NATICK, Mass., Oct. 10 Boston ScientificCorporation (NYSE: BSX) today announced it has received approval from the U.S.Food and Drug Administration (FDA) to market its second-generation TAXUS(R)Liberte(R) Paclitaxel-Eluting Coronary Stent System. The Company plans tolaunch the TAXUS Liberte stent early next month in the United States,following completion of the introduction of its TAXUS(R) Expresss2(TM)Atom(TM) Paclitaxel-Eluting Coronary Stent System, which was approved by theFDA last month. The TAXUS Liberte stent was launched in Europe and otherinternational markets in 2005.
"The TAXUS Liberte stent represents our latest advance in drug-elutingstent technology," said Donald Baim, M.D., Chief Medical and ScientificOfficer of Boston Scientific. "This device has substantially thinner strutsand a more flexible cell geometry for improved deliverability, as well asuniform strut distribution designed specifically for drug elution. The TAXUSLiberte stent demonstrated similar late loss and target vesselrevascularization (TVR) as the TAXUS(R) Express2(TM) Paclitaxel-ElutingCoronary Stent System in the ATLAS Workhorse clinical trial, despite treatingmore challenging patients."
"We believe the approval of TAXUS Liberte is a clear indication that wehave made significant progress toward resolving the issues related to theCorporate Warning Letter," said Jim Tobin, President and Chief ExecutiveOfficer of Boston Scientific.
The TAXUS stent systems -- both Liberte and Express2 -- have beenevaluated by the industry's most extensive randomized, controlled clinicaltrial program, with follow-up to five years in some cases. These trialresults have been supplemented by data on more than 35,000 patients enrolledin post-approval registries. To date, approximately 4.6 million TAXUS stentshave been implanted globally, making them the world's most frequently useddrug-eluting stents.
The TAXUS Express2 stent (not the newer TAXUS Liberte stent) was used asthe control against the Xience(TM) V Everolimus-Eluting Coronary Stent Systemin the SPIRIT II and III trials. XIENCE is a trademark of the AbbottLaboratories group of companies.
The TAXUS Liberte Stent is not available for sale in Japan, where it isundergoing regulatory review.
Boston Scientific is a worldwide developer, manufacturer and marketer ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visit:www.bostonscientific.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaningof Section 21E of the Securities Exchange Act of 1934. Forward-lookingstatements 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 usinginformation available to us at the time and are not intended to be guaranteesof future events or performance. These forward-looking statements include,among other things, statements regarding regulatory approvals, clinicaltrials, product performance and competitive offerings. If our underlyingassumptions turn out to be incorrect, or if certain risks or uncertaintiesmaterialize, actual results could vary materially from the expectations andprojections expressed or implied by our forward-looking statements. Thesefactors, in some cases, have affected and in the future (together with otherfactors) could affect our ability to implement our business strategy and maycause actual results to differ materially from those contemplated by thestatements expressed in this press release. As a result, readers arecautioned not to place undue reliance on any of our forward-lookingstatements.
Factors that may cause such differences include, among other things:future economic, competitive, reimbursement and regulatory conditions; newproduct introductions; demographic trends; intellectual property; litigation;financial market conditions; and, future business decisions made by us and ourcompetitors. All of these factors are difficult or impossible to predictaccurately and many of them are beyond our control. For a further list anddescription of these and other important risks and uncertainties that mayaffect our future operations, see Part I, Item 1A - Risk Factors in our mostrecent Annual Report on Form 10-K filed with the Securities and ExchangeCommission, which we may update in Part II, Item 1A - Risk Factors inQuarterly Reports on Form 10-Q we have filed or will file thereafter. Wedisclaim 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 thatmay affect the likelihood that actual results will differ from those containedin the forward-looking statements. This cautionary statement is applicable toall forward-looking statements contained in this document.To view the Multimedia News Release, go to:http://www.prnewswire.com/mnr/bsci/34446/
SOURCE Boston Scientific