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Boston Scientific Completes Enrollment of |
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NATICK, Mass., Jan. 16 -- Boston Scientific Corporation (NYSE: BSX - News) announced today that it has completed enrollment of its TAXUS VI clinical trial. TAXUS VI is an international trial studying 448 patients with complex coronary artery disease at 44 sites. It is designed to establish the safety and efficacy of the moderate-release formulation in the treatment of longer lesions (greater than or equal to 18 mm in length). The TAXUS VI trial is using the Company's internally developed Express(TM) stent. The trial -- which includes the use of multiple stents -- has a primary endpoint based on nine-month target vessel revascularization. "This is another significant step forward for our drug-eluting stent program, and it will contribute to the growing body of data collected from our previous TAXUS trials," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "We are confident that TAXUS VI will build on previous trial results that support our long-held belief that polymer-based, paclitaxel-eluting technology will be a safe and effective treatment for coronary artery disease." 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. 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(TM) paclitaxel-eluting stent system. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose 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 of this press release 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, commercialization of new technologies and other factors described in the Company's filings with the Securities and Exchange Commission.
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