Healthcare Industry News: drug-eluting stent
News Release - April 17, 2008
Boston Scientific Receives Canadian Approval for TAXUS(R) Liberte(R) Stent SystemCompany plans to launch product immediately
NATICK, Mass., April 17 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced that it has received approval for the sale of its TAXUS® Liberte® paclitaxel-eluting coronary stent system in Canada. The Company reported that Health Canada's Therapeutic Products Directorate (TPD), the authority that regulates pharmaceutical drugs and medical devices, has approved its use. The Company said it plans to launch the product immediately in Canada.
"The TAXUS Liberte Stent is a major advance in stent development and raises the bar for drug-eluting stent systems," said Serge Doucet, M.D., Cathlab Director at the Montreal Heart Institute. "It offers enhanced ability to conform to the vessel wall and deliver across some of the most challenging lesions. This innovation is welcome news for interventional cardiologists and patients in Canada who suffer from coronary artery disease."
"This stent is designed specifically for improved drug elution and deliverability," said David McFaul, Boston Scientific Senior Vice President, International. "Coupled with our proven paclitaxel-eluting technology, TAXUS Liberte provides physicians with next-generation performance. We are delighted that Canadian physicians and patients can now benefit from this highly advanced technology for the treatment of coronary artery disease."
Currently the leading drug-eluting stents worldwide, TAXUS Stent Systems have been evaluated by the industry's most extensive randomized, controlled clinical trial program, as well as studied in more than 35,000 real-world patients enrolled in post-approval registries. To date, approximately four million TAXUS Stents have been implanted worldwide.
The TAXUS Liberte Stent has previously been approved for sale in Europe and other international markets and is currently awaiting approval by the U.S. Food and Drug Administration and is not available for sale in the United States.
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.
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 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 our product performance, regulatory approval of our products, new product launches, competitive offerings, our growth strategy, and our market position. 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 thereafter. 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.
Source: Boston Scientific
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