source: Boston Scientific Corporation

Boston Scientific Announces 12-Month Follow-Up Data From TAXUS II Clinical Trial
Low six-month MACE and TLR rates maintained at one year

NATICK, Mass. and CHICAGO, March 30 -- Boston Scientific Corporation (NYSE: BSX - News) today announced 12-month follow-up data from its TAXUS II clinical trial. The results supported safety, as demonstrated by rates of Major Adverse Cardiac Events (MACE), specifically rates of target lesion revascularization (TLR). The benefits reported at six months for patients who received a paclitaxel-eluting stent were maintained at 12 months -- as evidenced by low MACE and TLR rates -- when compared to patients who received a bare-metal stent. The Company made the announcement at the 52nd Annual Scientific Session of the American College of Cardiology in Chicago.

TAXUS II is a 536-patient, 15-country, randomized, double-blind, controlled study of the safety and efficacy of a TAXUS™ paclitaxel-eluting coronary stent, in which two sequential cohorts of patients with standard risk, de novo coronary artery lesions were treated with different dose formulations.

At six months, TAXUS II reported an in-stent binary restenosis rate of 2.3 percent and an in-segment binary restenosis rate of 5.5 percent for the slow- release formulation cohort. The moderate-release formulation cohort reported a six-month in-stent binary restenosis rate of 4.7 percent and an in-segment binary restenosis rate of 8.6 percent. The rates for the control group at six months were 19 percent for in-stent binary restenosis and 22 percent for in- segment binary restenosis. In-segment includes the stent plus 5mm on either end of the stent. Both cohorts demonstrated an absence of edge effect.

Slow-release cohort: The slow-release formulation cohort reported an 8.5 percent MACE rate at six months with a 4.6 percent TLR rate. At 12 months, TAXUS II reported a 10.9 percent MACE rate with a 4.7 percent TLR rate. There were no additional TLRs reported from the slow-release cohort at 12 months.

Moderate-release cohort: The moderate-release formulation cohort reported a 7.8 percent MACE rate at six months with a 3.1 percent TLR rate. At 12 months, it reported a 9.9 percent MACE rate with a 3.8 percent TLR rate. There was only one additional TLR reported from the moderate-release formulation cohort at 12 months.

Combined, the control group reported a 21.7 percent MACE rate and 14.4 percent TLR rate at 12 months. The MACE-free survival rate difference between the control group and the TAXUS group increased over time, favoring the TAXUS group.

More than 95 percent of the patients enrolled in TAXUS II were included in the 12-month follow-up. The anti-platelet drug Plavix® was given for six months after the study stent was implanted. The 12-month results demonstrate a maintained benefit in TAXUS patients six months after the discontinuation of anti-platelet therapy.

"This 12-month data is our first opportunity to look at long-term follow- up in a large subset of TAXUS patients," said Professor Antonio Colombo, M.D., EMO Centro Cuoro Columbus, Milan, and the trial's Principal Investigator. "The results indicate sustained MACE and TLR rate reductions, which also extended to the trial's diabetic population. The 12-month data is extremely impressive and provides additional, consistent evidence of the safety and efficacy of paclitaxel-eluting stent technology."

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. 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 proprietary polymer on the stent allows for controlled delivery of paclitaxel.

The TAXUS I trial confirmed safety and reported zero thrombosis and zero restenosis. The TAXUS III trial, which studied the treatment of in-stent restenosis, confirmed safety and reported no thrombosis. The TAXUS IV trial is designed to assess the safety and efficacy of a slow-release formulation to support regulatory filings for U.S. product commercialization. It has completed enrollment and nine-month follow-up is underway. The TAXUS V trial is an extension of TAXUS IV, and it is studying higher risk patients including those with smaller vessels as well as those with longer lesions requiring overlapping stents. 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 post-market registry (Milestone II) has recently begun, following the commercialization of the TAXUS product in Europe and other international markets. The TAXUS system is the subject of an Investigational Device Exemption and is not currently available for commercial distribution in the United States. The U.S. Food and Drug Administration recently granted the TAXUS system "expedited review" status. Granting of expedited review status means that the application is designated to receive priority review before other pending applications.

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.

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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Boston Scientific Corporation

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