source: Boston Scientific Corporation

Boston Scientific Announces FDA Authorization for Full Enrollment of TAXUS IV Clinical Trial


Natick, MA (May 2, 2002) -- Boston Scientific Corporation (NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA) has authorized full enrollment of its TAXUS IV clinical trial.

The FDA action allows the trial to enroll its full complement of up to 1172 patients at up to 80 sites. In March the FDA granted Boston Scientific an Investigational Device Exemption (IDE) to begin the trial. At the time, the FDA authorized enrollment of up to 400 patients at up to 40 sites. Enrollment of the 400 patients is scheduled to be completed this week.

The fourth trial in the TAXUS drug-eluting stent program, TAXUS IV is a pivotal study designed to collect data to support regulatory filings for U.S. product commercialization. The prospective, randomized, double-blind trial is designed to assess the safety and efficacy of a slow-release dose formulation paclitaxel-eluting TAXUS™ stent system for the treatment of coronary restenosis.

"The FDA's authorization to fully enroll the TAXUS IV trial marks another step toward realizing the promise of paclitaxel-eluting stents as a safe and effective treatment for coronary artery disease," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "We're looking forward to the results from this trial, and we're optimistic that they will be similar to the encouraging ones reported in earlier TAXUS trials."

The TAXUS program is a series of clinical studies designed to collect data on Boston Scientific's proprietary paclitaxel-eluting stent technology for reducing coronary restenosis, the growth of tissue within an artery after angioplasty and stenting. Paclitaxel, the active component of the popular chemotherapeutic agent Taxol®, has demonstrated promising results in pre-clinical and clinical studies for reducing the processes leading to restenosis. The comprehensive TAXUS program positions Boston Scientific to launch paclitaxel-eluting stents in Europe this year and in the U.S. in 2003.

The TAXUS I trial confirmed safety and reported zero thrombosis and zero restenosis. The TAXUS II trial completed enrollment of 537 patients in January, and the patients are now in the follow-up period. Preliminary safety data from TAXUS II presented in March at the American College of Cardiology annual meeting provided further support for the safety of paclitaxel-eluting stents. The TAXUS III trial studied the treatment of in-stent restenosis and also confirmed safety with no thrombosis. The study reported encouraging efficacy data. The TAXUS IV trial is using the Express™ stent, a laser-cut, balloon-expandable stent developed exclusively by Boston Scientific.

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

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