Stuttgart (ots) - Mit den neuen Zweisitzern 718 Boxster GTS und 718 Cayman GTS baut Porsche seine ...
Boston Scientific CRE? Wireguided Balloon Dilator CE Marked for Expanded Indication
Paris, November 9 (ots/PRNewswire) - Now available for endoscopic dilation of the Sphincter of Oddi following sphincterotomy
Boston Scientific Corporation's CRE(TM) Wireguided Balloon Dilator is now CE marked for endoscopic dilation of the Sphincter of Oddi following sphincterotomy. The new indication, which supplements the product's current indication for use in the alimentary (digestive) tract, lets physicians perform Dilation Assisted Stone Extraction (DASE), providing an alternative method to remove difficult stones in the biliary duct.
"DASE is a valuable technique to facilitate extraction of difficult-to-manage gallstones," said Prof. Marco Bruno, M.D., Professor of Gastrointestinal Oncology, Director of Gastroenterology & Endoscopy, Erasmus Medical Center, Rotterdam. "This procedure should be considered as an option to treat large common bile duct stones, especially when conventional stone extraction fails or in challenging cases with anatomical variants. When used appropriately, it has the potential to reduce the number of cumbersome and costly re-interventions."
Constructed of Pebax(R) material, the CRE Wireguided Balloon Dilator is designed to deliver three distinct, pressure-controlled diameters in a single balloon, allowing gradual dilation of strictures. The balloon's rounded-shoulder design is engineered to help facilitate endoscopic visualization or Balloon Endoscopy and provide greater usable balloon surface area during dilation.
"In our institution, DASE has become a routine intervention used to manage difficult bile stones," said Prof. Horst Neuhaus, M.D., Professor of Medicine, Head of the Department of Internal Medicine, Evangelisches Krankenhaus Duesseldorf. "Our clinical experience is consistent with study findings that DASE is safe, effective and easy to employ. It reduces the need for mechanical lithotripsy and simplifies removal of larger stones or stone fragments."
"The new indication provides physicians an alternative method for treating patients requiring difficult stone extraction in the biliary duct, and demonstrates Boston Scientific's ongoing commitment to innovation and clinical science to expand endoscopic therapies available to physicians and patients," said David Pierce, President of Boston Scientific's Endoscopy Division. "The CRE Balloon has been a key offering in our Endoscopy product portfolio for more than 14 years and has helped solidify our market leadership."
The presence of stones in the common bile duct affects more than 61 million people worldwide, resulting in 800,000 therapeutic ERCP procedures each year. If not treated, the condition can cause biliary obstruction, infection, jaundice and liver damage.
In the U.S., the CRE Wireguided Balloon is not cleared for dilation of the Sphincter of Oddi following sphincterotomy.
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.
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 indications, regulatory approvals, business plans, clinical trials and product performance. 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.
Simonetta Balbi, PR and Corporate Communication Manager,