Healthcare Industry News: STENT Thrombosis
News Release - December 7, 2006
Volcano Corporation Announces Collaboration With Stanford University, Cardialysis and Cardiovascular Research Foundation Core Labs to Facilitate In-Depth IVUS Studies of Drug Eluting Stent Safety and Performance
Agreement Enables DES Studies Conducted With Three Leading Core Labs to Have Access to IVUS Imaging Catheters at No Added Cost to Stent ManufacturersRANCHO CORDOVA, Calif., STANFORD, Calif., ROTTERDAM, The Netherlands, and NEW YORK, Dec. 7 (HSMN NewsFeed) -- Volcano Corporation (Nasdaq: VOLC ), Stanford University, Cardialysis and Cardiovascular Research Foundation (CRF) today announced a collaboration whereby Volcano has agreed to provide intravascular ultrasound (IVUS) catheters free of charge for use in pivotal Drug Eluting Stent (DES) clinical trials. This offer will be made available to stent manufacturers utilizing the core lab services of Stanford, Cardialysis or CRF in trials where IVUS images and data are planned to be collected in 100% of patients at enrollment and at pre-determined follow-up periods.
The collaboration between Volcano and the highly respected core labs at Stanford, Cardialysis and CRF was orchestrated with the interventionalists guiding the core labs, Dr. Peter Fitzgerald, Dr. Patrick Serruys, Dr. Martin Leon and Dr. Gary Mintz.
The goal of the collaboration is to provide the stent industry, physicians and patients a more in-depth understanding of the complex phenomenon of STENT Thrombosis and the most definitive, expeditious answers to questions surrounding the long-term safety of current and next generation DES. In particular, IVUS is designed to precisely visualize late stent mal-apposition (when the coronary vessel grows away from the implanted stent months or years after deployment), which is emerging as a leading suspect in the search for the cause of late STENT Thrombosis in DES.
Comments From Collaborating Physicians:
According to Martin B. Leon, MD, Chairman of the Cardiovascular Research Foundation, and Associate Director of the Center for Interventional Vascular Therapy (CIVT) at Columbia University Medical Center, New York City, IVUS is the only imaging modality available today that provides sufficient information about the interaction between the stent and the coronary vessel. "We have always insisted that at least a sub-group of patients receive IVUS imaging at index and follow-up. Unfortunately, the sample size has apparently not been large enough to truly understand the safety profiles of these stents. With this agreement between Volcano, CRF and the other top core labs, we will now have the information at our disposal to fully and completely characterize the performance and safety of these important, state-of-the-art DES."
Patrick Serruys, MD, head of the interventional department at Erasmus University, Heartcenter Rotterdam, The Netherlands commented: "Prior clinical trials of DES have had important limitations in terms of the length of follow-up and the percentage of cases where follow-up IVUS images were available. As a result, we had to look to major adverse cardiac event (MACE) rates as an indication of the long-term safety of these devices. A better, more thoughtful and scientific approach is to view the IVUS images at index and follow-up in all patients in the trials. This should provide us with an acceptably large sample size upon which to determine which stents are safe, and which need additional refinement. Only in this way will we be able to understand the true safety profile of these complex DES devices."
Peter Fitzgerald, MD, PhD, Professor of Medicine and Engineering and Director of the Center for Cardiovascular Technology at Stanford University commented: "Angiography does not allow you to visualize late stent mal-apposition. We now believe that late acquired stent mal-apposition is a key suspect in the hunt for the cause of rare, but devastating late STENT Thrombosis in DES. IVUS is widely available and clearly and easily visualizes late stent mal-apposition. With access to free IVUS catheters, we are now able to make a very compelling argument to all DES manufacturers that the IVUS data should be collected in 100% of DES study patients, even if the IVUS information isn't required to be utilized by the interventionalist when implanting the device. Without IVUS data in the vast majority of the patients, I fear that DES trials would otherwise have to become so large (in terms of number of patients enrolled) and/or have such a long duration (longer follow-up period), that the innovation in this field would come to a standstill. I applaud Volcano for its vision and commitment in working with us to put this collaboration in place."
Comments From Management:
Scott Huennekens, President and CEO of Volcano Corporation explained the rationale for agreeing to participate in this collaboration. "Public and physician concern over the safety of DES has the potential to cast a shadow over the entire field of interventional cardiology -- a field which has brought incredible advances in cardiac care and has improved (and saved) the lives of millions. In looking at the preliminary data, it became clear to us that late stent mal-apposition and other anatomical factors were likely causes or clues to understand emerging reports about increased rates of STENT Thrombosis in DES. Since IVUS is the only technology practically capable of studying (with sufficient resolution and detail) the response of large numbers of live patients to DES, we entered into discussions with the scientists and physicians leading the top core labs as well as with the management of leading DES manufacturers. As a result of these discussions, we have agreed to a collaboration whereby Volcano will offer to provide IVUS catheters free of charge for pivotal DES studies where 100% of patients are scheduled for IVUS data collection at index and follow-up."
About Volcano Corporation
Volcano Corporation, which completed its IPO in June 2006, offers a broad suite of devices that 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 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 2,300 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 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. 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 successful execution of collaboration agreements and relationships, ease of product use, the availability or results of clinical trial and collaboration activities, the performance of the company's IVUS systems, customer acceptance and use of the company's products and technologies, the outcome of final data relating to clinical studies, the role of IVUS technology in optimizing stent placement and the role of IVUS in clarifying atherosclerotic disease process and guiding interventional and system therapies 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 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.
Source: Volcano
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