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News Release - March 1, 2012
Boston Scientific Announces Launch of PROMUS Element(TM) Platinum Chromium Stent System in JapanNext-generation coronary stent employs innovative alloy designed to improve acute performance
PROMUS Element now approved in all major markets worldwide
NATICK, Mass., March 1, 2012 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (NYSE: BSX ) announces the launch of the PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent System in Japan. The product was recently approved by the Ministry of Health, Labor and Welfare. The PROMUS Element Stent System incorporates a platinum chromium (PtCr) alloy with an innovative stent design and an advanced catheter delivery system designed to provide physicians improved drug-eluting stent performance in treating patients with coronary artery disease. The Company plans to begin marketing the product immediately in Japan.
"We are very pleased to launch the PROMUS Element Stent System to Japanese physicians and their patients," said Yusuke Naiki, President of Boston Scientific Japan. "This everolimus-based stent system complements our broad coronary intervention portfolio and reinforces our global leadership in the drug-eluting stent market."
The PROMUS Element Stent uses a proprietary PtCr alloy designed specifically for coronary stenting, which enables enhanced visibility, less recoil, excellent conformability and higher radial strength. It employs an advanced low-profile delivery system to enable precise stent placement across challenging lesions. The everolimus drug and fluorinated copolymer used on the PROMUS Element Stent have been studied in multiple randomized clinical trials and registries. The PROMUS Element Stent expands Boston Scientific's PtCr drug-eluting stent portfolio in Japan, which also includes the TAXUS® Element Paclitaxel-Eluting Platinum Chromium Coronary Stent System.
"This approval marks two important milestones for Boston Scientific," said Hank Kucheman, Chief Executive Officer of Boston Scientific. "First, the PROMUS Element Stent platform is now approved in every major market worldwide. Second, we have begun the last phase of our transition to higher margins on our everolimus stent offering as we shift to the internally manufactured PROMUS Element Stent. Boston Scientific remains the only company to offer physicians a choice of two proven drug and polymer combinations on an innovative coronary stent platform."
The Company received CE Mark approval for the PROMUS Element Stent System in 2009 and for the PROMUS Element Plus Stent System in 2011. In the U.S., the PROMUS Element Plus Stent System was approved by the Food and Drug Administration (FDA) in 2011. The TAXUS® Element™ Paclitaxel-Eluting Stent System received Japan approval in 2011 and CE Mark approval in 2010. It is commercialized in the U.S. as the ION™ Paclitaxel-Eluting Stent System, where it received FDA approval in 2011.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices that 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 27A of the Securities Act of 1933 and 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 business plans, new product launches and launch cadence, product performance, future gross margin contributions 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 hereafter. 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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