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Boston Scientific Announces Medicare Will Cover WATCHMAN(TM) Left Atrial Appendage Closure Device | ||
By: PR Newswire Association LLC. - 09 Feb 2016 | Back to overview list |
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MARLBOROUGH, Mass., Feb. 8, 2016 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced the Centers for Medicare and Medicaid Services (CMS) will cover percutaneous left atrial appendage closure (LAAC) therapy under specific criteria, as outlined in the agency's final National Coverage Determination (NCD). This decision, effective immediately, provides consistent and uniform access to the WATCHMAN™ LAAC Device as a non-pharmacological treatment option for stroke risk reduction for appropriate Medicare beneficiaries. "We are very pleased CMS has established national coverage for this life-changing therapy for Medicare beneficiaries who have a reason to seek an alternative to long-term anticoagulation," said Mike Mahoney, president and chief executive officer, Boston Scientific. "The final decision reflects more than a decade of robust clinical evidence and will facilitate additional data collection via a prospective national registry." The WATCHMAN Device, the first and only percutaneous LAAC therapy approved by the U.S. Food and Drug Administration (FDA) in March 2015, is indicated for patients with non-valvular atrial fibrillation (AF) who are at high stroke risk, suitable for warfarin, and are seeking an alternative to long-term warfarin therapy. According to the NCD, CMS will cover percutaneous LAAC therapy when specific conditions are met. CMS adopted the majority of physician and professional medical society feedback received in the 30-day public comment period, specifically as it relates to patient coverage criteria and future data collection requirements. Medicare beneficiaries account for the overwhelming majority of patients deemed candidates for the WATCHMAN Device. The remaining population is represented by private payers. Prior to the CMS final decision, a number of private payers, including several Blue Cross Blue Shield plans, have updated their policies to now cover the WATCHMAN Device. About the WATCHMAN LAAC Device About Boston Scientific 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. CONTACTS Media: Investors:
SOURCE Boston Scientific Corporation |
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Copyright 2016 PR Newswire Association LLC. | Back to overview list |