source: Boston Scientific Corporation

Boston Scientific Announces 30-Day Safety Data from its TAXUS IV Drug-Eluting Stent Clinical Trial
Company announces additional data from TAXUS II trial indicating significant improvements for diabetic patients

Natick, MA and Washington, D.C. (September 28, 2002) -- Boston Scientific Corporation (NYSE: BSX) today announced 30-day safety data from its TAXUS IV clinical trial. The trial is studying 1,326 patients at 72 sites in the United States, assessing the safety and efficacy of a slow-release formulation paclitaxel-eluting stent. The Company made the announcement at the annual Transcatheter Cardiovascular Therapeutics symposium in Washington, D.C.

The randomized, double-blind, pivotal trial is designed to assess the safety and efficacy of a paclitaxel-eluting coronary stent in reducing restenosis in de novo lesions 10 - 28 mm in length and 2.5 - 3.75 mm in diameter. The study is using the Express™ stent, Boston Scientific's internally developed stent approved earlier this month by the U.S. Food and Drug Administration and granted CE Mark last year.

The results supported safety, as demonstrated by MACE (Major Adverse Cardiac Events) rates, which are low and consistent with TAXUS I and II results. The MACE rates for the paclitaxel-eluting stent were similar to those for the control bare stent.

"This early data is very positive and provides further evidence that paclitaxel-eluting stents appear to be a safe treatment for coronary artery disease," said Dr. Gregg Stone, M.D., the trial's Co-Principal Investigator. "The efficacy of the TAXUS stent in reducing restenosis will be further explored with the presentation of the nine-month data next year."

The Company also announced additional analysis of its TAXUS II data, relating to the efficacy of a paclitaxel-eluting stent for reducing restenosis in diabetic patients. (The Company announced final, six-month results of the TAXUS II trial on September 26. The TAXUS II trial consists of two sequential cohorts: a slow-release formulation and a moderate-release formulation.) The analysis found a significant improvement in late loss for the diabetic population in the drug-eluting stent group compared to the bare stent control group. (Late loss is an angiographic measure of the long-term benefits of stenting.) In the slow-release cohort, late loss for the diabetic patients was 0.37 in the drug-eluting stent group and 0.90 in the control group (P = 0.004). In the moderate-release cohort, the late loss for the diabetic patients was 0.40 in the drug-eluting stent group and 0.80 in the control group (P = 0.01). The analysis also found a trend toward improvement in binary restenosis rates in diabetic patients in the drug-eluting stent group compared to those in the control group.

"This provides the first evidence in our program that diabetics benefit from paclitaxel-eluting stents," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "Despite the small sample, this data is very intriguing and holds great hope for diabetic patients. Diabetic patients experience far more restenosis following angioplasty and stenting, and they may stand to benefit dramatically from these improvements."

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

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