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Boston Scientific Announces First Implants Of Next-Generation Implantable Defibrillator In Europe

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices
Article Date: 14 Jan 2008 - 15:00 PDT

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Boston Scientific Corporation (NYSE: BSX) announced the first implants in Europe of its CONFIENT™ implantable cardioverter defibrillator (ICD), which received CE Mark approval in October 2007. The procedures were performed in Germany by PD Dr. Alexander Bauer, University Hospital Heidelberg; Dr. Sascha Stiller, University Hospital Ulm; Dr. Johannes Sperzel, Kerckhoff Klinik Bad Nauheim; and Dr. Konstantin Heinroth, University Hospital Halle (Saale).

"The advanced rhythm management options provided by this defibrillator can help manage complex arrhythmias for people at risk of sudden cardiac death," said PD Dr. Alexander Bauer, University Hospital Heidelberg (Head: Prof. Dr. Hugo A. Katus). "The CONFIENT ICD benefits patients because it is designed to distinguish between potentially lethal and non-lethal heart rhythms."

The CONFIENT ICD features wireless capability designed to save physicians time during implant by allowing device programming during wound closure while also eliminating the need for a programmer communication device in the sterile field. CONFIENT also saves time at follow-up with communication between the programmer and device that can be three times faster as compared to the Company's non-wireless telemetry.

"The CONFIENT ICD is a tangible example of the meaningful product innovation under way in our Cardiac Rhythm Management group," said Jim Tobin, President and Chief Executive Officer of Boston Scientific. "We look forward to making this ICD broadly available to physicians so they can offer this advanced therapy to patients who are at risk of sudden cardiac death."

Sudden cardiac death is the abrupt loss of heart function, usually due to an electrical rhythm dysfunction in the lower chambers of the heart (known as ventricular fibrillation). Each year, sudden cardiac death claims the lives of as many as 350,000 people in Europe alone. More people die from sudden cardiac death each year than from lung cancer, breast cancer and AIDS combined.

An ICD is a small implantable device about the size of a box of matches that is placed under the skin just below the collarbone. The device uses leads (wires threaded into the heart's chambers) to monitor every single heartbeat. If a potentially deadly rhythm is detected, a lifesaving shock is delivered, restoring normal heart rhythm and preventing sudden cardiac death.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.

Boston Scientific Corporation.

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 our product performance, regulatory approval of our products, our growth strategy, and our market position. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialise, 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.

Boston Scientific Corporation.




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