On November 24, 2021, a Zhongshan Hospital team, led by Academician Ge Junbo and including Prof. Zhou Daxin, Prof. Guan Lihua, Prof. Pan Wenzhi, Prof. Zhang Xiaochun, Prof. Li Wei, Dr. Chen Dandan, and Dr. Li Mingfei, successfully employed ConFlow MedTech's FreeFlow® percutaneous atrial septal shunt system in an elderly patient with refractory heart failure and severe mitral regurgitation. The patient exhibited significant clinical symptom improvement, decreased atrial pressure, increased cardiac output, reduced mitral regurgitation, and enhanced exercise tolerance post-surgery. This achievement offers a promising alternative to conventional heart failure treatment.

Heart failure, a prevalent outcome of myocardial disease stemming from various causes, affects a substantial number of individuals. Epidemiological data reveals that the United States has 6.2 million adult heart failure patients, while China's larger population results in an excess of ten million cases. Without effective treatment, chronic heart failure has a less than 50% five-year survival rate, and acute heart failure boasts a staggering 60% five-year mortality rate.

In recent years, the rising cardiovascular incidence has led to an increasing number of heart failure patients. Research suggests that the average hospital stay for these patients is 9.7 days, with 40.5% being hospitalized more than three times annually. For individuals over 80 years old, the average hospitalization duration lasts 12.2 days, and 44.2% of them have received at least three hospital treatments. This places a considerable burden on China's healthcare system and poses a potentially greater challenge in the future.

Academician Ge Junbo, Director Zhou Daxin, and Prof. Guan Lihua from Zhongshan Hospital affiliated to Fudan University, demonstrated foresight when they applied for and obtained a patent for a room partition diverter in 2016. At present, they actively promoted industry-university research collaboration projects to society as a whole, with a dedicated focus on creating a percutaneous room partition shunt system. Their aim is to further enhance the quality of life for heart failure patients and alleviate the burden on the national healthcare system. ConFlow MedTech has not only leveraged this patent but also expanded it to create subsequent patent designs. They've invested significant resources in developing the FreeFlow® percutaneous atrial septal shunt system.

ConFlow MedTech is a technology company specializing in the R&D, production, and industrial operation of cardiovascular innovative medical devices. Through continuous independent R&D and clinical transformation of cutting-edge high-tech, we are committed to becoming a first-class innovative product manufacturer with international influence. The management team of ConFlow MedTech has been actively involved in the field of structural heart disease for more than a decade. It is composed of senior experts in project operation, R&D and production, clinical quality registration and marketing. Nestled in the heart of Songjiang Science and Technology City, Shanghai Lingang Group proudly occupies a spacious 2,200-square-meter complex. This facility boasts a pristine environment featuring a 10k Grade clean workshop, well-equipped laboratories, a machining platform, and modern office spaces. Now the company's product line covers heart failure treatment equipment, valve repair and peripheral vascular treatment equipment.

ConFlow MedTech's FreeFlow® transseptal shunt system, the first of its kind in China, boasts rapid endothelialization of high-molecular-weight membranes and the ability for secondary retrieval. Its distinctive elliptical design reduces implant size and enables compatibility with smaller delivery systems. This technology holds multiple patents, full intellectual property rights, and stands as a genuine product of Chinese R&D innovation.

An elderly patient with a 13-year history of recurrent shortness of breath, aggravating over the past six months, underwent FreeFlow® percutaneous atrial septal shunt system treatment. Preoperative assessments revealed the following measurements: mean pulmonary capillary wedge pressure at 15mmHg, pulmonary artery pressure at 21mmHg, left atrial pressure at 17mmHg, right atrial pressure at 5mmHg, and cardiac output at 3.2. Echocardiographic data shown a left ventricular ejection fraction of 29%, left ventricular diameter of 71mm, and severe mitral valve regurgitation.

During the procedure, a FreeFlow® device was implanted through femoral vein access, establishing a stable left-to-right shunt. Postoperative left-to-right atrial shunt index measured 1.4.

Postoperatively, measurements indicated mean pulmonary capillary wedge pressure at 11mmHg, pulmonary artery pressure at 14mmHg, left atrial pressure at 10mmHg, right atrial pressure at 3mmHg, and cardiac output at 3.8. Echocardiographic data showed a left ventricular ejection fraction of 29%, left ventricular diameter of 67mm, and moderate mitral valve regurgitation.

To sum up, after FreeFlow® percutaneous atrial septal shunt system implantation, the patient experienced reduced pressure in both left and right heart chambers, lowered pulmonary artery pressure, increased cardiac output, and diminished mitral valve regurgitation.

In early 2022, the FreeFlow® percutaneous atrial septal shunt system will initiate a nationwide multi-center clinical trial led by Academician Ge Junbo, offering hope to a larger number of heart failure patients.