Healthcare Industry News: PROMUS
News Release - November 29, 2007
Boston Scientific Welcomes FDA Panel Recommendation to Approve PROMUS(TM) / XIENCE(TM) V Everolimus-eluting Coronary Stent SystemNATICK, Mass., Nov. 29 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today welcomed the recommendation of a U.S. Food and Drug Administration (FDA) advisory panel to approve with conditions the PROMUS(TM) / XIENCE(TM) V everolimus-eluting coronary stent system. The PROMUS and XIENCE V stent systems are identical products, sold respectively by Boston Scientific and Abbott in international markets. Both stent systems would be covered by the same FDA approval.
"Today's recommendation is a significant step toward making Boston Scientific's two-drug program a reality in the United States," said Hank Kucheman, Senior Vice President and President of Boston Scientific's Cardiovascular business. "Once approved in the United States, the PROMUS stent system -- together with our proven and market-leading TAXUS stent technology -- will enable Boston Scientific to offer physicians and their patients a choice of two distinct drugs, each on a highly deliverable stent platform."
The PROMUS and XIENCE V stent systems are investigational devices in the U.S. and not yet approved for sale. PROMUS is a private-labeled XIENCE V everolimus-eluting stent system manufactured by Abbott and distributed by Boston Scientific.
TAXUS and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE 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.
Cautionary Statement Regarding Forward Looking Statements
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, product performance and competitive offerings. 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.
Source: Boston Scientific
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