TAXUS® Element™ Stent now available in select markets worldwide
NATICK, Mass., May 19 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced the launch of the platinum chromium TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in select markets worldwide. The TAXUS Element Stent features a new platinum chromium alloy engineered specifically for coronary stent applications and represents the Company's third-generation drug-eluting stent (DES) technology.
The Element Stent series consists of three distinct versions: the Paclitaxel-Eluting TAXUS Element Stent, the Everolimus-Eluting PROMUS® Element™ Stent and the bare-metal Element Stent(1). All three versions of the Element Stent are built on the advanced platinum chromium platform and are designed to provide interventional cardiologists improved performance in treating patients with complex coronary artery disease. The Company is anticipating CE Mark approval for both the TAXUS Element Stent and the PROMUS Element Stent Systems in the fourth quarter of this year.
The platinum chromium alloy used in the Element Stent System was engineered specifically for coronary stenting, delivering both strength and flexibility. The Element Stent System platform also features a new stent architecture with thinner struts, increased flexibility and a lower profile, designed to improve radial strength, recoil and angiographic visibility. Deliverability to complex lesions is further enhanced through the incorporation of a new highly deliverable dilatation catheter technology.
"It is particularly important to have a range of options when selecting the right treatment for patients with challenging coronary lesions," said Dean J. Kereiakes, M.D., Medical Director at The Christ Hospital Heart and Vascular Center and The Lindner Research Center in Cincinnati, Ohio and a principal investigator for the TAXUS PERSEUS clinical trial evaluating the TAXUS Element Stent. "The Element Stent series is intended to provide a full range of DES solutions for interventional cardiologists, giving them the option to treat patients with a paclitaxel, everolimus or bare-metal stent. In my experience, the TAXUS Element Stent is a highly deliverable and conformable platform that has the potential to simplify complex procedures and improve outcomes."
"Our platinum chromium Element Stent series represents a significant leap forward in drug-eluting stent innovation," said David McFaul, Boston Scientific Senior Vice President, International. "This breakthrough technology combines a new alloy designed for coronary stenting, an innovative stent design and a new delivery system."
The TAXUS Element Stent System is currently being studied in the PERSEUS clinical trial program, which compares the TAXUS Element Stent System to the TAXUS® Express2® Stent System. The program includes the PERSEUS Workhorse and the PERSEUS Small Vessel arms. Both have finished recruiting patients and are estimated to be completed by the end of the year. The PROMUS Element Stent System is currently being studied in the PLATINUM clinical trial program, which compares the PROMUS Element Stent System to the PROMUS® Stent System, and is actively enrolling patients in the U.S., Europe and Japan.
While the Element Stent platform represents Boston Scientific's third-generation DES technology, the Company's fourth-generation DES is currently under development. Initial clinical data were presented at the Transcatheter Cardiovascular Therapeutics scientific symposium in 2008; global pivotal trials are expected to begin in 2010. This DES employs the Labcoat technology, which has an ultra thin biodegradable abluminal polymer that delivers a very low dose of paclitaxel to the wall of the treated vessel, and no polymer or drug on the inner surface of the stent. Integrating the Element Stent architecture and a platinum chromium alloy with an optimized drug release, the "Labcoat Element" Stent(2) is designed to deliver a powerful combination of procedural and clinical performance.
In the United States, the TAXUS Element Stent and PROMUS Element Stent are investigational devices and are limited by applicable law to investigational use only and are not available for sale.
The PROMUS Stent is a private-labeled Xience V® Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. Xience V is a trademark of the Abbott Laboratories group of companies.
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.
(1) TAXUS® Element™ and PROMUS® Element™ Drug-Eluting Stent Systems are CE mark pending; Element™ Bare-Metal Stent is under development. Not available for sale in the EEA (European Economic Area), U.S. and Japan.
(2) "Labcoat Element" drug-eluting stent system is under development. Not available for sale in the EEA, US and Japan.
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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 clinical trials, regulatory approvals, competitive offerings and product performance. 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.
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SOURCE: Boston Scientific Corporation
Web site: http://www.bostonscientific.com/