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FDA Clears Boston Scientific Corporation (BSX)'s Guidezilla™ Guide Extension Catheter


7/12/2013 9:56:24 AM

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Boston Scientific Launches Guidezillaâ„¢ Guide Extension Catheter in U.S. and Europe

NATICK, Mass.
, July 12, 2013 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration 510(k) clearance and CE Mark approval for the Guidezilla Guide Extension Catheter and has launched the device in the U.S. and Europe. The Guidezilla device is designed to make complex percutaneous coronary intervention (PCI) procedures easier by more efficiently delivering interventional devices, including balloons and stents, in situations where extra backup support is needed.

"The Guidezilla device provides a new level of confidence and reassurance in treating complex lesions," said John Lasala, M.D., director, Cardiac Catheterization Lab, Barnes-Jewish Hospital and director of Interventional Cardiology at Washington University, St. Louis, Mo. "I've found it can reduce the time and effort required in many complex procedures."

The stainless steel hypotube shaft provides pushability and kink resistance, and the hydrophilic coating on the outer-diameter reduces friction, making it easier for interventional cardiologists to navigate difficult to reach areas.

"Boston Scientific is committed to delivering innovative technologies such as the Guidezilla device that enable physicians to improve outcomes for patients undergoing complex coronary interventions," said Kevin Ballinger, president, Interventional Cardiology, Boston Scientific. "The Guidezilla guide extension catheter is a specialty device that provides physicians another compelling tool to help treat difficult lesions."

Coronary artery disease is the leading cause of death in the U.S.

Guide extension catheters are used in coronary angioplasty and stenting procedures which open arteries blocked by atherosclerosis. If left untreated, these blocked arteries can cause angina and heart attack.

For more information about the Guidezilla guide extension catheter, visit www.bostonscientific.com/guidezilla.

About Boston Scientific

Boston Scientific transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit www.bostonscientific.com and connect on Twitter and Facebook.

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, product performance and importance, 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.

CONTACT:

Ryan Davenport
763-494-2664 (office)
Global Media Relations
Boston Scientific Corporation
media@bsci.com

Michael Campbell
508-650-8023 (office)
Investor Relations
Boston Scientific Corporation
investor_relations@bsci.com

SOURCE Boston Scientific Corporation



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