Imagine a tiny, smart pump that sits inside the heart and works like a helper, pushing blood along with the natural heartbeat. Unlike older pumps, it has no wires poking through the skin, which means no open doors for germs to enter. It's designed to be low-energy and wireless, making it much safer and more comfortable for the patient.
Current heart failure devices often cause infections due to skin-crossing wires and bleeding due to non-physiological blood flow. This leaves 95% of severe heart failure patients without a suitable treatment option.
A miniaturized, wireless, pulsatile intracardiac assist system. The project delivered over 50 clinical-grade devices and a validated manufacturing process.
If you are a cardiac implant manufacturer dealing with high infection rates in traditional heart pumps — this project developed a wireless intracardiac assist device that removes the driveline crossing the skin to suppress infection risks.
If you are a cardiology clinic dealing with the 95% of severe heart failure patients who currently lack a viable solution — this project developed the ICOMS FlowMaker® to restore quality of life through physiological blood flow.
If you are a MedTech investor dealing with a lack of EU-sovereign heart failure treatments — this project developed a first-in-class pulsatile system aiming for EU market entry in 2026.
Based on available project data, the specific unit price or cost of the device is not mentioned.
Yes, the project has already qualified industrial processes, including clean rooms, and produced over 50 clinical-grade devices.
The project report mentions sustained efforts in IP portfolio management, though specific licensing terms are not provided.
The project aims to enter the EU market in 2026, followed by the US market, and has already received formal approval for its dossier from the ANSM.
It is implanted inside the left ventricle and synchronizes with the natural heartbeat to push blood in a physiological way.
The project is led by a single SME, FINEHEART, based in France. With a 100% industry ratio and a total EU contribution of EUR 2,500,000, the structure is lean and focused on commercialization rather than academic research, which is reflected in the rapid TRL advancement from 5 to 8.
Contact FINEHEART in France
Contact us to explore partnership opportunities with FINEHEART for the 2026 EU market launch.
