On the afternoon of January 3, 2024, the kick-off meeting of FreeFlow Percutaneous Atrial Septal Shunt Registration Clinical Research was held in Zhongshan Hospital Affiliated to Fudan University. It was a prospective and multi-center registered clinical trial, with Academician Ge Junbo of Zhongshan Hospital Affiliated to Fudan University as the main researcher and seven centers in China participating in the research.

Professor Zhou Daxin, Professor Pan Cuizhen, Professor Pan Wenzhi, Professor Guan Lihua and Dr. Li Wei attended the kick-off meeting, which was chaired by Professor Guan Lihua. Professor Zhou Daxin delivered an opening speech, analyzed the research on shunts at home and abroad, and shared the clinical treatment experience of the Zhongshan Hospital structural team in pulmonary arterial hypertension. Finally, the participating experts and the company's clinical operation team carefully studied the clinical trial plan, trial process and related laws and regulations, and successfully completed the clinical-related work of the kick-off meeting. The successful convening of this kick-off meeting marks the official launch of the national multi-center registered clinical trial of FreeFlow percutaneous atrial septal shunt with Zhongshan Hospital affiliated to Fudan University as the lead unit! FreeFlow has achieved a milestone in clinical research on pulmonary arterial hypertension!

pulmonary arterial hypertension (PAH) is a clinical and pathophysiological syndrome caused by the changes of pulmonary vascular structure and/or function caused by various causes and different pathogenesis, which leads to the increase of pulmonary vascular resistance and pulmonary artery pressure, and then develops into right heart failure and even death. Idiopathic pulmonary arterial hypertension (IPAH) has an annual mortality of about 10% and is incurable, and the mortality of some diseases such as scleroderma-related PAH is even higher.

For patients with right heart failure caused by pulmonary arterial hypertension, there are still obvious symptoms of right heart failure after combined and standardized targeted drug therapy, and atrial septal shunt provides a brand-new treatment scheme for them. Implantation of shunt in patients with right heart failure can relieve hemodynamics, improve heart function and increase exercise tolerance, which is expected to become a milestone technology to relieve pulmonary arterial hypertension, and then improve the survival status of patients with right heart failure caused by pulmonary arterial hypertension. At present, atrial shunt in China is still in the clinical trial stage, and no products have been approved for marketing.

FreeFlow percutaneous atrial septal shunt is a pulmonary arterial hypertension treatment device independently developed by Shanghai ConFlow MedTech Co., Ltd. This device is the world's first atrial septal shunt system with rapid endothelialization of polymer membrane and secondary recovery. The unique oval design reduces the volume of implants and can be matched with a smaller delivery system. This device has applied for many patents and has complete independent intellectual property rights. It is a real original research technology in China.

The FIM clinical trial of FreeFlow percutaneous atrial septal shunt has been completed, and the clinical data show that the cardiac function and quality of life of patients have been continuously improved after operation. The smooth development of multi-center registered clinical trials will lay a solid foundation for the registration and marketing of products, and it is expected to benefit more patients with pulmonary arterial hypertension in the future.