April 4, 2007 -- RANCHO CORDOVA, Calif. -- Volcano Corporation (Nasdaq: VOLC) today summarized the role of Intravascular Ultrasound (IVUS) in a shifting Drug Eluting Stent (DES) market. Use of DES has decreased from 89% of PCIs in the U.S. down to an estimated 70% over the past year, driven by concerns over stent thrombosis causing heart attacks, and confidence in Bare Metal Stent (BMS) safety. In the same period, Volcano has seen an increase of 25% in IVUS revenue, demonstrating more reliance on detailed imaging to guide optimal DES and BMS placement.
Martin B. Leon, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York commented, "The negative press around acute and late stent thrombosis with DES has led physicians to reexamine the safety of stenting and their control over patient outcomes. Interventionalists are now taking two proactive measures to protect their patients; prolonged duration of dual anti-platelet therapy, and increased focus on stent placement technique. This drive to improve patient outcomes, and confirm proper stent expansion and apposition is driving the increased use of detailed imaging modalities like IVUS."
As part of a presentation at the CRT Meeting in Washington DC this month, Renu Virmani, MD, FACC, reiterated five contributing factors to late stent thrombosis that she uncovered as part of her post-mortem study on victims of sudden cardiac death. Dr. Virmani commented, "Histology data has shown that a significant number of sudden cardiac death victims exhibit similar predictors relating to stent placement. These include; discontinuation of anti-platelet therapy, stent mal-apposition, stent struts embedded into a necrotic core, hypersensitivity reaction to the implant, and ostial or bifurcation stenting. More advanced imaging modalities like IVUS can help address three of the five predictors, and in turn, may help reduce the risk of stent thrombosis."
Scott Huennekens, President and CEO of Volcano Corporation said, "Clearly, data from numerous major studies over the last six months have contributed to the heightened awareness surrounding stent placement technique and its role in patient safety. More physicians feel that prolonged dual anti-platelet therapy and IVUS guided stent placement can serve as the 'belt and suspenders' for DES. In circumstances where patients are not compliant with the physicians recommendation of anti-platelet medication, proper stent expansion and apposition becomes a more important part of the equation. In the end, stent placement technique is really the only factor that is fully within the control of the physician. I think the added confidence provided by IVUS imaging is directly correlated to the increase in Volcano catheter usage over the past 12 months."
Data suggests that IVUS can improve outcomes in bare metal stenting as well. Peter Fitzgerald, MD, PhD, Professor of Medicine and Engineering and Director of the Center for Cardiovascular Technology at Stanford University added, "There is substantial evidence that IVUS can help determine the appropriate strategy of stenting, medical therapy or bypass surgery. Additionally, evidence supports IVUS guided stenting with bare metal stents improves clinical outcomes. Many physicians may have lost sight of this fact with the advent of DES. This current moment of pause in the industry however has led many interventionalists back to established BMS platforms. Regardless of stent type, the value of IVUS guidance is certainly gaining momentum for both DES and BMS procedures."
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 and single-use
phased array and rotational IVUS imaging catheters. Volcano also has unique 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 2,500 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
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, among others, the statements regarding the potential benefits of the VH(TM) IVUS technology and Volcano's role of advanced imaging and diagnosis with IVUS are forward-looking statements involving risks and uncertainties. Forward-looking statements are based on current, preliminary expectations of Volcano management and are subject to risks and uncertainties, which may cause actual results to differ significantly from the statements contained herein. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date they are made. Volcano undertakes no obligation to revise or update any forward looking statements to reflect new information, events or circumstances after the date hereof, except as required by law. The potential risks and uncertainties that could cause actual results to differ from the results predicted are detailed in the risk factors contained in Volcano's Annual Report on Form 10-K and other filings made with the Securities and Exchange Commission.
Source: Volcano Corporation
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