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Boston Scientific Announces CE Mark For its TAXUS Paclitaxel-Eluting Stent System |
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NATICK, Mass., Jan. 21 -- Boston Scientific Corporation (NYSE: BSX - News) announced today that it has received CE Mark for its TAXUS paclitaxel-eluting stent system. The Company plans to launch the product next month in Europe and other international markets. It plans to launch the product in the United States later this year. "This is an historic day for our company and for the treatment of coronary artery disease," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "More than five years of hard work and good science have come together to provide clinicians and patients in Europe and other parts of the world a potentially revolutionary new therapy. We have now seen a large and diverse body of evidence that clearly indicates the delivery of polymer- based paclitaxel dramatically reduces restenosis. We are encouraged by this impressive data as well as by this approval to commercialize our first drug- eluting stent. We are further encouraged by recent data that demonstrates a beneficial edge effect, improvements in diabetic patients, and the absence of systemic levels of paclitaxel." "CE Mark for the TAXUS stent will now enable large numbers of patients to benefit from the great promise of paclitaxel-eluting stents," said Professor Antonio Colombo, M.D., EMO Centro Cuoro Columbus, Milan. "This is an exciting development that marks the beginning of a new era in the treatment of coronary artery disease." The TAXUS product will use the Express2 coronary stent system as its platform. The Express2 system was launched in the United States in mid- September and has been very well received. Since mid-September, Boston Scientific has approximately quadrupled its share of the U.S. stent market. The TAXUS program is a series of clinical studies designed to collect data on Boston Scientific's proprietary polymer-based, paclitaxel-eluting stent technology for reducing coronary restenosis, the growth of neointimal tissue within an artery after angioplasty and stenting. Polymer-based delivery of paclitaxel, the active component of the chemotherapeutic agent Taxol®, has demonstrated promising results in pre-clinical and clinical studies for reducing the processes leading to restenosis. The Company initiated the TAXUS program in 1997. Paclitaxel is a multifunctional drug with properties well suited for stent-based local drug delivery. The polymer allows for controlled delivery of the paclitaxel. The TAXUS I trial confirmed safety and reported zero thrombosis and zero restenosis. The TAXUS II trial studied the treatment of de novo coronary lesions and demonstrated both safety and efficacy using the slow- and moderate-release formulations and confirmed safety with no thrombosis. Significant improvements were seen for clinical, angiographic and intravascular measures of stent performance compared with the bare control stent. The TAXUS III trial, which studied the treatment of in-stent restenosis, also confirmed safety with no thrombosis. The TAXUS IV trial has completed enrollment and nine-month follow-up is underway. This study is designed to assess the safety and efficacy of a slow-release formulation to support regulatory filings for U.S. product commercialization. The TAXUS V trial has received conditional approval from the U. S. Food and Drug Administration to enroll patients and will study a higher risk patient population than TAXUS IV, including patients with smaller vessels and longer lesions. TAXUS VI is studying patients with complex coronary artery disease and recently completed enrollment. Boston Scientific has also initiated a transitional registry program (WISDOM) in a number of countries as part of a limited commercial launch of its TAXUS paclitaxel-eluting stent system. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices. The Company's products are used in a broad range of interventional medical specialties. This press release contains forward-looking statements. The Company wishes to caution the reader that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, the regulatory approval process, physician acceptance of new products, competitive product offerings and other factors described in the Company's filings with the Securities and Exchange Commission.
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