ConFlow MedTech unveiled its innovative FreeFlow® transseptal shunt system at CSI Frankfurt 2023, a renowned conference dedicated to interventional heart treatment, held in Frankfurt, Germany, from June 28 to July 1, 2023. This event, with a two-decade history, highlights pioneering research in transcatheter interventions for cardiovascular diseases, aiming to address structural heart disease on a global scale.
During the CSI Frankfurt 2023 conference's Innovation & Device Development Forum, Dr. David Lin, a member of the Structural Heart Disease Team at Zhongshan Hospital affliated to Fudan University, showcased FreeFlow®, a product by ConFlow MedTech. He also explained the feasibility of left heart surgery using the "middle hole" approach.
In this report, our team, led by Academician Ge Junbo and Director Zhou Daxin, skillfully conducted left atrial appendage occlusion on an elderly patient diagnosed with atrial fibrillation. This patient had a FreeFlow® system implanted as a treatment for heart failure. FreeFlow® products have been used extensively in clinical cases, demonstrating their effectiveness in treating heart failure patients. This procedure, performed through the atrial septal channel created by the FreeFlow® system, served as a robust test of the system's stability and rapid endothelialization, which were fully validated.
This presentation kicks off by outlining the FreeFlow® structure and functionality and exploring its potential application in treating heart failure diseases (Figure 1).
Figure 1 FreeFlow® diagram
It has illustrates the essential components for future transseptal left heart surgery: the 5mm "middle hole" and rapid endothelialization resulting from FreeFlow® implantation (Figure 2).
Figure 2 Diagram of "Middle hole"
Three months post-implantation of FreeFlow®, successful left atrial appendage occlusion was achieved via “the Middle hole”.
(Video 1)
The experts in attendance engaged in constructive discussions about the study. Dr. Sameer Gafoor, a renowned expert in structural heart disease and interventional treatment for heart failure in the United States, commended the report. He expressed a strong belief in the potential of the FreeFlow® "Middle hole" approach to offer future solutions for heart failure and pulmonary diseases. Furthermore, it shed light on a new perspective for left heart surgery in patients with high-pressure implanted atrial shunts, while also acknowledging the innovative FreeFlow® device from China. Dr. Joseph Vettukattil from Helen DeVos Children's Hospital and Dr. Allison Cabalka from Mayo Medical Center participated in the discussion and provided their recognition for the shunt.
ConFlow MedTech's FreeFlow® percutaneous atrial septal shunt system, the first of its kind in Mainland China, boasts rapid endothelialization of its polymer membrane and secondary recovery. Its unique oval design minimizes implant size and is compatible with smaller conveyor systems. This technology holds multiple patent applications and maintains full intellectual property rights, representing an entirely original Chinese innovation.During the CSI conference, a case study demonstrated that left atrial appendage closure remains a viable option for heart failure and atrial fibrillation patients following FreeFlow® implantation, significantly expanding its clinical applications. On top of that, FreeFlow® implantation remains an option for heart failure patients expected to undergo future left heart surgeries.
（Video 2）
Expert profile
Ge Junbo
Academician of Chinese Academy of Sciences
At present, Academician Ge, the Director of Cardiology at Zhongshan Hospital affiliated to Fudan University, holds esteemed positions in cardiology and healthcare leadership. These honorable roles include presiding over the Cardiovascular Physicians Branch of the Chinese Medical Doctor Association, leading the China Cardiovascular Health Alliance, and directing the National Radiation and Therapy Clinical Research Center.
Throughout his career, he has garnered countless awards and honors, including "Yangtze River Scholar," "Science and Technology Elite," "National May Day Labor Medal," "Tan Jiazhen Life Science Award," and the "Bethune Medal." He is renowned for his pioneering work in ultrasound imaging diagnostics, specifically the "half-moon phenomenon" and "fingertip phenomenon" as myocardial bridge indicators. He also supervised the development of China's first degradable coating coronary stent and introduced the "Retrograde wire kissing technology" at the TCT conference in the United States.
