Edwards Sapien 3 Transcatheter Heart Valve Approved in China

June 8, 2020—Edwards Lifesciences Corporation announced that it has received regulatory approval from China's National Medical Products Administration for the Sapien 3 transcatheter heart valve for the treatment of patients with severe, symptomatic aortic stenosis (AS) at high risk for or unable to undergo open-heart surgery. The valve is available in 20-, 23-, 26-, and 29-mm sizes.

The approval for high- and extreme-risk patients in China was supported by the Chinese SAPIEN 3 study, which complements clinical outcomes from three randomized controlled PARTNER studies as well as real-world results.

“Now, in China, patients diagnosed with severe AS have the option of a shorter procedure with excellent clinical outcomes, including a more rapid recovery than open heart surgery,” commented Professor Junbo Ge, MD, in the company's announcement. Professor Ge is academician of the Chinese Academy of Sciences; Chairman, Shanghai Institute of Cardiovascular Diseases; and Director, Department of Cardiology, Zhongshan Hospital, Fudan University in Shanghai, China.