source: Boston Scientific Corporation

Boston Scientific Announces Final Results of its TAXUS III Paclitaxel-Eluting Stent Clinical Trial
Company announces approvals to market paclitaxel-eluting stent system,
plans to initiate registry program as part of limited commercial launch


Natick, MA and Paris (May 23, 2002) -- Boston Scientific Corporation (NYSE: BSX) today announced final, six-month results of its TAXUS III paclitaxel-eluting stent clinical trial. The Company made the announcement at the Paris Course on Revascularization, the largest interventional cardiology conference in Europe.

TAXUS III is a single-arm registry examining the feasibility of implanting up to two paclitaxel-eluting stents for the treatment of in-stent restenosis. The trial's main focus is safety, and the primary endpoint is 30-day MACE (Major Adverse Cardiac Events; including death, myocardial infarction and revascularization). This group represents patients with complex vascular disease having recurrent occlusion in a stent, who tend to have an increased probability of restenosis. The trial enrolled 30 patients. Twenty-eight were included in the follow-up analysis; 25 of whom completed quantitative coronary angiographic analysis.

The cumulative MACE data for patients out to 10 months reported six target lesion revascularizations (TLR's), one coronary artery bypass graft, and one peri-procedural, non-Q-wave myocardial infarction. There were no stent thromboses and no deaths. The pattern of TLR's was revealing. There were: two restenoses occurring in a segment (gap) between two paclitaxel-eluting stents, two TLR's performed that did not meet angiographic criteria for revascularization and instead were performed to improve stent apposition to the wall evident at initial implant, one restenosis in a bare stent adjacent to two paclitaxel-eluting stents, and one symptom-driven TLR. Quantitative coronary angiographic analysis of stented segments - including the distal and proximal edges - yielded an overall binary restenosis rate of 16 percent (4 of 25). Three of the four reflect restenosis in vessel segments not covered by a paclitaxel-eluting stent. Actual performance within the paclitaxel-eluting stent yields a restenosis rate of four percent (1 of 25).

"This is powerful data that provides further evidence that TAXUS™ paclitaxel-eluting stents hold great promise for the treatment of in-stent restenosis and coronary artery disease," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "This data highlights the importance of stent placement accuracy and complete coverage of the treated or diseased portion of the vessel with a paclitaxel-eluting stent. Further optimization in stent deployment and placement is likely to yield even better outcomes. This is a first and significant step toward expanding the role of TAXUS paclitaxel-eluting stents into more complex lesions."

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 United States 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. TAXUS IV has enrolled nearly 1,000 of its expected 1,172 patients. It is using the Express™ stent, a laser-cut, balloon-expandable stent developed exclusively by Boston Scientific.

Approvals/Registry Program
The Company also announced that it has received approvals from several governments to market its TAXUS™ Express™ paclitaxel-eluting coronary stent system. The company said it plans to initiate a transitional registry program (WISDOM) in a number of countries next week as part of a limited commercial launch. This multi-center, prospective, observational registry will collect and analyze "real world" data on the performance of a TAXUS paclitaxel-eluting stent system for the treatment of patients with coronary artery disease. (A registry program enlists large numbers of clinicians to document the performance of a specific therapy for a particular disease or condition.)

"We are very pleased with these approvals, and we're looking forward to beginning limited commercialization under the auspices of this registry," said Tobin. "We plan to gather additional information and experience from these cases and then progress to full commercialization later this year in Europe and other international markets, and in the United States next year. Safety has been our first priority, so we will proceed at a responsible and appropriate pace with this program. Rigorous science is a TAXUS hallmark, and our commitment to the highest levels of scientific excellence will be maintained in the WISDOM registry, as well as in the ongoing and upcoming TAXUS trials."

"Introducing a product through a registry program may represent a new era in the commercialization of interventional devices," said Dr. Alexandre Abizaid, M.D., Ph.D., Research Director, Institute Dante Pazzanese of Cardiology, Sao Paolo, Brazil, chairman of the registry program. "A registry allows the medical community to work with a sponsor to further advance initial learning gathered during clinical trials as a new product is transitioned from studies to full commercialization. We have been fortunate to be involved in the forefront of drug-eluting stent work and are excited to be participating in this registry."

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