Boston Scientific Announces Enrollment of First Patient in Benign Stricture Study of WallFlex(R) Biliary RX Stent.NATICK, Massachusetts and DUSSELDORF, Germany, January 15 /PRNewswire/ -- Boston Scientific Corporation (NYSE NYSE
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BSX Bicycle Super-X (Cross) ) today announced that the first patient has been enrolled in a clinical trial to evaluate its WallFlex(R) Biliary RX Fully Covered Stent for the treatment of benign bile duct strictures. This multi-center, prospective study plans to enroll 187 patients at 11 centers(1) worldwide over the next 18 months. The first patient was enrolled by Professor Horst Neuhaus at the Evangelisches Krankenhaus in Dusseldorf, Germany. Lead Investigators in the study are Professor Jacques Deviere of Hospital Erasme in Brussels, and Professor Guido Costamagna of Policlinico A. Gemelli in Rome.
"We are pleased to have enrolled the first patient in this important trial to assess the WallFlex Biliary RX Fully Covered Stent as a potential option for the treatment of benign biliary strictures," said Professor Neuhaus. "The WallFlex Stent has proved to be effective in the management of malignant bile duct strictures, and the start of this trial represents a significant clinical milestone in determining optimal treatment strategies for patients with benign bile duct strictures."
The trial will evaluate the removal of the stents from patients with benign bile duct strictures as well as the effectiveness of temporary stenting for long-term, benign biliary stricture resolution. The study will include patients with bile duct strictures associated with post liver transplant anastomosis anastomosis /anas·to·mo·sis/ (ah-nas?tah-mo´sis) pl. anastomo´ses [Gr.]
1. communication between vessels by collateral channels.
2. , prior abdominal surgery such as cholecystectomy Cholecystectomy Definition
A cholecystectomy is the surgical removal of the gallbladder. The two basic types of this procedure are open cholecystectomy and the laparoscopic approach. (gall bladder gall bladder, small pear-shaped sac that stores and concentrates bile. It is connected to the liver (which produces the bile) by the hepatic duct. When food containing fat reaches the small intestine, the hormone cholecystokinin is produced by cells in the intestinal removal) and chronic pancreatitis (inflammation of the pancreas). The WallFlex Biliary RX Stent will remain in the patients four to 12 months depending on the nature of the stricture. Patients will be followed for five years after stent removal.
"We believe this trial is the most comprehensive of its kind and is critical to advancing our knowledge of fully covered, self-expanding metal stenting as an endoscopic treatment for benign biliary strictures," said Professor Deviere. "Use of the WallFlex Biliary RX Fully Covered Stents in these patients may provide significant benefits as a minimally invasive alternative to surgery."
The WallFlex Biliary RX Stent is constructed of braided, platinum-cored Nitinol wire (Platinol(TM) Wire) and features three key components: radial force to help maintain duct patency pa·ten·cy
The state or quality of being open, expanded, or unblocked.
the condition of being open. and resist migration, flexibility to aid in conforming to tortuous anatomies and full-length radiopacity radiopacity /ra·di·opac·i·ty/ (-pas´i-te) the quality or property of obstructing the passage of radiant energy, such as x-rays, the representative areas appearing light or white on the exposed film. to enhance stent visibility under fluoroscopy fluoroscopy /flu·o·ros·co·py/ (fldbobr-ros´kah-pe) examination by means of the fluoroscope.
Examination by means of a fluoroscope. Also called radioscopy. . The WallFlex Biliary RX family of stents is available in fully covered, partially covered and uncovered versions. The covered stents have a silicone polymer coating designed to reduce the potential for tumor ingrowth ingrowth /in·growth/ (-groth) an inward growth; something that grows inward or into.
Something that grows inward or into a part of the body. , and an integrated retrieval loop for removing or repositioning the stent during the initial procedure in the event of incorrect placement.
"The start of patient enrollment in the WallFlex study is an important achievement for Boston Scientific, and we look forward to continuing enrollment in additional countries in the near future," said Michael Phalen, President, Boston Scientific Endoscopy. "The WallFlex Biliary RX Stent System was designed with physician feedback in mind, reinforcing our commitment to providing physicians with the world's leading technologies to treat and diagnose digestive diseases."
The WallFlex Biliary RX Stents have received U.S. Food and Drug Administration clearance and CE Mark approval and are indicated for the palliative treatment of biliary strictures produced by malignant neoplasms. 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: 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. Boston Scientific wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, Boston Scientific's overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
(1) Centers are in: Australia, Austria, Belgium, Canada, France, Germany, India, Italy, the Netherlands and Spain.
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