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Company plans to launch product immediately
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NATICK, Mass., Oct. 12 /CNW/ -- Boston Scientific Corporation (NYSE: BSX) today announced that Health Canada's Therapeutic Products Directorate (TPD) has licensed the PROMUS® Everolimus-Eluting Coronary Stent System for sale in Canada. The Company said it plans to launch the product immediately. The PROMUS Stent is currently for sale in the United States, Europe and other international markets.
The introduction of the PROMUS Stent in Canada expands Boston Scientific's drug-eluting stent (DES) portfolio in that market, where the TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent System is already offered. Boston Scientific is the only company to offer physicians the choice of two distinct drugs (paclitaxel and everolimus) on separate DES platforms.
"The PROMUS Stent has shown excellent deliverability, low late loss and the potential to reduce the need for re-interventions," said Dr. Eric Cohen, Director of the cardiac catheterization laboratory, Sunnybrook Heath Sciences Center in Toronto. "These benefits should make the PROMUS Stent an attractive treatment option for Canadian physicians and their patients."
The PROMUS Stent is a highly deliverable stent made from cobalt chromium, designed with thinner struts that do not sacrifice strength or visibility. The SPIRIT clinical trials indicate that the combination of the polymer/stent platform and the controlled release of the everolimus drug on the PROMUS Stent results in excellent deliverability, a strong safety profile and low levels of late loss.
Positive results for the PROMUS Stent were reported from the SPIRIT III clinical trial at this year's Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco, reaffirming the proven long-term safety and efficacy of the PROMUS Stent at three years.
"The PROMUS Stent complements our broad DES portfolio and further reinforces the leadership of Boston Scientific in the DES market as well as our commitment to continued innovation," said David McFaul, Boston Scientific Senior Vice President, International. "We are delighted that Canadian physicians and patients can now benefit from this highly advanced technology for the treatment of coronary artery disease."
The PROMUS Stent is a private-labeled XIENCE V® Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. The SPIRIT clinical trial program is sponsored by Abbott.
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-international.com.
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Cautionary Statement Regarding Forward-Looking Statements
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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 our product performance, regulatory approval of our products, new product launches, competitive offerings, our growth strategy, and our market position. 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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CONTACT: Paul Donovan
508-650-8541 (office)
508-667-5165 (mobile)
Media Relations
Boston Scientific Corporation
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Larry Neumann
508-650-8696 (office)
Investor Relations
Boston Scientific Corporation
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For further information: Media Relations, Paul Donovan, +1-508-650-8541 (office), +1-508-667-5165 (mobile), or Investor Relations, Larry Neumann, +1-508-650-8696 (office), both of Boston Scientific Corporation Web Site: http://www.bostonscientific-international.com
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