The first implant of the ProStyle M transcatheter mitral valve system was completed under pure ultrasound guidance as part of its confirmatory clinical study.
The device is independently developed by KingstronBio Technology (KingstronBio). The procedure was performed by Wang Chunsheng and Wei Lai of the Department of Cardiac Surgery, Zhongshan Hospital affiliated to Fudan University (Shanghai, China), marking the official launch of the national multicentre confirmatory clinical study for ProStyle M.
Prior to this, ProStyle M had undergone a two-year first-in-man (FIM) study involving 10 patients with a mean age of 71 years. The study results demonstrated excellent anchoring performance with no regurgitation observed in all cases. As the clinical study progresses, further evidence will be generated to verify the product’s safety and efficacy.
