IRVINE, CA--(Marketwire - Nov 28, 2012) - Edwards Lifesciences Corporation ( NYSE : EW ), the global leader in the science of heart valves and hemodynamic monitoring, today announced that it has received approval from China's State Food and Drug Administration (SFDA) for its Carpentier-Edwards PERIMOUNT Mitral Heart Valve, a replacement heart valve made of bovine pericardial tissue.
"The PERIMOUNT Mitral Heart Valve provides an important therapeutic option for mitral valve replacement, particularly for those patients with lifestyle considerations that may not be compatible with the lifelong blood-thinning medication required with mechanical heart valves," said Shengshou Hu, M.D., president of Fuwai Hospital and China National Heart Center. "This valve offers excellent hemodynamics and established long-term durability, providing Chinese surgeons with an important new, yet clinically established, treatment for their patients suffering from mitral valve disease."
Designed for the treatment of mitral valve disease, the PERIMOUNT Mitral Heart Valve was introduced into clinical use in 1984 and has demonstrated long-term endurance, as reported in numerous peer-reviewed studies. The valve is treated with the Carpentier-Edwards ThermaFix process, the only anti-calcification tissue treatment that targets both major calcium binding sites that lead to tissue calcification. Edwards' family of PERIMOUNT pericardial valves have been the world's most frequently implanted valves for more than 30 years.
"The approval in China of our market-leading PERIMOUNT Mitral Heart Valve represents a clinically significant advancement for patients in the country suffering from mitral heart valve disease," said Donald E. Bobo, Jr., Edwards' corporate vice president, heart valve therapy. "We are committed to bringing life-saving therapies that treat heart valve disease to Chinese surgeons and their patients."
The Carpentier-Edwards PERIMOUNT Mitral Heart Valve was approved for U.S. commercial distribution in 2000 and bears the CE mark for countries in the European Union.
About Mitral Valve Disease
Mitral valve disease causes the valve's leaflets to malfunction in one of two primary ways. When the mitral valve is affected by mitral regurgitation, the leaflets weaken and cannot close properly, so blood leaks backward within the heart; with mitral stenosis, the leaflets stiffen due to the accumulation of calcium and the opening of the valve narrows, restricting normal blood flow.
About Edwards Lifesciences
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, Dr. Hu or Mr. Bobo's statements and statements regarding potential clinical benefits of the PERIMOUNT Mitral Valve. 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 clinical outcomes following expanded clinical experience and unexpected 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, 2011.
Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, PERIMOUNT and ThermaFix are trademarks of Edwards Lifesciences Corporation.
Sarah Huoh or Janet Kim
David K. Erickson