KingstronBio Announces First Implant of ProStyle M Transcatheter Mitral Valve System in Confirmatory Study

April 20, 2026—China-based KingstronBio Technology (Changshu) Co., Ltd. announced the first implantation of the company’s ProStyle M transcatheter mitral valve system in a national multicenter confirmatory clinical study to verify the device’s safety and efficacy.

The company stated that the procedure, which was completed under pure ultrasound guidance, was performed by Professor Wang Chunsheng, MD, and Professor Wei Lai, MD, of the Department of Cardiac Surgery, Zhongshan Hospital Affiliated to Fudan University in Shanghai, China.

According to the company, KingstronBio independently developed the ProStyle M system. The device was previously evaluated in a 2-year first-in-human study composed of 10 patients (mean age, 71 years). The results demonstrated the device’s anchoring performance, with no regurgitation observed in all cases.

'The press release noted that features of the ProStyle M transcatheter mitral valve system include the following:

• An eccentric structural design to reduce procedural difficulty and the risk of left ventricular outflow tract obstruction, while achieving stable anchoring performance and good hemodynamic performance.
• KingstronBio’s Micro-Ex anticalcification treatment process to remove residual cell debris, phospholipids, and glutaraldehyde active groups in the pericardium that can effectively delay leaflet calcification and improve the long-term durability of leaflets.
• AirBo valve dry storage technology to enhance the durability and biocompatibility of the valve.