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"We are pleased to reach this important milestone in the development ofour third-generation drug-eluting stent, at a time when most companies arestill introducing their first-generation stents in the U.S.," said KeithDawkins, M.D., Senior Vice President and Associate Chief Medical Officer forBoston Scientific. "Boston Scientific is the only company to offerinterventionalists a choice between two different drugs in a DES platform.The advanced Platinum Chromium Alloy and new balloon catheter offered in theElement system will further strengthen our deep portfolio of coronary stenttechnologies."
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The Element Stent platform features the proprietary Platinum ChromiumAlloy, designed specifically for stents. This alloy, coupled with aninnovative new stent architecture, is designed to enable thinner struts forincreased flexibility, a lower profile, and improved radial strength, recoil,and radiopacity. In addition, the TAXUS Element Stent System incorporates newballoon technology, intended to improve on Boston Scientific's market-leadingMaverick(R) Balloon Catheter platform.
"The new alloy and stent design of TAXUS Element provides improveddeliverability and visibility, even in patients with complex and challenginganatomy," said Dean J. Kereiakes, M.D., Medical Director at The ChristHospital Heart and Vascular Center and The Lindner Research Center inCincinnati and the principal investigator for the trials. "I am veryenthusiastic about the potential the TAXUS Element Stent offers me to treat abroader range of patients."
The TAXUS PERSEUS clinical program will evaluate the efficacy and safetyof the TAXUS Element Stent in two studies.
The first study, TAXUS PERSEUS Workhorse (A Prospective Evaluation in aRandomized Trial of the Safety and Efficacy of the Use of the TAXUS ElementPaclitaxel-Eluting Coronary Stent System for the Treatment of De Novo CoronaryArtery Lesions), will evaluate the safety and efficacy of the TAXUS ElementStent compared to Boston Scientific's first generation drug-eluting stent, theTAXUS(R) Express(TM) Stent. This 3:1 randomized study will evaluate 1,264patients from 94 sites in the U.S., Australia, New Zealand and Singapore with"workhorse" lesions from 2.75 to 4.0 millimeters in diameter. The primaryendpoint of the workhorse study is target lesion failure (TLF) at 12 months,and its secondary endpoint is in-segment percent diameter stenosis at ninemonths.
A second parallel study named the TAXUS PERSEUS Small Vessel study willcompare the TAXUS Element Stent to a historic control (TAXUS V de novobare-metal Express(R) Coronary Stent System). This study will include 224patients from 35 U.S. sites with lesions from 2.25 up to 2.75 millimeters.The primary endpoint of the small vessel study is in-stent late loss at ninemonths, and its secondary endpoint is TLF at 12 months.
The TAXUS Element Stent is an investigational device and is limited byFederal law to investigational use only and is not available for sale. BostonScientific is currently seeking CE Mark approval in European markets, which isanticipated in 2009.
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 clinical trials, regulatoryapprovals, competitive offerings, product performance and our market position.If our underlying assumptions turn out to be incorrect, or if certain risks oruncertainties materialize, actual results could vary materially from theexpectations and projections expressed or implied by our forward-lookingstatements. These factors, in some cases, have affected and in the future(together with other factors) could affect our ability to implement ourbusiness strategy and may cause actual results to differ materially from thosecontemplated 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; 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.CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation
SOURCE Boston Scientific Corporation
