First Patient Enrolled in Boston Scientific Randomized Study of
Removable WallFlex® Biliary RX Fully Covered Stent for Patients
Suffering From Chronic Pancreatitis
NATICK, Mass., Dec. 4, 2012 /PRNewswire/ -- The first
patient has been enrolled in a Boston Scientific Corporation (NYSE:
BSX) study comparing the WallFlex® Biliary RX Fully Covered
self-expanding metal stent (SEMS) to plastic stents for the
treatment of benign bile duct strictures caused by chronic
pancreatitis. This multi-center, prospective, randomized
study will enroll 164 patients at leading hospitals in Australia, Austria, Belgium, Canada, France, Germany, Hong
Kong, India, Italy and the
Netherlands.
In a separate single-arm study, 187 patients were treated with
the WallFlex Stent for multiple types of benign biliary strictures
including, those caused by chronic pancreatitis. The stents
implanted in that study were removed up to one year after being
placed in the body. Five-year follow-up post stent removal is
ongoing. Preliminary data were presented this summer at Digestive
Disease Week 2012 by Professor Jacques
Deviere of Erasme Hospital in Brussels. The data
indicate that a SEMS can be removed safely any time up to one year
post placement, and that short-term stricture resolution rates
compare favorably with the results reported with plastic stents in
chronic pancreatitis-related benign biliary strictures.
"Preliminary data show promising results for the treatment of
chronic pancreatitis-related benign biliary strictures using SEMS,
compared to literature on the use of plastic stenting," said
Professor Puspok of the Medical University of Vienna, an investigator in both studies who
enrolled the first patient in the randomized study. "Multiple
plastic stenting remains an established treatment choice for
biliary strictures caused by chronic pancreatitis. However,
this form of treatment requires multiple stent exchanges and the
long-term success rate is low. Treatment with removable fully
covered SEMS could overcome these limitations. A head-to-head
comparison of both stenting treatment regimens is essential in
order to collect robust data to guide physicians in the optimal
treatment of their patients with chronic pancreatitis."
SEMS, which have a significantly larger diameter than plastic
biliary stents, have long been the standard of care for palliation
of malignant biliary strictures. The studies above are
evaluating the benefits of using a SEMS in benign biliary
strictures, with an objective to demonstrate stricture resolution
in fewer procedures.
"Boston Scientific continues to deliver industry-leading
technologies that enhance patient quality of life," said
David Pierce president of the
Endoscopy business at Boston Scientific. "We are hopeful that the
results of this study will demonstrate clinical benefit and cost
effectiveness of a single metal stent approach versus plastic
stenting, which typically requires multiple procedures."
The WallFlex Biliary RX Fully Covered Stent has a silicone
polymer Permalume® Coating designed to reduce the potential for
tumor/tissue ingrowth, and an integrated retrieval loop for
removing or repositioning the stent in the event of incorrect
placement during the initial procedure or for removal from benign
strictures up to one year after placement. The stent is
constructed of braided, platinum-cored Nitinol wire (Platinol™
Wire) and features three key components: 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 complete line of WallFlex Stents − Fully Covered, Partially
Covered and Uncovered − is available in the United States and has CE Mark approval for
use in the palliative treatment of malignant biliary
strictures. In addition, the WallFlex Biliary RX Fully
Covered stent is CE marked for the treatment of benign biliary
strictures. The WallFlex Stent is the most frequently
implanted biliary metal stent worldwide.
The WallFlex Stent is not approved in the United States for use in the treatment of
benign biliary strictures. The safety and effectiveness of
the stent for use in the vascular system have not been
established.
For more information, visit Boston Scientific Endoscopy
Resources on-line at
www.bostonscientific.com/endo-resources.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and
marketer of medical devices that are used in a broad range of
interventional medical specialties. For more information,
please visit: www.bostonscientific.com.
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Media Relations
Boston Scientific Corporation
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SOURCE Boston Scientific Corporation