Medicare to Cover Transcatheter Heart Valve Procedure
(firmenpresse) - IRVINE, CA -- (Marketwire) -- 05/02/12 -- Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, announced that, effective immediately, the Centers for Medicare & Medicaid Services (CMS) will reimburse transcatheter aortic valve replacement (TAVR) procedures for U.S. patients with symptomatic aortic stenosis under specified criteria.
The company commended CMS for issuing a flexible National Coverage Determination (NCD) that authorizes coverage for current and future indications approved by the U.S. Food and Drug Administration (FDA). Edwards also noted that, under the NCD, coverage would extend to qualified non-inferiority or equivalence clinical studies. Additionally, important but small patient populations can be covered under a qualified study. The company continues to support the collection of TAVR outcomes data in a qualified national prospective registry.
"We endorse the NCD's emphasis on the use of multi-disciplinary heart teams in the treatment of TAVR patients," said Michael A. Mussallem, Edwards' chairman and CEO. "While we are still analyzing the policy and its lengthy supporting decision memorandum, we believe that this policy can provide appropriate and prompt access to treatment for these very sick patients."
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at .
This news release includes 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. These forward-looking statements include, but are not limited to, Mr. Mussallem's statements, and statements regarding potential outcomes, benefits and risks of a National Coverage Determination for transcatheter valve replacement. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement.
Forward-looking statements involve risks and uncertainties that could cause the outcomes to differ materially from those expressed or implied by the forward-looking statements based on a number of factors including but not limited to unexpected regulatory decisions, expanded clinical experience, and market developments. These factors are detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2011.
Edwards, Edwards Lifesciences and the stylized E logo, are trademarks of Edwards Lifesciences Corporation.
Sarah Huoh or Janet Kim
949-250-5070
David K. Erickson
949-250-6826
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Datum: 02.05.2012 - 07:00 Uhr
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