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BOSTON SCIENTIFIC GETS FDA DEVICE EXEMPTION FOR ATLAS.

Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI; TSX: ANP), Vancouver, has reported that its corporate partner, Boston Scientific Corp. 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.

For more information, visit http://www.angiotech.com or call 604/221-7676, ext. 6996.
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Publication:Biotech Equipment Update
Geographic Code:1CANA
Date:Sep 1, 2004
Words:302
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