Also today at EuroPCR, Edwards announced the receipt of CE Mark approval for sale in the European Union of the NovaFlex+ transfemoral delivery system for use with the next-generation Edwards SAPIEN XT transcatheter heart valve. This new system incorporates modifications focused on improving ease of use and is designed to make valve alignment prior to deployment more reliable. Edwards is launching this system, as well as the eSheath expandable sheath technology, at EuroPCR. The eSheath, which received CE Mark earlier this year, enables the use of a low profile sheath and is designed to reduce vascular complications. The Edwards SAPIEN valve, Edwards SAPIEN XT valve, NovaFlex+ and eSheath are investigational devices not yet available commercially in the United States.
About Edwards Lifesciences
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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 www.edwards.com.
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, statements regarding potential clinical results and benefits of the Edwards SAPIEN and Edwards SAPIEN XT valves, the NovaFlex+ system and the eSheath. 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 actual results or experience 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 results following expanded clinical experience and market developments. These and other 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, 2010.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, eSheath and NovaFlex+ are trademarks of Edwards Lifesciences Corporation.
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