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Boston Scientific Announces CE Mark Approval for Expanded Indication of WallFlex® Biliary RX Stent

October 22, 2010 By Bio-Medicine.Org

NATICK, Mass., Oct. 22 /PRNewswire/ — Boston Scientific
Corporation (NYSE:
BSX
) today announced that its WallFlex® Biliary RX Fully
Covered Stent has received CE Mark approval for the treatment of
benign biliary strictures.  

“The WallFlex Biliary RX Fully Covered Stent has proved
effective in the management of malignant biliary strictures, and
I’m pleased that physicians in Europe and other CE Mark countries
can now use this stent to treat benign biliary strictures,” said
Professor Jacques Deviere, M.D., Ph.D., Hopital Erasme in Brussels.
 “The WallFlex Stent incorporates the latest innovations in
self-expanding metal stent technology and may provide significant
benefits as a less-invasive alternative to surgery in these
patients.”

“This new indication gives me the confidence to perform what I
have found to be the most effective therapy – metal stent
placement – during the initial ERCP(1) procedure in patients
where previously I would have waited for a confirmed diagnosis of
the stricture,” said Adrian Hatfield, M.D., University College
London Hospital.  “It may help to reduce the number of
procedures my patients must undergo, while containing costs and
providing the best possible care.”

The WallFlex Biliary RX Stent is constructed of braided,
Platinol™ (platinum-cored Nitinol) wire and features three
key attributes: radial force to help maintain duct patency and
resist migration, flexibility to aid in conforming to tortuous
anatomies, and full-length radiopacity to enhance stent visibility
under fluoroscopy.  The WallFlex Biliary RX family of stents
is available in fully covered, partially covered and uncovered
versions.  The covered stents have a silicone polymer
Permalume® coating designed to reduce the potential for
tumor/tissue ingrowth, and an integrated retrieval loop for
removing or repositioning the

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SOURCE

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