source: Boston Scientific Corporation

Boston Scientific Announces Final Results of its TAXUS II Drug-Eluting Stent Clinical Trial
Study reports in-stent restenosis rate of 2.3 percent, in-segment rate of 5.5 percent

Natick, MA and Washington, D.C. (September 26, 2002) -- Boston Scientific Corporation (NYSE: BSX) today announced final, six-month results of its TAXUS II paclitaxel-eluting stent clinical trial. It is the Company's first large drug-eluting stent trial, and the results convincingly demonstrated both safety and efficacy in reducing coronary restenosis. The results were consistent with those of other TAXUS trials and were in line with expectations. The Company made the announcement at the annual Transcatheter Cardiovascular Therapeutics symposium in Washington, D.C.

The TAXUS II trial consists of two sequential cohorts: a slow-release formulation and moderate-release formulation. For both cohorts, the significant reduction in the primary endpoint -- six-month, percent in-stent volume obstruction as assessed by intravascular ultrasound (IVUS) -- indicates that polymer-based, local delivery of paclitaxel interrupts the restenotic process. Significant improvements were also shown in clinical and angiographic endpoints.

Slow-release cohort: The slow-release formulation cohort reported an in-stent binary restenosis rate of 2.3 percent (3/128) and an in-segment binary restenosis rate of 5.5 percent (7/128). Of the three in-stent restenoses in the slow-release cohort, one occurred in an adjacent non-study (bare metal) stent. The control group reported an in-stent binary restenosis rate of 17.9 percent (24/134) and an in-segment binary restenosis rate of 20.1 percent (27/134). The slow-release cohort reported an 8.5 percent Major Adverse Cardiac Events (MACE) rate at six months with a 4.6 percent target lesion revascularization (TLR) rate. The control group reported a 19.5 percent MACE rate at six months with a 12.0 percent TLR rate.

Moderate-release cohort: The moderate-release formulation cohort reported an in-stent binary restenosis rate of 4.7 percent (6/128) and an in-segment binary restenosis rate of 8.6 percent (11/128). Of the six binary restenosis cases in the moderate-release cohort, four occurred in adjacent non-study stents and one in the gap between two stents. The control group reported an in-stent binary restenosis rate of 20.2 percent (26/129) and an in-segment binary restenosis rate of 23.8 percent (31/130). The moderate-release cohort reported a 7.8 percent MACE rate at six months with a 3.1 percent TLR rate. The control group reported a 20.0 percent MACE rate at six months with a 14.6 percent TLR rate.

Excluding non-study stents and gaps: Excluding restenosis occurring in non-study stents (5) and in gaps between stents (1), the combined in-stent restenosis rate for the two cohorts is 1.2 percent (3/256).

Incidence of aneurysms (1.5 percent in each treatment group) was similar between the paclitaxel-coated stent and the bare metal stent, and is consistent with previous reports. These events appear to be associated with dissections and did not lead to any clinical consequences.

"These results are compelling evidence of the safety and effectiveness of TAXUS paclitaxel-eluting stents for the treatment of de novo coronary disease," said Professor Antonio Colombo, M.D., the trial's Principal Investigator. "Three Boston Scientific trials have now reported highly reproducible results, establishing safety as a function of MACE, and efficacy as a function of quantitative coronary angiography and IVUS measurements. The consistency of these clinical, angiographic and IVUS findings indicates a predictable biological response and improved patient outcomes with TAXUS paclitaxel-eluting stents. In addition to impressive reductions in restenosis rates, we also saw a beneficial edge effect, as indicated by greater lumen diameters and less late loss. The restenosis rates are already so low at the edges that further differences are not seen in this sample size."

"I am greatly encouraged by these excellent results, particularly the very low restenosis rates and the beneficial edge effect," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "These results are the clearest indication to date that polymer-based delivery of paclitaxel has the potential to be a breakthrough therapy for coronary artery disease. Today we can say with even more confidence that physicians and their patients will have access to this important new treatment alternative later this year in Europe and next year in the United States."

TAXUS II is a 536-patient randomized, double-blind, multi-center, international study designed to assess the safety and efficacy of a paclitaxel-eluting coronary stent in reducing restenosis in de novo lesions up to 12 mm in length and 3.5 mm in diameter.

Data from this trial is being used to support the Company's submission for a CE Mark for its TAXUS paclitaxel-eluting stent system, which will use an Express™ stent, the internally developed stent approved earlier this month by the U.S. Food and Drug Administration and granted CE Mark last year.

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 neointimal 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 Company initiated the TAXUS program in 1997.

The TAXUS I trial reported zero thrombosis and zero restenosis. Clinical follow-up through 12 months continues to show favorable results with no additional TLR's and no subacute thrombosis six months after termination of Plavix®, an anti-platelet therapeutic commonly used following stenting procedures.

The TAXUS III trial studied the treatment of in-stent restenosis and also confirmed safety with no thrombosis. The study reported encouraging efficacy data as well.

The TAXUS IV trial is studying more than 1,200 patients in the United States, assessing the safety and efficacy of the slow-release formulation. This trial is using the Express stent.

The TAXUS VI trial is an international trial studying more than 400 patients with complex coronary artery disease. It is designed to establish the safety and efficacy of the moderate-release formulation.

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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Boston Scientific Corporation

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Boston Scientific Corporation