NATICK, Mass., June 26, 2012 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) welcomes final passage today by the United States Senate of "The Food and Drug Administration Safety and Innovation Act." The bill reauthorizes medical device user fees negotiated as part of a comprehensive agreement between the medical device industry and the FDA, and includes other significant policy reforms. This critical legislation sets important accountability, transparency and efficiency expectations of the FDA medical device review process.
"This bill provides for the opportunity to accelerate the introduction of innovative medical devices without compromise to patient safety," said Hank Kucheman, chief executive officer at Boston Scientific. "We are hopeful that these reforms will have a strong and lasting impact on the FDA's ability to address lengthening review times, spur innovation and promote faster patient access to new therapies. We appreciate the collective effort undertaken by Chairman Harkin, Senator Enzi, Chairman Upton and Congressman Waxman to speed this important bipartisan bill through Congress. We look forward to working with the FDA on the implementation of the bill."
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 the impact of the medical device tax. 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 Corporation