Healthcare Industry News: stent thrombosis
News Release - October 22, 2007
Volcano Sponsors First Study Designed to Determine if IVUS Can Identify Patients at Risk for Stent Thrombosis and to Demonstrate the Benefit of IVUS Guidance for Procedural Outcome3,000 Patient Multi-center IVUS Sub-study Part of the Cardiovascular Research Foundation's ADAPT-DES Study to Quantify Causes and Cures of Drug Eluting stent thrombosis
SAN DIEGO, Oct. 22 (HSMN NewsFeed) -- Volcano Corporation (Nasdaq: VOLC ) [TCT Booth #2013 Level 2], a leading manufacturer of intravascular ultrasound (IVUS) and functional measurement (FM) technology, announced today its sponsorship of the first major study designed to examine the role of IVUS in ensuring accurate stent placement. The 3,000 patient IVUS sub-study is part of the Cardiovascular Research Foundation's (CRF) ADAPT-DES study (Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents), a prospective, multi-center registry of 11,000 (and up to 15,000) patients with coronary artery disease undergoing stent-assisted percutaneous coronary intervention (PCI) using drug-eluting stents (DES). The study's main objectives are to determine the frequency, timing and correlates (clinical, angiographic and IVUS) of DES thrombosis and the relationship of aspirin and/or clopidogrel hyporesponsiveness, and general platelet reactivity to early and late DES thrombosis.
"Although the benefits of IVUS have been anecdotally discussed by many interventional cardiologists and quantified in a number of published studies, the additive value of IVUS measures as independent predictors of stent thrombosis beyond the information present from clinical and angiographic variables has not been assessed in a prospective, multi-center registry," commented Gregg W. Stone, MD, Principal Investigator of ADAPT-DES and Chairman of the Cardiovascular Research Foundation. "The ADAPT-DES IVUS sub-study is expected to provide definitive evidence as to whether IVUS can identify patients at heightened risk for stent thrombosis."
The IVUS sub-study is expected to confirm the collaborative work of Dr. Antonio Colombo and his associates who identified IVUS parameters as independent predictors of stent thrombosis. In his findings, Dr. Colombo has demonstrated a high rate of IVUS-detected stent under-expansion and incomplete stent apposition (ISA) when bare-metal stents (BMS) have been implanted via angiographic guidance alone. Additionally, similar findings regarding stent under-expansion and residual edge stenoses have been discussed in numerous retrospective reports published since 2002 regarding acute and sub-acute BMS and DES thrombosis. Volcano's Eagle Eye® Gold IVUS catheters will be used in all sub-study patients at the initiation of the sub-study and in follow-up assessments. Analysis will include assessment of lesion morphology by using both traditional grayscale IVUS and Volcano's proprietary VH(TM) IVUS tissue characterization technology.
"The S.T.L.L.R. study* by Costa, et al, has shown that geographic miss is a contributing factor to poor stenting outcomes and stent thrombosis. We expect that the ADAPT-DES IVUS sub-study will confirm what many interventionalists already intuitively know-- that accurate stent placement really can reduce stent thrombosis and that IVUS is an effective, efficient way to optimize stent results," said Scott Huennekens, President & CEO, Volcano Corporation. "Volcano's sponsorship of this large sub-study represents a major commitment of resources for our company. Our leadership in sponsoring this clinical study again reinforces Volcano's commitment to advancing the field of interventional cardiology and improving patient safety and care."
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 and single-use phased array and rotational IVUS imaging catheters. Volcano also has unique advanced functionality options like VH(TM) IVUS tissue characterization and ChromaFlo(TM). 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. 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. Forward-looking statements involve risks and uncertainties and are based on management's current expectations. Actual results could differ materially from these forward-looking statements as a result of certain factors, including the risks and uncertainties related to the results of clinical studies and other factors discussed in Volcano's filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, which speak only as of the time they are made. Volcano undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, changed assumptions or otherwise. Actual results or experience could differ materially from the forward-looking statements.
* S.T.L.L.R stands for "The Impact of Stent Deployment Techniques on Clinical Outcomes on Patients Treated with the Cypher® Stent." Dr. Marco Costa was the lead investigator of this double-blinded clinical study of almost 1,500 patients treated with the Johnson & Johnson / Cordis drug-eluting CYPHER stent. The study was sponsored by Cordis, and findings were presented at TCT in 2006.
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