NATICK, Mass., Sept. 14 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today issued the following comment on the statement of the U.S. Food and Drug Administration on drug-eluting stents:
"Boston Scientific welcomes the FDA's statement that it believes drug- eluting stents remain safe and effective when used for the FDA-approved indications.
"A large body of clinical evidence -- including randomized, controlled trials in nearly 3,500 patients -- demonstrates that the TAXUS drug-eluting stent substantially reduces the risk of restenosis and repeat intervention compared to bare-metal stents, with no corresponding increase in death, cardiac death and heart attack. The existing data continues to provide reassurance to physicians and patients that the TAXUS drug-eluting stent is as safe and more effective than bare-metal stents.
"Boston Scientific is currently conducting additional clinical studies involving more than 10,000 patients with long-term follow up to evaluate the TAXUS stent in an even broader range of patients and lesions.
"We look forward to continuing to work closely with the FDA and to continuing to share our data with them."
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: http://www.bostonscientific.com/.
This press release contains forward-looking statements. Boston Scientific 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 new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, integration of acquired companies, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
CONTACT: Milan Kofol 508-650-8569 Investor Relations Boston Scientific Corporation Paul Donovan 508-650-8541 Media Relations Boston Scientific Corporation
SOURCE: Boston Scientific Corporation
CONTACT: Milan Kofol, Investor Relations, +1-508-650-8569, or Paul
Donovan, Media Relations, +1-508-650-8541, both of Boston Scientific
Web site: http://www.bostonscientific.com/