www.fdanews.com/articles/181564-cfda-approves-venus-medtechs-tavr-device
CFDA Approves Venus Medtech's TAVR Device
May 1, 2017
China–based Venus Medtech has received approval from the China Food and Drug Administration (CFDA) for its Venus A-valve.
The company’s transcatheter aortic valve system, Venus A-valve, provides a less invasive treatment solution for inoperable and high-risk patients.
The study showed the implantation success rate was 95 percent and the 30-day all-cause mortality was 5 percent.
The company will launch a global trial for the third generation TAVR device at the end of 2017. — Cynthia Jessup