Healthcare Industry News:  biliary stricture 

Devices Gastroenterology Interventional

 News Release - March 22, 2012

Boston Scientific Begins U.S. and International Launch of WallFlex(R) Biliary Transhepatic Stent System

Company's WallFlex Biliary Stents now available with a Transhepatic delivery system for use by interventional radiologists in treating obstructions within the biliary tract

NATICK, Mass., March 22, 2012 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (NYSE: BSX ) announces the U.S. and international launch of the WallFlex® Biliary Transhepatic Stent System. This third-generation stent platform is now available with a percutaneous delivery system designed for use by interventional radiologists in the palliative treatment of biliary strictures produced by malignant tumors. The WallFlex Biliary Transhepatic Fully Covered Stent System is also available for the treatment of benign biliary strictures in CE marked countries.

"We are very excited that the WallFlex Stent technology, originally designed for gastroenterologists, is now available for interventional radiologists and the patients we typically treat through percutaneous procedures," said Kelvin Hong, M.D., Johns Hopkins University, Baltimore, Maryland. "The WallFlex Biliary Transhepatic Stent System offers the latest advances in self-expanding metal stent technology with a delivery system designed specifically for the interventional treatment of malignant biliary strictures."

The WallFlex Biliary Transhepatic Stent is available in fully covered, partially covered and uncovered versions in multiple sizes to accommodate different anatomical and clinical requirements. The covered stents have a silicone polymer Permalume® coating designed to reduce the potential for tumor/tissue ingrowth, and an integrated retrieval loop for endoscopic removal or repositioning during the initial procedure in patients that may have an ERCP[1] performed.

"By providing interventional radiologists with a third-generation stent platform supported by strong clinical evidence and innovative features, Boston Scientific continues to deliver industry-leading technologies that enhance patient quality of life," said David Pierce, President of the Endoscopy Division at Boston Scientific. "The launch of the WallFlex Biliary Transhepatic Stent System extends the ability of this technology to treat more patients with biliary strictures."

The WallFlex Biliary RX Stents and the WallFlex Biliary Transhepatic Stents are CE-Marked and have received FDA clearance for the palliative treatment of malignant biliary strictures. Additionally, the WallFlex Biliary RX Fully Covered Stent and the WallFlex Biliary Transhepatic Fully Covered Stent System are CE-Marked for the treatment of benign biliary strictures.

For more information on the WallFlex System, visit the Boston Scientific Endoscopy Channel at

The safety and effectiveness of the WallFlex Biliary RX Stent System and the WallFlex Biliary Transhepatic Stent 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 that are used in a broad range of interventional medical specialties. For more information, please visit:

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "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, statements regarding new product launches, product performance, clinical outcomes, our business plans and competitive offerings. If our underlying assumptions turn out to be incorrect, 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 business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.

Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or 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] Endoscopic Retrograde Cholangiopancreatography

Source: Boston Scientific

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