Academician Ge has led groundbreaking medical breakthroughs, such as domestic percutaneous aortic valve implantation, percutaneous mitral valve repair, and percutaneous pulmonary angioplasty. His dedication to coronary artery disease diagnosis and treatment optimization, coupled with technological innovations, has resulted in achievements in intravascular ultrasound technology, new coronary stent development, complex coronary artery disease interventional strategies, and cell therapy for coronary artery disease.
With an extensive research background, he has been involved in over 20 national, provincial, and ministerial-level scientific research projects. He has authored more than 300 papers as the corresponding author, edited one English monograph, and co-edited 19 Chinese monographs. Furthermore, he serves as the editor-in-chief of influential cardiology textbooks and publications.
In recognition of his contributions, he has received prestigious awards, including the National Science and Technology Progress Award, the National Technological Invention Award, the Ministry of Education Science and Technology Progress Award, the Chinese Medical Science and Technology Award, and the Shanghai Science and Technology Progress Award. Academician Ge remains actively dedicated to advancing the field of cardiology and enhancing healthcare practices.
Zhou Daxin
Zhongshan Hospital Affiliated to Fudan University
Medical Director, Professor, and Doctoral Supervisor with exceptional expertise in congenital heart disease intervention, pulmonary arterial hypertension treatment, arrhythmia therapy, coronary heart disease treatment, hypertension, heart failure, and clinical pharmacology research. Significant contributions to the development of Chinese guidelines for structural heart disease diagnosis and treatment, pulmonary arterial hypertension guidelines, and expert consensus on treating congenital heart disease with severe pulmonary arterial hypertension. Furthermore, currently serving as Deputy Head of the Chinese Medical Association Structural Heart Disease Group, Deputy Chair of the Chinese Physician Association Cardiovascular Disease Branch Structural Heart Disease Special Committee, and Deputy Head of the Shanghai Cardiovascular Disease Association Structural Heart Disease Group.
Pan Wenzhi
Zhongshan Hospital Affiliated to Fudan University
Dr. Pan, a Doctor of Medicine and Chief Physician specialized in Cardiology and also serving as a Master Tutor. He holds multiple leadership roles within the Shanghai Medical Association's Cardiovascular Branch, including Deputy Leader of the Structural Cardiology Group, Secretary-General of China Structural Week, and Secretary of the Structural Group for the Cardiovascular Branch of the Chinese Medical Doctor Association. Furthermore, he is the Director of the R&D Department at the Chinese Cardiovascular Physician Innovation Club (CCI).
Dr. Pan has achieved significant recognition throughout his career, including being named one of the Top 10 Young Doctors at Fudan University in 2017, receiving the May 4th Youth Medal from the Shanghai Health Planning Commission in the same year, and being recognized as one of the Top 10 Outstanding Young Doctors of Fudan University in 2018. His accolades also include winning the Oriental Rising Star Award in 2019, securing the CIT Youth Research Award in 2020, and earning the prestigious Silver Snake Award, the top honor for young health talents in Shanghai, in 2021. Notably, he was promoted to the position of Chief Physician at the Shanghai Institute of Cardiovascular Disease in 2021, becoming the youngest to hold this title.
Dr. Pan's expertise is primarily in clinical practice and the development of devices for structural heart disease, with a special focus on transcatheter heart valve therapy (TVT). He has independently performed over 1,000 TAVR surgeries and played a pivotal role in crafting five Chinese expert consensus documents on TVT. Additionally, he holds 18 patents for inventions and utility models, including two international PCT patents, and has successfully commercialized 13 patents.
Collaborating with Academician Ge Junbo, he was a key team member in developing the world's first transapical mitral valve clamp, ValveClamp, which has completed pre-marketing clinical trials. He also contributed to the creation of the pioneering punctureable occluder known as ReAces, for which exploratory clinical trials have been completed. Furthermore, he edited the first domestic monograph on TVT titled "Transcatheter Heart Valve Therapy" and has authored over 50 SCI papers and more than 160 Chinese papers, with his research cited 1,928 times. Additionally, he played a role in editing two monographs.
Throughout his career, Dr. Pan has led five projects, including those funded by the national key R&D plan and the Shanghai Municipal Science and Technology Commission, earning recognition such as the first prize in the Ministry of Education's Science and Technology Progress Award in 2020 and the third prize in the Shanghai Science and Technology Progress Award in 2014.
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