Recently, the structural heart disease team led by Academician Ge Junbo, Professor Zhou Daxin, and Chief Physician Pan Wenzhi from Zhongshan Hospital, Fudan University, achieved a significant milestone in the development of domestic original medical devices. The multicenter clinical study results of their newly developed balloon-expandable aortic regurgitation valve with an anchoring device (Hanchor Valve System) were published as an original article in JACC: Cardiovascular Interventions (Impact Factor: 11.7), a top-tier international journal in the field of cardiovascular intervention. CCRC MedTech, as the clinical research organization (CRO) service provider for this project, participated in and supported the smooth implementation of the study throughout the entire process. With its professional execution team and stringent quality standards, CCRC MedTech ensured the efficient progress and data reliability of this innovative research, ultimately contributing to the recognition of the findings in this prestigious international journal.
Breaking Clinical Challenges: Hanchor Valve System Offers a New Treatment Option for Aortic Regurgitation Patients
Aortic regurgitation (AR) is a common yet clinically challenging valvular heart disease. Due to the lack of calcified anchoring points and annular dilation, traditional transcatheter aortic valve replacement (TAVR) devices face significant limitations in treating pure AR patients. The Hanchor Valve System, co-developed by the team from Zhongshan Hospital, Fudan University, and Shanghai Hanling Medical Device Co., Ltd., is the world’s first transfemoral balloon-expandable valve specifically designed for AR. Its innovative nitinol anchoring mechanism enables “auto-positioning” and secure fixation, significantly improving procedural safety and efficacy.
This multicenter clinical study involved 13 leading cardiac centers in China and enrolled 128 high-risk patients with severe AR. Key findings include:
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A procedural success rate as high as 96.09% (123/128)
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A 30-day permanent pacemaker implantation rate of only 12.00%, significantly lower than that of similar self-expanding valves
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Marked improvement in patients’ cardiac function (NYHA classification) post-procedure and low complication rates
These results signify China’s leap from “following” to “leading” in the field of AR interventional therapy, providing a superior minimally invasive treatment option for AR patients worldwide.
CCRC MedTech: Safeguarding Medical Device Innovation with Professional CRO Services
As the clinical research service provider for this study, CCRC MedTech leveraged its expertise and excellence in the medical device technology field to deliver high-quality clinical research services, including trial design, patient recruitment, data management, and statistical analysis. Working closely with the investigators, CCRC MedTech ensured the scientific rigor and reliability of the study, laying a solid foundation for the publication of the research results.
In an era of rapid advancements in medical technology, every groundbreaking medical device redefines the possibilities of life. The successful development and clinical validation of the Hanchor Valve System not only represent a major breakthrough in China’s structural heart disease treatment field but also highlight the value of the “physician-engineer collaboration” innovation model. By establishing a clinical research system that balances standardization and personalization, CCRC MedTech is helping more innovative projects bridge the “last mile” from the lab to clinical application.
Moving forward, CCRC MedTech will continue to deepen its professional advantages in strategic fields such as cardiovascular and neurointervention, building core competitiveness in specialized areas. At the same time, it will actively expand into emerging sectors such as AI, surgical robotics, and digital therapeutics, proactively shaping the future of medical innovation. Furthermore, CCRC MedTech is committed to aligning Chinese standards with international benchmarks, serving as a bridge for domestic innovations to enter the global market, and comprehensively supporting the leapfrog development of China’s medical device industry—from following and keeping pace to leading the way.
