Navigation Links
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 Outcome
Date:10/22/2007

3,000 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 /PRNewswire-FirstCall/ -- 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(R) 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.

Forward-Looking Statements

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(R) 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.


'/>"/>
SOURCE Volcano Corporation
Copyright©2007 PR Newswire.
All rights reserved

Related medicine technology :

1. Data Available From Erbitux Phase III Study in First-Line Treatment of Advanced Lung Cancer
2. Pixantrone Combination Therapy for First-line Treatment of Aggressive Non-Hodgkins Lymphoma Results in Reduction in Severe Toxicities Including Heart Damage When Compared to Doxorubicin-based Therapy
3. Genzyme Announces Data from First Phase 3 Study of Tolevamer in Patients with C. difficile Associated Diarrhea
4. Ablynx Announces Interim Results of First Nanobody Phase I Study of ALX-0081 (ANTI-VWF)
5. Advanced Life Sciences Announces Supplemental Efficacy Data from First Pivotal Phase 3 Pneumonia Clinical Trial
6. Advanced Life Sciences to Host Conference Call to Discuss Data From Cethromycins First of Two Phase 3 Pneumonia Trials
7. First Phase II Short-Term Study on Dapagliflozin Shows Results on Safety, Tolerability and Glycemic Markers in Subjects With Type 2 Diabetes
8. Advanced Cell Technology Develops First Human Embryonic Stem Cell Line without Destroying an Embryo
9. First Demonstration of nanoImmunology: a Nanomaterials-based Therapeutic Approach to Treat Allergy
10. First single breast cancer study to show significant survival benefit for women switching from tamoxifen to Arimidex
11. Mymetics HIV Vaccine Demonstrates First-Ever Production of Neutralizing IgA Antibodies in Non-Human Primate Model
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/2/2017)... , Oct. 2, 2017  AllianceRx Walgreens Prime, ... formed by Walgreens and pharmacy benefit manager Prime Therapeutics ... new brand, which included the unveiling of new signage ... , as well as at a few other company-owned ... new brand to patients, some of whom will begin ...
(Date:9/27/2017)... , Sept. 27, 2017  Commended for their devotion ... notable awards. Ranked as number one in the South Florida ... time in Inc. 5000 yearly list, the national specialty pharmacy ... Armando Bardisa will soon be honored by SFBJ ... Set to receive his award in ...
(Date:9/22/2017)... 2017  As the latest Obamacare repeal effort moves ... (R-LA) and Lindsey Graham (R-SC) medical ... device industry is in an odd place.  The industry ... excise tax on medical device sales passed along with ... patients, increased visits and hospital customers with the funding ...
Breaking Medicine Technology:
(Date:10/13/2017)... NY (PRWEB) , ... October 13, 2017 , ... Ellevate ... people in business to advocate for action towards gender equality at their inaugural Summit ... from around the globe, and reached a social audience of over 3 million. To ...
(Date:10/13/2017)... Fairfax, VA (PRWEB) , ... October 13, 2017 ... ... provider of DevOps and Agile Software Development, has been awarded a contract by ... (EATS) Blanket Purchase Agreement (BPA) aims to accelerate the enterprise use of Agile ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... treating sleep apnea using cutting-edge Oventus O2Vent technology. As many as ... disorder characterized by frequent cessation in breathing. Oral appliances can offer significant relief ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics ... PhD, FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s ... of Morris F. Collen, a pioneer in the field of medical informatics, this prestigious ...
(Date:10/12/2017)... ... ... HMP , a leader in healthcare events and education, today announced that ... for ‘Best B-to-B Healthcare Website.’ Winners were announced during the Eddie & Ozzie Awards ... recognizes editorial and design excellence across a range of sectors. This year’s program included ...
Breaking Medicine News(10 mins):