Venus Medtech (Hangzhou) Inc., listed on the Hong Kong Stock Exchange as HKG: 2500, has reached a significant milestone with the implantation of its next-generation transcatheter aortic valve replacement (TAVR) system, Venus Vitae, in two patients as part of the global, multi-center pivotal SMART-ALIGN study. This prospective, randomized, interventional study is a key step in evaluating the safety and efficacy of the Venus Vitae valve system in patients with severe aortic valve stenosis.
The SMART-ALIGN study, anticipated to initiate in 20 medical centers across Europe, North America, and China, aims to enroll 150 subjects. The data gathered will be instrumental for regulatory submissions in key markets, including the European Union, Canada, and China. This development underscores Venus Medtech’s commitment to advancing cardiovascular care through innovative medical devices.- Flcube.com
