Boston Scientific Announces FDA Clearance and U.S. and European Availability of WallFlex(R) Biliary RX Covered Stents
06 Octubre 2009 - 7:36AM
PR Newswire (US)
Three models of stenting system now available for palliative
treatment of malignant common bile duct strictures NATICK, Mass.,
Oct. 6 /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) to market its
WallFlex® Biliary RX fully and partially covered stents for the
palliative treatment of malignant bile duct strictures. The
WallFlex Biliary RX uncovered stent was cleared by the FDA in 2006.
All three models of the WallFlex Biliary RX Stenting System --
fully covered, partially covered and uncovered -- are now available
in both the United States and Europe. "The WallFlex Biliary RX
Stent System represents the next stage in self-expandable metal
stent technology. The stent has greater flexibility to aid with
placement in tortuous anatomies and new features such as flared
ends that may reduce the risk of migration," said Kenneth F.
Binmoeller, M.D., Director of Interventional Endoscopy at
California Pacific Medical Center, and an investigator for the
WallFlex Biliary RX fully covered stent study. The WallFlex Biliary
RX Stent is designed to offer the benefits of prior-generation
stents, such as the industry-leading WALLSTENT® Endoprosthesis,
while incorporating new features to accommodate a range of
anatomical and clinical requirements. Based on extensive research
and physician feedback, the WallFlex Biliary RX Stent employs a
platinum-cored Nitinol construction designed to deliver on three
critical components: radial force, flexibility and radiopacity. The
Platinol(TM) Wire provides greater flexibility - 30 percent more
than the WALLSTENT Endoprosthesis - to help the stent conform
within tortuous anatomies. The enhanced full-length radiopacity
offered by the Platinol Wire and the reconstrainable delivery
system are designed to allow for more precise stent placement,
while the radial force of the WallFlex Biliary RX Stent is designed
to maintain patency and resist migration(1, 2). TheWallFlex Biliary
RX Stents also feature a closed-cell construction designed to
resist tissue ingrowth(2), looped ends intended to reduce the risk
of tissue trauma, and flared ends to help reduce the risk of stent
migration. The proprietary, durable silastic polymer (Permalume®)
covering of the fully and partially covered stents is designed to
reduce the potential for tumor ingrowth. In addition, the WallFlex
Biliary RX Stent incorporates an integrated retrieval loop for
removal during the initial stent placement procedure, which can be
used in the event of incorrect placement. "Boston Scientific
continues to fulfill our promise to deliver industry-leading,
innovative technologies that enable physicians to best diagnose and
treat digestive diseases, and enhance quality of life for
patients," said Michael Phalen, President, Boston Scientific
Endoscopy. "The WallFlex Biliary RX Stent leverages existing Boston
Scientific technologies, while advancing performance with new
features such as a unique Platinol Wire construction. We believe we
are truly delivering the next generation of stents for the
treatment of malignant bile duct strictures." Preliminary results
from Dr. Petersen's study were reported at United European
Gastroenterology Week (UEGW) in 2008. Results showed that the fully
covered WallFlex Biliary RX Stent yielded technically successful
placement, low rates of re-intervention (two percent) and recurrent
biliary obstruction, and minimal occurrence of migration (two
percent) and complications. With 98 percent of patients meeting the
primary endpoint of clinical palliation of the biliary obstruction
until completion of follow-up, study results suggest that the fully
covered WallFlex Biliary RX Stent may successfully palliate most
patients with malignant distal biliary obstructions. Also presented
at UEGW were preliminary data on a 70-patient WallFlex Biliary RX
partially covered stent study led by Primary Investigator Guido
Costamagna, M.D., Head of Digestive Endoscopy at Universita
Cattolica del Sacro Cuore in Rome. Preliminary results of the study
demonstrate that the partially covered metal stent may palliate
most patients with malignant biliary obstructions. Pancreatic
cancer is the most common cause of malignant biliary obstructions
with 250,000 new cases diagnosed worldwide each year. Most patients
have less than six months to live after diagnosis(3). Other causes
of malignant biliary obstructions include bile duct, liver and
gallbladder cancer. Approximately 70 percent of patients with a
malignant bile duct obstruction are poor candidates for surgery
because the cancer has spread (4). With these cases, palliative
treatment can improve the patient's quality of life by controlling
the symptoms and complications of the disease. The safety and
effectiveness of the WallFlex Biliary RX Stenting System for use in
the vascular system have not been established. 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
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These forward-looking statements include, among other things our
product performance, regulatory approval of our products,
competitive offerings, our growth strategy, and our market
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or if certain risks or uncertainties materialize, actual results
could vary materially from the expectations and projections
expressed or implied by our forward-looking statements. These
factors, in some cases, have affected and in the future (together
with other factors) could affect our ability to implement our
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from those contemplated by the statements expressed in this press
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other important risks and uncertainties that may affect our future
operations, see Part I, Item 1A - Risk Factors in our most recent
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in Quarterly Reports on Form 10-Q we have filed or will file
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update or revise any forward-looking statements to reflect any
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circumstances on which those expectations may be based, or that may
affect the likelihood that actual results will differ from those
contained in the forward-looking statements. This cautionary
statement is applicable to all forward-looking statements contained
in this document. (1) Soderlund K., Linder S.; Covered metal versus
plastic stents for malignant common bile duct stenosis: a
prospective, randomized, controlled trial. Gastrointestinal
Endoscopy, June 2006; 63: 986-995. (2) Moss A.; Morris E.;
MacMathuna P.; Palliative biliary stents for obstructing pancreatic
carcinoma. Cochrane Database Systematic Review, January 25, 2006.
(3) Association for International Cancer Research,
http://www.aicr.org.uk/PancreaticCancerFAQs.stm, August 17, 2009.
(4) Mahesh Kumar Neelala Anand, Pancreas,
Adenocarcinoma.emedicine.com. 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 Corporation DATASOURCE: Boston Scientific
Corporation CONTACT: Paul Donovan, Media Relations, +1-508-650-8541
(office), or +1-508-667-5165 (mobile); or Larry Neumann, Investor
Relations, +1-508-650-8696 (office), both of Boston Scientific
Corporation Web Site: http://www.bostonscientific.com/
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