BOSTON SCIENTIFIC GETS FDA DEVICE EXEMPTION FOR ATLAS.
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|
|Date:||Sep 1, 2004|
|Previous Article:||FIRST PATIENT TREATED IN CLINICAL TRIAL OF EDWARDS LIFESTENT.|
|Next Article:||KENSEY NASH SUBMITS 510(K) APPLICATION FOR TRIACTIV SYSTEM.|
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