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September 25, 2008 -- When it comes to coronary artery blockages, the narrower the artery, the greater the chance that it will restenose (re-close) after placement of a stent. Drug-eluting stents (DES) are known to reduce restenosis, but the smallest diameter DES available in the United States has been a 2.5mm, stent; that is until today, when the U.S. Food and Drug Administration gave Boston Scientific Corporation (NYSE: BSX) approval to market its TAXUS® Express2™ Atom™ Paclitaxel-Eluting Coronary Stent System for vessels as small as 2.25 mm in diameter. The Company plans to launch the product immediately.
Boston Scientific also enjoyed a second FDA approval: an expanded indication for its standard-sized TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System, now okayed for the treatment of in-stent restenosis in bare-metal stents. This is the first such approval granted by the FDA, making the TAXUS Express2 Stent System the only drug-eluting stent approved in the United States for the treatment of in-stent restenosis in bare-metal stents. In the announcement, Boston Scientific CEO and President, Jim Tobin, stated, "With the recent FDA approval of our PROMUS™ Stent and now the TAXUS Express Atom Stent for small vessels, Boston Scientific offers the most comprehensive DES portfolio in the industry, offering physicians and their patients the broadest size matrix and the industry's only two-drug platform." Indeed, as evidenced by these approvals, the Company, which has been operating under a warning letter from the FDA since January 2006 preventing it from introducing completely new devices, may be on the way to better relations with the FDA. An article in today's Wall Street Journal ("New Boston Sci Stent Signals Progress On FDA Warning Letter") quotes stock analyst Phil Nalbone as saying, "It's not the product per se. It's the implicit message that BSX must be working and playing well with the FDA."
Reported by Burt Cohen, September 25, 2008 |
