- Randomized Study of Nearly 3,000 Patients to Evaluate Company'sThird-Generation Drug-Eluting Stent Technology
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Boston Scientific Corporation (NYSE: BSX) today announced the initiationof the PLATINUM PLUS clinical trial, an investigator-sponsored research (ISR)study designed to compare the performance of the PROMUS(R) Element(TM)Everolimus-Eluting Coronary Stent System to the XIENCE PRIME(TM)Everolimus-Eluting Coronary Stent System. The PROMUS Element Stent, whichreceived CE Mark in October 2009, is Boston Scientific's third-generationdrug-eluting stent technology and incorporates a platinum chromium alloy withan innovative stent design and an advanced catheter delivery system.
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PLATINUM PLUS is a prospective, randomized, multi-center clinical trialwith planned enrollment of 2,980 patients at 50 sites in France, Germany,Italy, Spain and the U.K. It will evaluate coronary revascularizationoutcomes in an unrestricted patient population randomized (2:1) to receive aPROMUS Element Stent or XIENCE PRIME Stent. The primary endpoint is 12-monthtarget vessel failure with planned follow-up out to 34 months. The trial isfunded by a research grant from Boston Scientific and led by PrincipalInvestigator Jean Fajadet, M.D., Clinic Pasteur, Toulouse, France andCo-Principal Investigator Eulogio Garcia, M.D., Clinico San Carlos, Madrid,Spain. Results are expected to be presented in 2012.
"We are very enthusiastic about beginning the first large-scalerandomized trial that compares the new platinum chromium PROMUS Element Stentwith the XIENCE PRIME Stent," said Dr. Fajadet. "The results shoulddemonstrate how two distinct stent platforms, with the same everolimus drug,perform in a head-to-head comparison."
The PROMUS Element Stent is designed specifically for coronary stenting.The novel stent architecture and proprietary platinum chromium alloy combineto offer greater radial strength and flexibility. The stent architecturehelps create consistent lesion coverage and drug distribution while improvingdeliverability, which is enhanced by an advanced catheter delivery system.The higher density alloy provides superior visibility and reduced recoilwhile permitting thinner struts compared to prior-generation stents[1].
The PLATINUM PLUS trial is coordinated by the Centre Europeen deRecherche Cardiovasculaire (CERC) under the direction of Marie-Claude Morice,M.D. CERC is an interventional cardiology clinical research organizationbased in Paris.
"This is an important study that could provide insights on the potentialbenefits of third-generation drug-eluting stents in an all-comers trialreflecting the daily clinical practice of interventional cardiologists," saidDr. Morice.
The PLATINUM PLUS trial will provide data that may complement BostonScientific's PLATINUM clinical trial, which completed enrollment of 1,531patients at 133 sites worldwide in September 2009. PLATINUM is a randomized,controlled, pivotal trial designed to support U.S. Food and DrugAdministration (FDA) and Japanese Ministry of Health, Labor and Welfare(MHLW) approval of the PROMUS Element Stent System.
In addition to offering the PROMUS Element Everolimus-Eluting CoronaryStent System in the European Union and other CE Mark countries, the Companyplans to launch the TAXUS(R) Element(TM) Paclitaxel-Eluting Coronary StentSystem in these markets next month. Both Element Systems incorporate the sameplatinum chromium alloy, innovative stent design and advanced catheterdelivery system. The Company expects FDA approval for the TAXUS Element StentSystem in mid 2011 and for the PROMUS Element Stent System in mid 2012. Itexpects MHLW approval for the TAXUS Element Stent System in late 2011 orearly 2012 and for the PROMUS Element Stent System in mid 2012.
In the U.S., the PROMUS Element and TAXUS Element Stent Systems areinvestigational devices and are limited by applicable law to investigationaluse only and are not available for sale.
XIENCE PRIME is a trademark of the Abbott Laboratories group of companies.
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:http://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. Theseforward-looking statements are based on our beliefs, assumptions andestimates using information available to us at the time and are not intendedto be guarantees of future events or performance. These forward-lookingstatements include, among other things, statements regarding clinical trials,regulatory approvals, competitive offerings, product performance and ourmarket position. If our underlying assumptions turn out to be incorrect, orif certain risks or uncertainties materialize, actual results could varymaterially from the expectations and projections expressed or implied by ourforward-looking statements. These factors, in some cases, have affected andin the future (together with other factors) could affect our ability toimplement our business strategy and may cause actual results to differmaterially from those contemplated by the statements expressed in this pressrelease. As a result, readers are cautioned not to place undue reliance onany 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 andour competitors. 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 hereafter. Wedisclaim any intention or obligation to publicly update or revise anyforward-looking statements to reflect any change in our expectations or inevents, conditions, or circumstances on which those expectations may bebased, or that may affect the likelihood that actual results will differ fromthose contained in the forward-looking statements. This cautionary statementis applicable to all forward-looking statements contained in this document.CONTACT: Paul Donovan +1-508-650-8541 (office) +1-508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann +1-508-650-8696 (office) Investor Relations Boston Scientific Corporation --------------------------------- [1] Based on bench testing. Data on file with Boston Scientific.
SOURCE Boston Scientific Corporation
