On November 23, 2021, Professor Ge Junbo with his team of the Professor Zhou Daxin, Professor Pan Wenzhi and Physician Chen Shasha form Zhongshan Hospital of Fudan University (复旦大学附属中山医院) have been successfully completed the first transcatheter aortic valve replacement (“TAVR”) of HanchorValve, a balloon-expandable TAVR product with an anchoring structure developed by Shanghai Healing Medical Instruments Co., Ltd. (上海翰凌医疗器械有限公司)(“Healing Medical”), a subsidiary of Shanghai Kindly Medical Instruments Co., Ltd.（上海康德莱医疗器械股份有限公司）(“KDL Medical”)， which is also the first valve replacement operation that uses the balloon-expandable TAVR product with an anchoring structure to treat an 88-year-old patient with high surgical risk (STS score 8.1) for severe aortic regurgitation in the world.
The success achieved in the first clinical trial of HanchorValve marks the official launch of the national multi-center clinical trial with Zhongshan Hospital of Fudan University, which led by Professor Ge Junbo and his team. HanchorValve isthe first balloon-expandable TAVR product with an anchoring structure in the world that can treat both severe aortic regurgitation and severe aortic stenosis by transfemoral approach.
After the surgery, Professor Ge Junbo spoke highly of HanchorValve: HanchorValve pushes the TAVR from localization with operators experience in the past to autonomous localization now, like upgrade from manual to automatic. This will further expand the anatomical indications for the TAVR valve, shorten the learning time for TAVR, and make it easier for operators to treat more patients.
HanchorValve is the first TAVR product that Healing Medical has self-owned intellectual property rights, which is able to achieve precise and autonomous localization by virtue of its unique design of an anchoring structure. It is also the first balloon-expandable TAVR product by transfemoral approach in the world that can treat both severe aortic regurgitation and severe aortic stenosis.
The core members of the project team are from the China Cardiologists Innovation Club(“CCI”). The success of HanchorValve is a successful case of the "Medical Enterprise Cooperation" under the platform of CCl. The original concept of HanchorValve was proposed by CCI students, and then Healing Medical did the research and development. Since the establishment, CCI has been committed to creating an incubation and transformation platform for the whole process from innovative ideas to innovative transformation to innovative services. Through this platform, the idea of many clinicians can be successfully transformed. It is expected that CCI will be able to incubate and transform more original products in the future, so as to provide more high-quality Chinese solutions for the majority of patients.
Professor Ge Junbo,
HanchorValve is a balloon-expandable TAVR product with anchoring structure by transfemoral approach, which can treat the dual indications of severe pure aortic regurgitation and severe aortic stenosis. The valve can find the floor of aortic sinus autonomously, which push TAVR from localization with operators experience in the past to autonomous localization now, like upgrade from manual to automatic.
At the same time, the precise depth control of HanchorValve implantation effectively reduces the incidence of left bundle branch block, thus greatly reducing the implantation rate of permanent pacemakers.
In addition, HanchorValve uses a short stent design to effectively avoid myocardial ischemia caused by blocked coronary artery openings.
HanchorValve unique design shortens the learning time for TAVR, and make it easier for operators to treat more patients.
Professor Zhou Daxin,
The patient in this clinical trial was a patient with severe pure aortic regurgitation. During the surgery, HanchorValvewas very smooth to use, and we completed it in 31 minutes.
HanchorValve is also the first TAVR product that can be used to treat severe pure aortic regurgitation by transfemoral approach in China. In an aging society, the number of patients with aortic regurgitation exceeds the patients with aortic stenosis, HanchorValve will become a new weapon in the surgeons for the treatment of patients with aortic regurgitation.
Professor Pan Wenzhi
Firstly, congratulations to Healing Medical for the perfect success of TAVR of HanchorValve.
There are currently no mature products for the treatment of aortic regurgitation by transfemoral approach. Healing Medical uses the unique design to solve the worldwide technical problem, which is the treatment of severe pure aortic regurgitation by transfemoral approach. HanchorValve performance has reached the international leading level.
HanchorValve is an innovative valve product that will have broad application prospects in the treatment of pure aortic regurgitation.