheters, VH(TM) IVUS Tissue Characterization, the IVUS Guided Medtronic Pioneer catheter and other Volcano peripheral vascular IVUS imaging catheters. Sites are also expected to utilize the Volcano ComboWire(TM) and ComboMap(TM) to explore the significance of lesions prior to confirming their interventional strategy.
Breakfast Symposium
Volcano is also sponsoring a Breakfast Symposium this year, highlighting the role of IVUS in guiding optimal Drug Eluting Stent placement. The symposium will be held on Thursday, October 26th (7am to 8am, room 144B Street Level). The session will be chaired by Gary Mintz, MD, and will include talks and case presentations by Mike Foster, MD, and Habib Samady, MD, FACC.
Expanded Booth Presence to Demonstrate New Products
Volcano will feature an expanded product expo area in the commercial exhibit spaces at TCT. Please visit us in booth #1016 at TCT for a complete tour of Volcano’s newest intravascular imaging and intracoronary physiology products.
GE Healthcare’s Technology Leadership Reception
GE is hosting an Evening Reception to discuss recent advances in invasive and non-invasive imaging. This will include a featured presentation by John Hodgson, M.D. GE recently launched Innova IVUS, its custom s5i configuration. Innova IVUS is commercially available to new and existing GE Healthcare customers. The reception will be held at the Renaissance Hotel, located across the street from the Convention Center, on Sunday, October 22nd, from 6:30-9:00 PM.
About Volcano Corporation
Volcano Corporation, which completed its IPO in June 2006, offers a broad suite of devices that facilitate endovascular procedures. Volcano’s products enhance the diagnosis of vascular and structural heart diseases and guide optimal therapies. The company’s IVUS (intravascular ultrasound) product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab and single-use phased array and rotational IVUS imaging catheters. Volcano also has unique advanced functionality options like VH tissue characterization and IVUS and angiography co-registration. Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires. Currently, more than 2,000 Volcano IVUS and FM systems are installed worldwide, with nearly half of its revenues coming from outside the United States. 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. Statements in this press release regarding Volcano’s business that are not historical facts may be “forward-looking statements” that involve risks and uncertainties. Specifically statements regarding the introduction and commercialization of new products, shortened procedure time, ease of product use, the availability or results of clinical trial activities, the performance of the company’s IVUS systems and customer acceptance and use of the company’s products and technologies are forward-looking statements that involve risks and uncertainties. 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 from the statements contained herein. The potential risks and uncertainties that could cause actual results to differ from the results presented are detailed in the section, “Risks Related to Our Business and Industry,” in the company’s 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 publicly 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.
Volcano Corporation
CONTACT: Scott Huennekens, President & CEO of Volcano Corporation,+1-916-638-8008, or Michel Lussier, Vice President of Volcano Europe SA/NV,+32-475-80-00-97
Web site: http://www.volcanocorp.com/
