source: Boston Scientific Corporation

Boston Scientific Announces Start
of TAXUS V Clinical Trial
Company announces submission of second module of PMA application
for its TAXUS™ paclitaxel-eluting coronary stent system


NATICK, Mass., March 18 -- Boston Scientific Corporation (NYSE: BSX - News) announced today that it has started its TAXUS V clinical trial, which plans to evaluate more than 1,100 patients at up to 70 sites in the U.S. The first patients were enrolled earlier this month in the de novo lesion portion of the trial.

The TAXUS V clinical trial is an extension of the TAXUS IV clinical trial. TAXUS IV is a study designed to assess the safety and efficacy of a slow- release formulation to support regulatory filings for U.S. product commercialization. TAXUS V will study a higher-risk patient population than TAXUS IV, including patients with smaller vessels as well as those with longer lesions requiring overlapping stents.

"In the TAXUS V clinical trial, the utility of the Boston Scientific polymer-based, paclitaxel-eluting stent is being tested in some of the most challenging lesions that interventional cardiologists face - very small vessels and very long lesions," said Gregg Stone, M.D., Principal Investigator of TAXUS V and Director, Cardiovascular Research and Education, The Cardiovascular Research Foundation at the Lenox Hill Heart and Vascular Institute. "It is our hope and expectation that this technology will provide tremendous benefit to these patients whose prognosis is otherwise unfavorable."

The Company also announced that it has submitted the second module of its Pre-Market Approval (PMA) application for its TAXUS(TM) paclitaxel-eluting coronary stent system to the U.S. Food and Drug Administration (FDA). It is the second of five modules the Company plans to submit. The Company submitted the first module last month and plans to submit the fifth in June. Boston Scientific launched the TAXUS product in Europe and other international markets in February. It plans to launch the product in the United States late this year.

The TAXUS clinical program is a series of 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. Prior studies have demonstrated promising results by dramatically reducing restenosis. The proprietary polymer on the stent allows for controlled delivery of paclitaxel. Paclitaxel is a multi-functional microtubular inhibitor that controls platelets, smooth muscle cells and white blood cells, all of which are believed to contribute to restenosis. The Company initiated the TAXUS program in 1997.

The TAXUS I trial confirmed safety and reported zero thrombosis and zero restenosis. The TAXUS II trial studied the treatment of de novo lesions and demonstrated both safety and efficacy using the slow- and moderate-release formulations. 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, confirmed safety and reported no thrombosis. The TAXUS IV trial has completed enrollment and nine-month follow-up is underway. TAXUS VI is studying patients with complex coronary artery disease and has 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. A European post-market registry (Milestone II) is expected to begin soon following the recent European commercialization of the TAXUS product. The TAXUS system is the subject of an Investigational Device Exemption and is not currently available for commercial distribution in the United States.

The TAXUS product uses the Express2™ coronary stent system as its platform. The system offers excellent deliverability to the treatment site and outstanding conformability to the vessel wall.

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, third party intellectual property and other factors described in the Company's filings with the Securities and Exchange Commission.


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Milan Kofol (508-650-8569)
Investor Relations
Boston Scientific Corporation

Paul Donovan (508-650-8541)
Media Relations
Boston Scientific Corporation