Boston Scientific Announces Japanese Approval For TAXUS(R) Liberte(R) Drug-Eluting Stent System

January 29, 2009 at 8:00 am Leave a comment


Boston Scientific Corporation (NYSE: BSX) announced that it has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to market its TAXUS(R) Liberte(R) Paclitaxel-Eluting Coronary Stent System. The Company plans to launch the product as soon as reimbursement approval is granted, which is expected in the coming weeks.



TAXUS Liberte is the only second-generation drug-eluting stent approved for use in Japan. Design improvements over the Company’s first-generation TAXUS(R) Express2(TM) Stent include thinner struts to allow better stent deliverability and conformability, as well as a more uniform stent geometry for consistent lesion coverage and drug distribution.



“The TAXUS Liberte Stent is the latest advance in drug-eluting stent technology for Japan,” said Donald Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. “Its safety and efficacy have been well demonstrated in multiple clinical studies and years of clinical use.”



“We are very pleased with this approval, which provides access to proven technology to Japanese physicians and their patients,” said Jim Tobin, President and Chief Executive Officer of Boston Scientific. “We are committed to continuing to provide the most innovative products and therapies to the Japanese market.”



The TAXUS Liberte Stent uses proven paclitaxel-eluting technology, which has been evaluated by the industry’s most extensive randomized, controlled clinical trial program, and studied in 35,000 real-world patients enrolled in post-approval registries. More than 4.6 million TAXUS Stent Systems have been implanted globally.



The TAXUS Liberte Stent will replace the TAXUS Express2 Stent, which was launched in Japan in May 2007. It has been approved for sale in the United States, Europe and other international markets.



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 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 regulatory approvals, clinical trials, product performance 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 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.



Boston Scientific Corporation

http://www.bostonscientific.com

[Via http://www.medicalnewstoday.com]

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