Forqaly Medical (Shanghai) Co., Ltd.

We are conducting a study to compare the effectiveness of a new heart support device called SynFlow 3.0 with ECMO (a commonly used heart and lung support machine) in patients with high-risk heart disease. The main goal of this study is to see if SynFlow 3.0 can provide similar or better support during heart surgeries compared to ECMO.
Specifically, we want to answer the following questions:
Can SynFlow 3.0 effectively support patients during heart surgeries, similar to ECMO? Is SynFlow 3.0 non-inferior to ECMO, meaning it is not worse than ECMO by a clinically acceptable margin? Does SynFlow 3.0 offer other benefits, such as better safety or lower costs, compared to ECMO? By answering these questions, we hope to determine if SynFlow 3.0 can be a viable alternative to ECMO for patients undergoing high-risk heart surgeries.