source: Boston Scientific Corporation

Boston Scientific Announces 30-Day Safety Data for the Complete Study Population of TAXUS IV Drug-Eluting Stent Clinical Trial
Company also announces 12-month clinical follow-up data from TAXUS

NATICK, Mass., Nov. 18 -- Boston Scientific Corporation today announced 30-day safety data for the complete study population of its TAXUS IV clinical trial. The trial is studying 1,326 patients at 74 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 meeting of the American Heart Association in Chicago.

In September, the Company announced 30-day safety data for 1,172 of the 1,326 patients. The additional 154 patients all had longer, more complex lesions.

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 up to 28 mm in length and up to 3.75 mm in diameter. The study uses the Express(TM) stent, Boston Scientific's internally developed stent approved in September by the U.S. Food and Drug Administration and granted CE Mark last year.

The results supported safety, as demonstrated by overall 30-day MACE (Major Adverse Cardiac Events) rates of only 3.0 percent. Stent thrombosis rates - another early indicator of safety - were less than 0.5 percent.

"This is the largest TAXUS study to date, and it reinforces the findings of earlier studies and offers additional preliminary evidence that polymer- based, paclitaxel-eluting stents appear to be a safe treatment for coronary artery disease," said Dr. Stephen Ellis, the trial's Co-Principal Investigator. "I look forward to the presentation of the long-term safety and efficacy data next summer."

The Company also announced 12-month clinical follow-up data from its TAXUS I trial. The 61-patient trial is assessing the safety of the slow-release formulation. It reported zero thrombosis and zero restenosis at six months. At 12 months, intervention rates remained extremely low, with only one Target Vessel Revascularization reported in the paclitaxel-eluting stent group, compared to four events (three Target Lesion Revascularizations and one Coronary Artery Bypass Graft) reported in the bare stent control group.

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.


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

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