Major Breakthrough: Domestic ProStyle M Transcatheter Mitral Valve System Successfully Completes First Confirmed Clinical Implantation Under Pure Ultrasound Guidance

Apr 20, 2026 08:01 CST Updated 08:01

Kingstron Bio

Structural Heart Disease Product Developer in Cardiac Surgery

Breaking Good News in the Medical Community! On April 13, 2026, a heart valve system independently developed by a Chinese company completed the first implantation in its confirmatory clinical study, marking another solid and crucial step forward for China in the field of transcatheter mitral valve treatment!

This highly anticipated "China-produced black tech" is the ProStyle M Transcatheter Mitral Valve System independently developed by Kingstron Bio. Unlike traditional surgery, this...The first implant was completed entirely under pure ultrasound guidance, without reliance on radiation, ensuring patient safety and reducing radiation harm to medical staff, fully demonstrating the cutting-edge advantages of minimally invasive treatment. ✅

This milestone surgery was led by two experts from the Department of Cardiac Surgery at Zhongshan Hospital, Fudan University: Wang Chunsheng and Wei Lai. The success of the surgery not only signifies the official launch of the clinical application of the ProStyle M system but also marks the formal beginning of the system's nationwide multicenter confirmatory clinical study in China.

Preliminary Clinical Validation Results

Some friends may ask, is this Chinese-produced valve system reliable? The answer has long been hidden in the previous clinical data!

Before the launch of this confirmatory clinical study, ProStyle M had undergone a two-year First-in-Man (FIM) study, enrolling 10 patients with an average age of 71 – the high-risk group for mitral valve disease. The results were highly encouraging: after implantation in all patients, the valve demonstrated excellent anchoring, and no regurgitation was observed throughout, fully validating the core performance advantages of this product.

Product Technical Advantages

要知道，二尖瓣反流是中国最常见的心脏瓣膜疾病，传统开胸手术创伤大、风险高，很多高龄、高危患者难以耐受，而经导管二尖瓣置换术（TMVR）作为前沿微创技术，一直面临着锚定难、密封差等技术挑战。ProStyle M的出现，无疑为这类患者带来了新的希望。

It is reported that,ProStyle M, with its unique eccentric structure design, can effectively reduce the difficulty of surgical operation and the risk of left ventricular outflow tract obstruction. In addition, its equipped Micro-Ex™ anti-calcification technology and AirBo™ dry storage technology not only enhance the stability of the valve but also extend its long-term durability, precisely addressing clinical treatment pain points.

Patent Technology Drives InnovationMicro-Ex™ Anti-calcification Treatment Technology: A patented extraction technique using microemulsion to deeply remove cellular debris and phospholipids from the tissue, modify and eliminate aldehyde groups, significantly reducing valve calcification levels, which has been validated in standard animal models. AirBo™ Dry Membrane Treatment Technology: Dry preservation of bovine pericardial tissue achieved through a special ionic liquid, retaining molecular water to maintain the flexibility of fibrous collagen. The synergistic effect of Micro-Ex™ anti-calcification technology and AirBo™ dry preservation technology can significantly enhance the anti-calcification performance and long-term durability of the valve.

R&D Process

And the birth of this "China-made heart equipment" was not an overnight success, but rather the result of years of dedicated efforts by Kingstron Bio. Its research and development process was clear and solid, outlined in chronological order as follows:

Enterprise Foundation and Technical Accumulation

In 2012, Kingstron Bio was officially established, focusing on the research and development of innovative medical devices for structural heart disease, laying a solid corporate foundation for the development of ProStyle M. The company subsequently expanded its product range to include a full series of heart valve products, accumulating extensive technical expertise.

As a platform-based high-tech enterprise deeply engaged in the field of cardiac valves, Kingstron Bio is a national-level specialized and innovative "little giant" enterprise. Headquartered in Yushan High-Tech Zone, Changshu, Jiangsu, the company has a registered capital of approximately 99 million yuan and owns a comprehensive production plant covering over 20 acres with a building area of about 10,000 square meters. It is equipped with a modern GMP Class 10,000 clean production area, complete supporting facilities, and has passed the ISO13485 quality management system certification. With innovation as its core driving force, the company is led by Zhong Shengping, a specially appointed expert of Beijing, and has formed a professional R&D team consisting of doctors and masters from home and abroad. After years of dedication to the valve field, the company has mastered several core patents such as Micro-Ex™ anti-calcification technology and AirBo™ dry storage technology, and has cumulatively obtained 55 domestic and international patents.

Since its establishment, Kingstron Bio has always adhered to the concept of "being a technology pioneer rather than a follower." Starting with surgical valve product lines in its early days, the company gradually achieved a full range of product layouts, including surgical bioprosthetic valves, annuloplasty rings, biological patches, transcatheter aortic valve replacement (TAVR), and interventional mitral valves. It is one of the companies with the most comprehensive product lines in this field in China. Its developed annuloplasty rings, bioprosthetic valves, and biological patches were successively approved for marketing in 2018, 2021, and 2022. The sister product, ProStyle Aortic Valve System, became the world's first retrievable pre-mounted valve to enter NMPA registration clinical trials, providing solid technical support and experience for the development of ProStyle M. Additionally, the company once led the national "12th Five-Year Plan" science and technology support program, successfully developing globally leading anti-calcification technology and achieving industrialization. With strong technical capabilities, it has promoted Chinese-produced valve products to break international monopolies, contributing to the localization process and reducing patients' financial burdens.

Early Clinical Exploration

In December 2023, the cardiac surgery team at Zhongshan Hospital Affiliated with Fudan University successfully completed the world's first eccentric design pre-loaded dry valve TMVR surgery using the ProStyle M system under pure ultrasound guidance. Post-surgery, the patient’s mitral regurgitation disappeared, and the valve anchoring effect was excellent, providing valuable clinical practice data for subsequent product development.

In February 2024, the team once again utilized the ProStyle M large valve (TM45) to complete a TMVR surgery for a patient with degenerative mitral regurgitation, further verifying the product's clinical applicability; in the same year, the related technologies of the ProStyle series products continued to improve, with its sister product, the ProStyle aortic valve system, advancing in the clinical process, providing a more solid technical reference for the development of ProStyle M.

FIM Study Phase

From 2024 to March 2026, ProStyle M officially enters the two-year First-in-Human (FIM) study phase, enrolling a total of 10 patients with an average age of 71 — consistent with the FIM study data mentioned earlier. The study results show no regurgitation in all patients post-implantation, with excellent anchoring performance, further solidifying the core safety and efficacy of the product and laying a solid foundation for subsequent pivotal clinical studies.

Confirmatory Clinical Study Initiation

On March 12, 2026, ProStyle M successfully completed the first implant in the confirmatory clinical study under pure ultrasound guidance; on April 13 of the same year, relevant clinical progress was officially disclosed, marking the product's entry into a new phase of clinical validation. Its China-based multi-center confirmatory clinical study has also officially commenced.

Future Outlook

As the multi-center confirmatory clinical research in China progresses, ProStyle M will accumulate more real-world clinical data, further comprehensively verifying its safety and efficacy. In the future, this innovative product made in China is expected to provide a safer, more minimally invasive, and more reliable treatment option for more patients with moderate to severe mitral regurgitation, breaking international technical barriers and safeguarding the "heart" health of Chinese people ❤️

Let us look forward to the day when this domestically-produced "heart" equipment completes clinical research, becomes widely available, and benefits more patients, further advancing the treatment of structural heart disease in China!