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Boston Scientific Announces CE Mark Approval and First Implants for New Devices to Treat Heart Failure and Sudden Cardiac Death

Fri, 11/19/2010 - 1:34am
Boston Scientific

NATICK, Mass., Nov. 19, 2010 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced CE Mark approval of its INCEPTA™, ENERGEN™ and PUNCTUA™ cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs).  They are the Company's latest devices to treat heart failure and sudden cardiac death.

These next-generation products are designed to advance patient care with options to expand appropriate therapy, optimize ventricular pacing and manage heart failure.  They are the world's smallest and thinnest high-energy devices and offer extended longevity over legacy platforms.

The first implants of INCEPTA™ ICDs and CRT-Ds occurred in Berlin, Germany at the Deutsches Herzzentrum Berlin (Stephan Goetze, M.D., Professor of Medicine); Herne, Germany at the Katholisches Marienhospital Herne (Hans-Joachim Trappe, M.D., Professor of Medicine); Linz, Austria at the Krankenhaus der Elisabethinen Linz (Siegmund Winter, M.D.); and Maastricht, The Netherlands at the Academisch Ziekenhuis Maastricht (An Moens, M.D.).  These initial implants are part of the NOTICE-HF study, which will evaluate and document the performance of the devices before full commercial launch, expected in the U.S., the Europe/Middle East/Africa region and certain Inter-Continental countries in the first half of next year.

"These devices offer physicians and their patients more options to customize therapy with new features designed to identify patient risks, while improving pacing and simplifying the implant," said Dr. Goetze, the Principal Investigator of the NOTICE-HF study.

"Boston Scientific looks forward to making these devices available to physicians and their patients," said Hank Kucheman, Executive Vice President and President of Boston Scientific's Cardiology, Rhythm and Vascular Group.  "This new portfolio of products, built on our tradition of innovation, provides multiple therapy options designed to match specific patient needs."

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 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 new product launches and launch cadence, regulatory approvals, clinical trials, 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.

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