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FDA Lifts Part of Boston
Scientific's
Warning Letter Restrictions
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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.
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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.
Reported by Burt Cohen, October 22, 2008
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