Healthcare Industry News:  cardiac resynchronization therapy 

Devices Cardiology Regulatory

 News Release - March 3, 2008

Boston Scientific Announces European Approval of New Heart Failure Lead

ACUITY(R) Spiral lead offers flexibility for placement in small, medium and large veins

NATICK, Mass., March 3 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced CE Mark approval of its ACUITY® Spiral left ventricular lead for use with cardiac resynchronization therapy defibrillators and cardiac resynchronization therapy pacemakers, both of which treat heart failure. The product features a spiral design and small lead tip profile (4 French) for placement of the lead even in difficult-to-access veins of varying sizes. A lead is an insulated wire that carries the heart signal to the implanted device and delivers energy from the device to the heart. In most cases, leads are passed into the heart through veins.

"The ability to place a left ventricular lead precisely where it will stimulate the heart most effectively is a key factor in providing patients with optimal cardiac resynchronization therapy," said Fred Colen, Executive Vice President, Operations and Technology, Boston Scientific Cardiac Rhythm Management. "ACUITY Spiral has the smallest lead tip profile in the industry and offers physicians the flexibility to place the lead in veins they may have avoided in the past."

The ACUITY Spiral lead is Boston Scientific's seventh U.S. or European regulatory approval in the past nine weeks. The ACUITY Spiral lead is pending approval by the U.S. Food and Drug Administration and is not available for sale in the United States.

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 our product performance, regulatory approval of our products, new product launches, competitive offerings, our growth strategy, and our market position. 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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