NATICK, Mass., April 15 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today announced that it has received U.S. Food and Drug Administration (FDA) clearance for the two validated manufacturing changes affecting all of its cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs), and that it will immediately resume distribution of its COGNIS(R) CRT-Ds and TELIGEN(R) ICDs. The Company is positioned to fully meet customer demand for COGNIS and TELIGEN within 24 hours. COGNIS and TELIGEN represent virtually all of the Company’s defibrillator implant volume in the United States.
The Company’s pacemakers and other products were not affected by the ship hold and product removal actions. Geographies outside the United States were never affected - and remain unaffected - by these actions.
The Company is evaluating the impact of the ship hold and product removal actions on its financial results and will provide an update with the release of its first quarter earnings. These recent actions may have a material impact on the Company’s previously issued guidance, including revenue, operating profit and cash flows for the first quarter and full year of 2010.
Cautionary Statement Regarding 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.
Boston Scientific Corporation
