The China’s State Food and Drug Administration (SFDA) has granted approval to Edwards Lifesciences’ replacement heart valve, designed to treat mitral valve disease.
Made of bovine pericardial tissue, the Perimount Mitral Heart Valve is treated with the Carpentier-Edwards ThermaFix process, an anti-calcification tissue treatment that targets major calcium binding sites that lead to tissue calcification.
As reported in numerous peer-reviewed studies, the replacement heart valve has demonstrated long-term endurance.
Fuwai Hospital and China National Heart Centre president Dr Shengshou Hu said the valve provides an important therapeutic option for mitral valve replacement, particularly for patients whose lifestyles may not be compatible with the lifelong blood-thinning medication required with mechanical heart valves.
"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," Hu said.
The valve is also available in the US and the EU, following US Food and Drug Administration and CE mark approvals.
Edward Lifesciences heart valve therapy corporate vice president Donald Bobo Jr said the company is committed to bring life-saving heart valve disease therapies China.
"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," Bobo said.