Successful First Implant of KingstronBio's ProStyle M® Mitral Valve System in National Study

First Implant of ProStyle M® Transcatheter Mitral Valve System

On March 12, 2026, a significant milestone in cardiac healthcare was achieved with the successful implant of the ProStyle M® transcatheter mitral valve system, developed by KingstronBio Technology (Changshu) Co., Ltd. This groundbreaking procedure took place under exclusive ultrasound guidance and is part of a national multicenter confirmatory study aimed at verifying the safety and efficacy of this innovative device.

The procedure was performed by distinguished cardiac surgeons, Professor Wang Chunsheng and Professor Wei Lai, from the Zhongshan Hospital affiliated with Fudan University, thus officially initiating the multicenter clinical trial that aims to validate the ProStyle M® system.

Previously, the system had undergone a comprehensive two-year initial human study, known as the First-in-Man (FIM) trial, involving ten patients with an average age of 71. The outcomes demonstrated exceptional anchoring with no cases of regurgitation, which underscores the potential of the ProStyle M® in treating mitral valve disorders.

Key Features and Innovations

KingstronBio, driven by innovation, has made significant strides in the field of cardiac valves. The ProStyle M® system integrates multiple proprietary technologies, including the Micro-Ex™ anti-calcification treatment and the AirBo™ dry storage technology, both of which are designed to enhance the performance and durability of heart valves.

The Micro-Ex™ technology effectively removes cellular debris and phospholipids from the pericardium, significantly delaying calcification and improving long-term durability. On the other hand, AirBo™ provides a unique method of preserving bovine pericardial tissue using an ionic liquid that retains molecular water, keeping collagen fibers flexible and functional.

Addressing Clinical Challenges

Mitral insufficiency (MI) stands as the most prevalent valvular heart disease in China. Despite advances, the field of transcatheter mitral valve replacement (TMVR) has historically faced complex anatomical challenges, including the risk of obstructing the left ventricular outflow tract and difficulties with valve anchoring and sealing. The ProStyle M® aims to tackle these issues with its eccentric structural design, which reduces surgical intervention difficulty while ensuring stable anchoring and good hemodynamic performance.

KingstronBio's Commitment

KingstronBio is fundamentally committed to revolutionizing the treatment of structural heart diseases. With a product range that includes bioprosthetic heart valves, annuloplasty rings, surgical biopatches, and pre-loaded transcatheter aortic valves, the company endeavors to provide safer and more reliable treatment options for patients with moderate to severe mitral insufficiency.

The company views research and development as the bedrock of its mission, with a team of experts leading substantial research initiatives in the field, resulting in multiple domestic and international patents. KingstronBio seeks to extend its innovation-driven approach to ultimately enhance the quality of life for patients suffering from cardiac conditions.

As it moves forward in its multicenter study, KingstronBio aims to gather more data that can verify the effectiveness and safety of the ProStyle M® system, solidifying its position at the forefront of cardiac treatment technology.

In summary, the first successful implant of the ProStyle M® marks a pivotal moment in the landscape of cardiac healthcare in China, offering hope for improved treatment options for patients with heart valve diseases. With a strong focus on innovation and development, KingstronBio is poised to continue its crucial work in this vital field.