Edwards Lifesciences has won the China's State Food and Drug Administration (SFDA) approval for its PERIMOUNT Mitral Heart Valve.
The PERIMOUNT valve, which is made of bovine pericardial tissue, is a replacement therapy designed to treat mitral valve disease.
The Valve is treated with the Carpentier-Edwards ThermaFix process, an anti-calcification tissue treatment that targets both major calcium binding sites that lead to tissue calcification.
Numerous peer-reviewed studies conducted on the replacement heart valve has demonstrated long-term endurance.
Fuwai Hospital and China National Heart Centre president Shengshou Hu said the PERIMOUNT 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.
"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 added.
The Carpentier-Edwards PERIMOUNT Mitral Heart Valve has also received the US Food and Drug Administration and CE mark approvals.