Boston Scientific Announces Two-Year Follow-Up Data from TAXUS IV Clinical Trial
and Washington, D.C. (September 29, 2004) -- Boston Scientific Corporation (NYSE: BSX) today announced two-year follow-up data from its TAXUS IV clinical trial. The benefits reported at 12 months -- for patients who received a paclitaxel-eluting stent compared to patients who received a bare-metal stent -- were maintained at two years. The Company made the announcement at the annual Transcatheter Cardiovascular Therapeutics symposium in Washington, D.C.

The results support safety and efficacy, as demonstrated by low rates of target lesion revascularization (retreatment rate, or TLR) that were maintained at two years. The TAXUS group reported a 5.6 percent (36/645) TLR rate compared with 17.5 percent (112/640) in the control group. The follow-up rate at two years was outstanding with 97 percent of patients returning. The rate of patients living free of TLR events was 94.4 percent at two years for the TAXUS group, as compared to 82.6 percent for the control group.

Results for diabetic patients (including oral and insulin-requiring diabetics) in the TAXUS group also showed that benefits were maintained at two years. The TLR rate for diabetics was 8.0 percent (12/150) compared to 22.0 percent (35/159) in the control group. Diabetic patients are more likely than non-diabetic patients to experience restenosis following angioplasty and stenting with bare-metal stents, and may stand to benefit substantially from drug-eluting stent technology. Diabetic patients are expected to represent approximately 40 percent of coronary interventions.

"The TAXUS IV results at two years are exceptional and support the long-lasting safety and efficacy of paclitaxel-eluting stent technology," said Gregg W. Stone, M.D., the study's Principal Investigator and Professor of Medicine, Columbia University Medical Center in New York. "These outcomes establish the durability of the TAXUS stent in a broad range of complex patients and blockages, representing a true medical advance. At two-year follow-up, the incremental benefits of having received the TAXUS stent system rather than a bare-metal stent continue to increase with no evidence of late catch-up apparent."

"This is the first drug-eluting stent trial in which analysis of additional TLR events between one and two years shows a significant benefit for patients treated with the TAXUS stent system," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "The data demonstrates a further increase of the overall TLR benefit compared to the control group."

TAXUS IV is a randomized, double-blind pivotal trial designed to assess the safety and efficacy of a paclitaxel-eluting coronary stent system in reducing restenosis in de novo lesions 10 - 28 mm in length and 2.5 - 3.75 mm in diameter. The study, which enrolled 1,326 patients at 73 sites in the United States, is using Boston Scientific's TAXUS™ Express™ coronary stent system. This system is built on the Express™ coronary stent system, which offers excellent deliverability to the treatment site and superb conformability to the vessel wall.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit:

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, intellectual property, and other factors described in the Company's filings with the Securities and Exchange Commission.