BOSTON SCIENTIFIC GETS FDA DEVICE EXEMPTION FOR ATLAS.Angiotech Pharmaceuticals, Inc. (NASDAQ NASDAQin full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ANPI ANPI Angiotech Pharmaceuticals Inc. (Vancouver, BC, Canada) ANPI Associazione Nazionale Partigiani d'Italia (Italian: National Association of Partisans) ; TSX: ANP ANP atrial natriuretic peptide. ANP atrial natriuretic peptide. ANP Atrial natriuretic peptide, see there ), Vancouver, has reported that its corporate partner, Boston Scientific Corp. has received an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and from the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) 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 con·form·a·ble adj. 1. Corresponding; similar: plans that are conformable to your wishes. 2. Quick to comply; submissive. 3. , 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 coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. . 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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