Boston Scientific Announces FDA Clearance and CE Mark for WallFlex(R) Fully Covered Esophageal Stent
20 Noviembre 2009 - 8:41AM
PR Newswire (US)
Complete portfolio of Company's WallFlex Stent family of
self-expanding metal stents now available in U.S., Europe and other
international markets NATICK, Mass. and LONDON, Nov. 20
/PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE:BSX)
today announced that it has received 510(k) clearance from the U.S.
Food and Drug Administration (FDA) and CE Mark approval to market
its WallFlex® Fully Covered Esophageal Stent for the treatment of
malignant esophageal strictures (obstructions) caused by tumors in
patients with resectable or non-resectable esophageal cancer.
(Photo: http://www.newscom.com/cgi-bin/prnh/20091120/NE13563 ) The
WallFlex® Partially Covered Esophageal Stent was cleared by the FDA
and received CE Mark in 2008. Both stents -- along with the
complete WallFlex Stent family of self-expanding metal stents
(SEMS) -- will be available for hands-on demonstration at the
GASTRO 2009 conference, which is being held November 21-25 in
London. "The low profile delivery system (18.5 Fr) of the WallFlex
Esophageal Stents has allowed me to traverse tight strictures,
facilitating stent placement within malignancies that, in the past,
needed to be pre-dilated," said Drew Schembre, M.D., Chief of
Gastroenterology at Virginia Mason Medical Center in Seattle,
Washington. "Moreover, the fully covered option may be a viable
choice for patients with operable esophageal cancer who are
undergoing chemotherapy and radiation treatment in preparation for
surgery." Patients with obstructions due to esophageal cancer may
have difficulty swallowing, resulting in severely limited quality
of life. Complete blockages of the esophagus can prevent liquid
consumption. The WallFlex Esophageal Stent allows physicians to
re-establish patency (openness) of the esophagus, enabling
resumption of oral intake. The WallFlex Fully and Partially Covered
Stents employ a proprietary Permalume® silicone covering designed
to prevent tumor ingrowth, seal concurrent esophageal fistulas and
help reduce food impaction. The stents' progressive-step, flared
ends are designed to reduce the risk of migration and may assist in
anchoring the fully covered stent within the esophageal lumen. The
multiple wire-braided construction is engineered to allow the stent
to adjust to forces within the esophagus such as peristalsis
(involuntary contractions) and strictures. In addition, the
WallFlex Fully Covered Stent may be reconstrained up to 75 percent
deployment. "The availability of the complete line of WallFlex
Fully and Partially Covered Esophageal Stents represents a
tremendous milestone for Boston Scientific," said Michael Phalen,
President, Boston Scientific Endoscopy. "This advanced line of
esophageal stents is designed to improve the quality of life for
the thousands of patients suffering from esophageal cancer. We are
pleased that our entire WallFlex Stent family -- biliary, enteral
and now esophageal -- is available in the U.S., Europe and other
strategic international markets. This underscores our mission to
meet the high expectations of our customers and deliver a complete
range of innovative treatment options to diagnose, palliate and
treat patients with diseases of the gastrointestinal tract."
Symposium at GASTRO 2009 Boston Scientific will host a symposium
titled "Esophageal Stenting: Changing Algorithms, Changing
Outcomes" on Tuesday, November 24 at 7:00 a.m. at GASTRO 2009 in
London. The event will be moderated by Professor Horst Neuhaus of
Evangelisches Krankenhaus in Dusseldorf, Germany. Panelists and
topics include Dr. Marc Giovannini, Institut Paoli-Calmettes in
Marseille, France, who will discuss advancing treatment options;
Professor Jacques Deviere, Erasme Hospital in Brussels, Belgium,
who will address benign conditions and expanding the role of
stents; and Professor Peter Siersema, University Medical Center
Utrecht in The Netherlands who will discuss minimizing
reintervention rates in stenting. About Boston Scientific 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: http://www.bostonscientific.com/. About Boston Scientific
Endoscopy Boston Scientific Endoscopy develops innovative
technology for less invasive, more efficient gastrointestinal
procedures. Cautionary Statement Regarding Forward-Looking
Statements This press release contains forward-looking statements
within the meaning of Section 21E of the Securities Exchange Act of
1934. Forward-looking statements may be identified by words like
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"intend" and similar words. These forward-looking statements are
based on our beliefs, assumptions and estimates using information
available to us at the time and are not intended to be guarantees
of future events or performance. These forward-looking statements
include, among other things, our product performance, regulatory
approval of our products, competitive offerings, our growth
strategy, and our market position. If our underlying assumptions
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forward-looking statements. These factors, in some cases, have
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CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile)
Media Relations Boston Scientific Corporation Larry Neumann
508-650-8696 (office) Investor Relations Boston Scientific
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Corporation CONTACT: Paul Donovan, +1-508-650-8541 (office),
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+1-508-650-8696 (office), Investor Relations, both of Boston
Scientific Corporation Web Site: http://www.bostonscientific.com/
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