Healthcare Industry News: drug-eluting stent
News Release - May 16, 2006
TAXUS(R) Liberte(TM) Stent System Receives European Approval for Three Complex Coronary ProceduresBoston Scientific's second-generation stent system now approved for treatment of acute mycocardial infarction, total occlusions and in-stent restenosis
Large vessel TAXUS Liberte stent also receives CE mark
NATICK, Mass., May 16 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) announced today that it has received indication extensions to the European CE mark for its TAXUS® Liberte(TM) paclitaxel-eluting coronary stent system for use in some of the most challenging coronary procedures.
The new labeling reflects a review of TAXUS clinical data by the European regulatory agency. In addition to its existing indication for the treatment of de-novo lesions in native coronary arteries, the TAXUS Liberte stent system is now indicated in Europe for the treatment of restenotic lesions (in-stent restenosis, or ISR) and total occlusions (TO) in patients with coronary artery disease, including acute myocardial infarction (AMI). These three new indications account for more than 20 percent of all coronary interventions.
The TAXUS Liberte stent system is now the only drug-eluting stent system with these new indications for use in Europe.
This revised labeling follows the excellent clinical outcomes the TAXUS stent system has shown in the treatment of complex lesions in recent clinical trials and registries, including the TAXUS V ISR trial and the MILESTONE II, WISDOM, ARRIVE, and OLYMPIA registries.
In addition to the three new indications, the large vessel diameter TAXUS Liberte stent also received the CE mark. This stent uses a modified cell design intended for drug delivery in larger vessels, and will be available in a 4.0 mm diameter and seven different lengths.
"The European approval for new indications recognizes the strong long-term performance of the TAXUS stent system across complex patients and lesions," said Jeff Goodman, President of Boston Scientific International. "It allows physicians to treat difficult cases of coronary artery disease with the most advanced technology."
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, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
Source: Boston Scientific
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