First CFDA Approved Balloon-Expandable Transcatheter Aortic Valve Implantation



SAHZU Hospital President and Heart Center Chair Prof. WANG Jian'an and his team completed first two TAVR cases in China using Edwards Sapien 3, the first kind of balloon-expandable transcatheter aortic valve system that has attracted much attention since its approval by the Chinese FDA. This long-awaited official clinical application indicates that interventional cardiology in China has moved to the next page of TAVR device development.  

Edwards Sapien 3 is the first balloon-expandable transcatheter aortic valve system that enters China. It uses cobalt chromium alloy as its metal valve frame, exerting powerful force to the radial support that is more suitable for treating severely calcified heart valves. The artificial valve uses bovine pericardium tissue and its polyethylene terephthalate outer skirt can minimize paravalvular leak. This TAVR system has the biggest clinical evidence data with its over 25,000 enrolled patients worldwide. 455,00 patients have been implanted with the Sapien series of transcatheter aortic valve systems.