Descripción del proyecto
The ICOMS FlowMaker® is the first intracardiac assist device that overcomes all shortcomings of current and under development devices and restores patient's quality of life. Its design perfectly fits all the needs of patients suffering from severe heart failure. Implanted inside the left ventricle and synchronized with natural heartbeat, it assists the heart to push blood in a physiological way. The very low electrical consumption allows for wireless functioning. With no driveline crossing the skin, the risk of infection is suppressed. Without bypass to aorta and thanks to its pulsatile mode, the risk of bleeding is very low. The ICOMS FlowMaker® addresses the market of severe heart failure, where 95% of patients are left without any solution. The aim of the project is to conduct the clinical trials to enter the EU market in 2026, then the US market, allowing to finally achieve EU sovereignty in severe heart failure treatment.