Angiotech Partner receives FDA approval for clinical trial of its Liberte(TM) paclitaxel-eluting coronary stent system
22 Juli 2004 - 7:16PM
PR Newswire (US)
Angiotech Partner receives FDA approval for clinical trial of its
Liberte(TM) paclitaxel-eluting coronary stent system Pivotal study
will assess safety and efficacy of next-generation drug-eluting
stent system VANCOUVER, July 22 /PRNewswire-FirstCall/ -- Angiotech
Pharmaceuticals, Inc. (NASDAQ: ANPI; TSX: ANP), today reported that
its corporate partner, Boston Scientific Corp. announced today that
it has received an Investigational Device Exemption from the U.S.
Food and Drug Administration (FDA) to begin its ATLAS clinical
trial. ATLAS is the first clinical trial using Boston Scientific's
new Liberte coronary stent as a platform for its paclitaxel-eluting
coronary stent system. TAXUS(TM) Liberte will be the next
generation to Boston Scientific's current paclitaxel-eluting stent
system, TAXUS(TM) Express(2)(TM). The Liberte stent, which has been
designed to further enhance deliverability and conformability,
particularly in challenging lesions, is currently available in
international markets in a bare metal version. Boston Scientific
states that the ATLAS trial is a pivotal study to collect data to
support regulatory filings for product commercialization. It is
designed to assess the safety and efficacy of a slow-release dose
formulation paclitaxel-eluting TAXUS Liberte stent system for the
treatment of coronary artery disease. The trial is scheduled to
enroll 822 patients at 60 sites in the United States, Canada,
Australia, New Zealand, Singapore, Hong Kong and Taiwan, as stated
by Boston Scientific. "I have found the Liberte bare metal stent to
be an excellent stent with superb conformability and
deliverability," said Keith Dawkins, M.D., Consultant Cardiologist,
Wessex Cardiothoracic Centre, Southampton University Hospital,
Southampton, England. "I am looking forward to Boston Scientific's
next-generation paclitaxel-eluting stent, which will use this
platform." Boston Scientific is a worldwide developer, manufacturer
and marketer of medical devices whose products are used in a broad
range of interventional medical specialties. Vancouver-based
Angiotech Pharmaceuticals, Inc., a specialty pharmaceutical company
focusing on drug-coated medical devices and biomaterials, is
dedicated to enhancing the performance of medical devices and
biomaterials through the innovative uses of pharmacotherapeutics.
To find out more about Angiotech Pharmaceuticals, Inc. (NASDAQ:
ANPI; TSX: 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" 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. FOR ADDITIONAL INFORMATION: Contact:
Rui Avelar, Angiotech Pharmaceuticals, Inc. (604) 221-7676 ext 6996
Media: Eric Starkman, Starkman & Associates (212) 252-8545 ext
12 DATASOURCE: Angiotech Pharmaceuticals, Inc. CONTACT: Rui Avelar,
Angiotech Pharmaceuticals, Inc., (604) 221-7676 ext 6996; Media:
Eric Starkman, Starkman & Associates, (212) 252-8545 ext 12
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