Safeplus International Holdings Ltd. (ACAI)

[krays]

Well Bubba since you showed me the website I guess now I should use it. Heres some additional info related to your response. Thanks for the comments btw.


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FDA Lifts Part of Boston Scientific's
Warning Letter Restrictions

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related stories:
Drug-Eluting Stent Center

Boston Scientific Announces FDA Approval of Second-Generation TAXUS® Liberte® Drug-Eluting Stent


October 22, 2008 -- Boston Scientific announced today that the U.S. Food and Drug Administration has lifted part of the warning letter that the company has been laboring under for almost three years.

On January 25, 2006, just hours after the massive acquistion agreement between Boston Scientific, Guidant and Abbott was signed, the FDA faxed a stern company-wide admonition that, among a number of other cautions, took Boston Scientific to task for late or non-reporting of 145 adverse incidents involving a range of devices. The FDA was upset because previous warnings had gone unresolved and the letter stated that future Class III approvals would be on hold until the issues were dealt with.

Indeed the company has received no major device approvals in the past 32 months, until two weeks ago, when the FDA approved Boston's Taxus® Liberte® drug-eluting stent, an application that had been pending since the warning letter was issued. The Liberte, a stent similar to the company's flagship Taxus® Express®, but with thinner struts, rendering it more "deliverable", has been sold in Europe since 2005.

Analysts do not predict that the Liberte will make a significant difference in Boston Scientific's U.S. market share, mainly because the three-year-old technology has already been out-distanced by the newer Endeavor and XIENCE stents from competitors Medtronic and Abbott. Abbott, in fact, has Boston Scientific in its sights -- Abbott's newest ad campaign aimed at interventional cardiologists, was launched this week, and says of the Liberte: "New Name, Same Story".

However, the lifting of these warning letter restrictions is certainly a long-awaited positive step for the company's future and its relationship with the FDA. Boston Scientific manufactures a number of devices that allow minimally invasive treatment for many parts of the body, from carotid stents to coils that can treat strokes and aneuryms. Besides its significant heart rhythm division (pacemakers and ICDs) acquired from Guidant, the company also markets the XIENCE drug-eluting coronary stent under its own brand-name PROMUS™, as part of a profit-sharing agreement with Abbott.

http://www.ptca.org/news/2008/102203_BSX.html