FDA Approves Boston Scientific's Carotid Artery Stent

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Thu Oct 23, 2008 5:09pm EDT

Leading carotid stent in Europe and other international markets now available
in the United States

NATICK, Mass., Oct. 23 /PRNewswire-FirstCall/ -- Boston Scientific Corporation
(NYSE: BSX) today announced that the U.S. Food and Drug Administration (FDA)
has approved its Carotid WALLSTENT(R) Monorail(R) Endoprosthesis for the
treatment of patients with carotid artery disease who are at high risk for
surgery.  The Carotid WALLSTENT Endoprosthesis is the leading carotid stent in
Europe and other international markets.  The Company said it plans to launch
the product immediately in the United States.
"We are pleased to bring this proven technology to physicians in the United
States," said Hank Kucheman, Senior Vice President and Group President of
Boston Scientific's Cardiovascular business.  "Excellent patient outcomes and
ease of use in complex anatomy have already made this system the number-one
stenting option for treating carotid artery disease in Europe and other
countries outside the U.S.  It offers a less-invasive alternative to surgery
for treating carotid artery disease, and can help reduce the risk of stroke,
which can have devastating effects."
The Carotid WALLSTENT is a self-expanding stent mounted on a rapid exchange
delivery system, designed to re-open the carotid artery by treating stenoses,
and improve blood flow to the brain.  The stent features a closed-cell design,
engineered for excellent lesion coverage and angiographic results.  The system
is designed to be highly deliverable and provide access to the toughest
lesions.  
It is used in conjunction with the FilterWire EZ(TM) Embolic Protection
System, which is designed to capture plaque debris released during the
stenting procedure, preventing it from traveling to the brain, where it could
create an increased risk for stroke.  The device features simplified filter
sizing - accommodating vessel diameters between 3.5 mm and 5.5 mm - and offers
efficient preparation, deployment and retrieval.
"The closed-cell design of the Carotid WALLSTENT Endoprosthesis is intended to
provide increased scaffolding for optimal lesion coverage and a smooth inner
lumen," said Barry T. Katzen, M.D., Medical Director, Baptist Cardiac and
Vascular Institute, Miami.  "This feature will make the Carotid WALLSTENT an
attractive new treatment option for U.S. physicians and their patients."
The Carotid WALLSTENT Endoprosthesis with the FilterWire EZ System is the only
carotid artery stent system approved in the United States with an indication
that includes the treatment of bilateral carotid artery disease (blockages in
the carotid arteries on both sides of the neck).
The carotid arteries are the main conduits through which blood flows from the
heart to the brain.  Carotid artery disease occurs when fatty plaque builds up
inside the vessels, causing them to harden and narrow, which increases the
risk of stroke.  Most patients with carotid artery disease are treated with
carotid endarterectomy, a surgical procedure involving an incision in the neck
and removal of the plaque from the vessel walls.  Carotid artery stenting is a
less-invasive alternative in which a stent is delivered to the site of the
blockage and expanded, forcing open the walls of the arteries and restoring
blood flow.    
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:
www.bostonscientific.com.   

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SOURCE  Boston Scientific Corporation

Paul Donovan, +1-508-650-8541 (office), +1-508-667-5165 (mobile), Media
Relations, or Larry Neumann, +1-508-650-8696 (office), Investor Relations,
both of Boston Scientific Corporation
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