Successful Implant of KingstronBio's Innovative Transcatheter Mitral Valve System Marks New Era in Heart Treatments

First Successful Implant of KingstronBio's ProStyle M® Transcatheter Mitral Valve System

On March 12, 2026, a pivotal moment in cardiovascular healthcare was achieved with the successful implantation of the ProStyle M® Transcatheter Mitral Valve System at Zhongshan Hospital, Fudan University. Conducted by renowned Professors Wang Chunsheng and Wei Lai under guidance of pure ultrasound, this procedure marks the beginning of a national multicenter confirmatory clinical study on this cutting-edge device, developed by KingstronBio Technology (Changshu) Co., Ltd.

This innovative valve system addresses a pressing need for effective treatments in the realm of mitral regurgitation (MR), the most prevalent valvular heart condition in China. Prior to this breakthrough, ProStyle M® underwent a thorough two-year First-in-Man study involving 10 patients with a mean age of 71. The results showcased impressive anchoring performance without any regurgitation, laying the groundwork for further investigations into its safety and efficacy.

The Technology Behind ProStyle M®

KingstronBio has pioneered several patented technologies, including the Micro-Ex™ anti-calcification treatment and AirBo™ dry storage technologies. These advancements are significant in enhancing the durability and overall performance of heart valves, ensuring they meet the rigorous demands of the human body.

Micro-Ex™ Anti-Calcification Treatment : This unique process effectively eliminates residual cell debris and phospholipids from the valve material. As a result, it noticeably delays calcification, which can shorten the lifespan of valve leaflets. This feature is essential for the long-term success of heart valves implanted in patients, particularly in challenging cases.

AirBo™ Dry Storage Technology: By utilizing an ionic liquid for the dry preservation of bovine pericardial tissue, this technology preserves vital molecular water that helps maintain tissue flexibility. This synergistic relationship between the Micro-Ex™ and AirBo™ technologies significantly enhances the valve’s long-term viability and biocompatibility.

Addressing Clinical Challenges in Mitral Valve Replacement

Mitral regurgitation poses unique challenges in heart valve replacement procedures, including complex anatomical structures and the risks associated with left ventricular outflow tract obstruction. However, the ProStyle M® valve's eccentric structural design aims to reduce these complexities while achieving stable anchoring performance.

The introduction of the ProStyle M® valve opens up possibilities that could revolutionize interventional therapy approaches for patients suffering from moderate to severe MR. As the clinical trial progresses, further data will solidify its place in the future of heart treatments.

KingstronBio's Vision and Commitment

KingstronBio's commitment to innovation and quality extends beyond just valve technology. The company is focused on developing an extensive portfolio of products for structural heart disease, inclusive of artificial bioprosthetic valves, annuloplasty rings, and cardiac surgical biopatches. By continuously investing in research and development, KingstronBio aims to provide reliable and safer options for Chinese patients facing heart diseases.

The journey towards enhancing cardiac care through advanced technology is just beginning. With the successful launch of the ProStyle M® Transcatheter Mitral Valve System, KingstronBio sets a new standard for heart valve treatments, ensuring a brighter healthcare future for many.