(By Balaseshan) Edwards Lifesciences Corp. (NYSE: EW) said 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.
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.
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.
"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 Bobo Jr., Edwards' corporate vice president, heart valve therapy.
Fuwai Hospital and China National Heart Center's President Shengshou Hu said 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.
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.
EW is trading down 0.82% at $83.37 on Wednesday. The stock has been trading between $62.69 and $110.79 for the past 52 weeks.