TAXUS V IVUS results support safety and efficacy in most challenging lesions and highest-risk patients
24 Mai 2005 - 6:30PM
PR Newswire (US)
TAXUS V IVUS results support safety and efficacy in most
challenging lesions and highest-risk patients VANCOUVER and PARIS,
FRANCE, May 24 /PRNewswire-FirstCall/ -- Angiotech Pharmaceuticals,
Inc. (NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP) corporate partner, Boston
Scientific ("BSC"), today announced intravascular ultrasound (IVUS)
follow-up data from BSC's TAXUS V clinical trial, supporting the
safety and efficacy of the TAXUS(R) Express(2)(TM)
paclitaxel-eluting coronary stent system for the treatment of
coronary artery disease in the most challenging lesions and
highest-risk patients ever studied in a randomized, controlled
clinical trial in the United States. TAXUS V expands on the TAXUS
IV pivotal trial by studying a higher-risk patient population,
including patients with small vessels, large vessels and long
lesions requiring multiple overlapping stents. Analysis of the data
was presented by Neil Weissman, M.D., Director of Cardiac
Ultrasound and Ultrasound Core Laboratories at the Cardiovascular
Research Institute at Washington Hospital Center and Associate
Professor of Medicine at Georgetown University School of Medicine
in Washington, D.C. BSC made the announcement at the annual Paris
Course on Revascularization. BSC states that the results presented
are among the most comprehensive intravascular ultrasound (IVUS)
follow-up data of any drug-eluting stent randomized clinical trial.
IVUS technology provides views from inside a patient's blood
vessels, offering the most accurate visual confirmation of stent
deployment and vessel condition. "The lesions studied in TAXUS V
are some of the most difficult we confront in interventional
cardiology," said Dr. Weissman. "The TAXUS V IVUS data provides an
especially rich source of information on the excellent performance
of the TAXUS system. The uniform neointimal suppression across both
single stents and multiple overlapping stents attests to the
efficacy of TAXUS across a wide range of lesion lengths." BSC
reports that the IVUS data confirmed the consistent performance of
the TAXUS system in high-risk patients and complex lesions.
Patients in the TAXUS group exhibited consistent neointimal
suppression out to nine-months across the entire length of the
lesions, resulting in stable late loss with sustained clinical
benefit over the control group. Quantitative IVUS measurements
revealed significant improvements for percent in-stent net volume
obstruction (13.2 percent in the TAXUS group versus 31.8 percent in
the control group; P less than 0.0001). Consistency of outcomes was
maintained regardless of lesion length or single versus multiple
stenting, and a detailed millimeter-by-millimeter analysis
demonstrated consistent neointimal suppression along the total
length of the stent. Efficacy and safety results remained
consistent with findings from other ongoing TAXUS clinical trials,
including TAXUS II, IV and VI. TAXUS V represents the longest
lesions ever studied with IVUS data in a clinical trial for
drug-eluting stents. TAXUS V is a randomized, double-blinded trial
that enrolled 1,172 patients at 66 sites in the United States,
assessing the safety and efficacy of a slow-release formulation
paclitaxel-eluting coronary stent system in reducing restenosis in
de novo lesions 10 - 46 mm in length and 2.25 - 4.0 mm in diameter.
The Company previously announced in March that the trial met its
primary endpoint of nine-month target vessel revascularization
(symptom-driven repeat revascularization of the target vessel, or
TVR), as well as all secondary endpoints. BSC acquired worldwide
exclusive rights from Angiotech to use paclitaxel to coat its
coronary stent products and has co-exclusive rights to other
vascular and non-vascular products. Vancouver-based Angiotech
Pharmaceuticals, Inc. is a specialty pharmaceutical company
pioneering the combination of pharmaceutical compounds with medical
devices and biomaterials to both create novel solutions for poorly
addressed disease states and dramatically improve surgical
outcomes. To find out more about Angiotech Pharmaceuticals, Inc.
(NASDAQ:ANPINASDAQ:TSX:NASDAQ:ANP), please visit our website at
http://www.angiotech.com/. Statements contained herein that are not
based on historical or current fact, including without limitation
statements containing the words "anticipates," "believes," "may,"
"continue," "estimate," "expects," "may" and "will" and words of
similar import, constitute "forward-looking statements" within the
meaning of the U.S. Private Securities Litigation Reform Act of
1995. Such forward-looking statements involve known and unknown
risks, uncertainties and other factors that may cause the actual
results, events or developments to be materially different from any
future results, events or developments expressed or implied by such
forward-looking statements. Such factors include, among others, the
following: general economic and business conditions, both
nationally and in the regions in which the Company operates;
technology changes; competition; changes in business strategy or
development plans; the ability to attract and retain qualified
personnel; existing governmental regulations and changes in, or the
failure to comply with, governmental regulations; liability and
other claims asserted against the Company; and other factors
referenced in the Company's filings with the United States
Securities and Exchange Commission or the Canadian securities
regulators. Given these uncertainties, readers are cautioned not to
place undue reliance on such forward-looking statements. The
Company does not assume the obligation to update any
forward-looking statements. CONTACTS: Todd Young, Angiotech
Pharmaceuticals (Analysts & Investors) (604) 221-7676 ext 6933
Rui Avelar, Angiotech Pharmaceuticals, Inc. (Analysts) (604)
221-7676 ext 6996 Eric Starkman, Starkman & Associates (Media)
(212) 252-8545 ext 12 DATASOURCE: Angiotech Pharmaceuticals, Inc.
CONTACT: Todd Young, Angiotech Pharmaceuticals, (Analysts &
Investors), (604) 221-7676 ext 6933; Rui Avelar, Angiotech
Pharmaceuticals, Inc., (Analysts), (604) 221-7676 ext 6996; Eric
Starkman, Starkman & Associates (Media), (212) 252-8545 ext 12
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