Healthcare Industry News: thrombosis
News Release - February 1, 2012
Boston Scientific Announces First Implant and Market Launch of PROMUS Element(TM) Plus Stent System in EuropePlatinum chromium coronary stent with enhanced delivery system now available in Europe and other international countries
NATICK, Mass., Feb. 1, 2012 -- (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (NYSE: BSX ) announces first patient use and European market launch of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System. The first patient implant in Europe using the new device was performed by Professor Antonio Colombo, M.D., Director of the Cardiac Catheterization Laboratory at Columbus Hospital and San Raffaele Hospital in Milan, Italy. The new stent system incorporates the platinum chromium (PtCr) alloy and innovative stent design of the PROMUS Element Stent with an enhanced catheter delivery system engineered for improved deliverability in treating patients with coronary artery disease. The Company plans to begin marketing the product in select European and other CE Mark countries immediately and will expand to a full market launch in the second quarter.
"The PtCr alloy and stent architecture used in the Element platform offer significant advantages in conformability and radiopacity compared to other stent platforms," said Dr. Colombo. "I believe the improved deliverability of the PROMUS Element Plus Stent System will add another significant benefit, especially when accessing challenging lesions. This innovative stent is also supported by strong clinical outcomes from the PLATINUM trials, which demonstrated very low rates of revascularization and stent thrombosis at one year."
The PROMUS Element Stent, found on the PROMUS Element Stent System and the PROMUS Element Plus Stent System, uses a proprietary PtCr alloy designed specifically for coronary stenting, which enables enhanced visibility, less recoil, excellent conformability and higher radial strength. The PROMUS Element Plus Stent System employs an advanced low-profile delivery system featuring a dual-layer balloon designed to enable precise stent delivery across challenging lesions and reduce balloon growth during inflation to facilitate high-pressure stent deployment. The everolimus drug and fluorinated copolymer used on the PROMUS Element Stent have been studied in multiple randomized clinical trials and 'real-world' registries, demonstrating excellent long-term safety and efficacy.
"We are proud to introduce the PROMUS Element Plus Stent System to physicians and patients in Europe and other CE Mark countries," said Michael Onuscheck, President, Europe, Middle East and Africa at Boston Scientific. "It is the latest example of Boston Scientific's commitment to market leadership and continued innovation in drug-eluting stents."
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 CE Mark approval in 2010 and 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 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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