Huihe Medical Launches Nationwide Multicenter Clinical Trial of 2nd-Gen C-Wave® Coronary Intravascular Lithotripsy System
H&H Healthcare
R&D and Producer of Interventional Medical Devices for Heart Disease
2nd Generation C-Wave®The initiation of coronary shockwave was carried out by Zhongshan Hospital Affiliated to Fudan University.Academician Ge JunboChief Researcher and Conference Chair, Zhongshan Hospital Affiliated to Fudan UniversityProfessor Juying Qianand Tianjin University General HospitalProfessor Qing YangAs the host, Zhongshan Hospital Affiliated to Fudan UniversityProfessor Dai YuxiangThe First Affiliated Hospital of University of Science and Technology of ChinaProfessor Ma Likun, Fujian Medical University Union HospitalProfessor Chen Lianglong, The First Affiliated Hospital of Zhengzhou UniversityProfessor Han Zhan Ying, Tongji Hospital, ShanghaiProfessor Xuebo LiuQingpu Branch of Zhongshan Hospital Affiliated to Fudan UniversityProfessor Haibo Liu, Zibo Central HospitalProfessor Li Bo、The First Affiliated Hospital of Xi'an Jiaotong UniversityProfessor Guo Ning, Nanjing First HospitalProfessor Zhang Hongsong, Second Affiliated Hospital of Naval Medical UniversityProfessor Ding RuAnd Minhang Hospital Affiliated to Fudan UniversityProfessor Zhang PengNumerous cardiovascular disease experts participated in the conference and engaged in in-depth discussions on clinical trial protocols, laying the foundation for the research of a new generation of coronary shock wave systems in China.
C-Wave®The 1st generation coronary shockwave catheter was approved for marketing in 2024, featuring HuiHe Healthcare's globally pioneering S-shaped spiral electrode arrangement design and one-touch 4-wave uniform release, among other outstanding performances.
On this basis, HuiHe Healthcare has successfully developed the brand-new 2nd generation C-Wave.®Coronary Shockwave System significantly increases the discharge frequency and the number of discharges per single catheter. This iteration not only reduces the inflation time of the balloon in the coronary vessels but also allows a single catheter to address more lesion sites, reducing the number of balloons used and benefiting patients.
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Academician Ge Junbo
Academician Ge JunboFirst, the conference was addressed with opening remarks. As a new technology in the coronary field, coronary shockwave technology has been clinically applied in hundreds of hospitals across China, gradually generating multi-level clinical data. Academician Ge announced the launch of the second-generation coronary shockwave clinical trial led by HuiHe Healthcare, expressing hope to enrich the clinical evidence base for IVL in China, expand clinical indications, and further optimize the treatment pathway for calcified lesions in China. The goal is to leverage innovative devices and technologies to bring greater benefits to Chinese patients.
Professor Dai Yuxiang
Professor Dai YuxiangIntroduced the 2nd generation C-Wave®Multi-center Clinical Trial Protocol and Sharing of 2nd Generation C-Wave®The iterative design. It fully takes into account the severity of calcified cross-sections in Chinese patients and the continuity along the blood vessels, demonstrating strong recanalization capabilities for continuous calcification, nodular calcification, and eccentric calcified lesions.
Professor Juying Qian
Professor Juying QianAdditional supplementation: Moderate to severe coronary artery calcification can lead to stent delivery difficulties and incomplete stent expansion, thereby increasing the risk of stent failure and resulting in poorer long-term prognosis for calcified lesions. Therefore, adequate pre-treatment of calcified lesions is crucial. Two existing randomized controlled trials have shown that after using scoring balloons to treat severe calcified lesions, the stent expansion rate was only 70.8%, indicating room for improvement in efficiency. Additionally, there are currently no high-level evidence head-to-head studies comparing IVL with scoring balloons. Thus, the second-generation C-Wave...®The pre-market confirmatory study protocol is designed as a prospective, multi-center, randomized controlled trial, with substantial clinical significance.
Professor Chen Lianglong, Professor Ma Likun, Professor Yang QingThe attending experts shared their respective views and brainstormed on the clinical research protocol. The experts present engaged in detailed discussions on issues such as the calcification evaluation criteria, crossover to the opposite group for corresponding treatment after pre-processing failure, possible adverse events in the application of increased frequency coronary shock waves, and methods for handling these events, in order to better carry out this research in the later stages.
Experts on the Research Results and the New Generation of C-Wave®The coronary shock wave system has expressed high expectations, which is expected to promote the further development of the cardiovascular intervention industry and provide safer and more effective treatment methods for Chinese patients with cardiovascular diseases.
