Summary: Heart Failure (HF) is the second cause of death in the G20 countries. It is a degenerative disease which, when becoming severe, may require device-based intervention. The ICOMS is a hybrid system implanted inside the left ventricle which combines a pacemaker together with a left ventricular assist pulsatile mini-propeller synchronized to the heart’s native activity. The implantable system is composed of a Pump (propeller + motor), an Electrical synchronization module (epicardial lead + connection to control board), a Control board (including synchronization algorithms and discrimination of non-physiological signals) and an Energy module in which the battery is recharged through a transcutaneous energy transfer (TET) system. The ICOMS physiologically supports native cardiac contractions by accelerating blood on a beat-to-beat mode towards the aortic valve. The beating heart surgical technique to implant the ICOMS is very similar to the one used for TAVI and is familiar to most cardiothoracic surgeons: the system is implanted via a mini-left thoracotomy and anchored in the apex of the left ventricle through a proprietary dedicated delivery system.
Need: The impetus for the ICOMS invention came from the founding team’s appreciation of the large unmet need in the advanced HF patient population. The current standard of care is medical management until HF is advanced enough to warrant implantation of a left ventricular assist device (LVAD). Currently available LVADs are bulky, require a percutaneous driveline for power delivery, may cause substantial myocardial damage, are potentially subject to infection, gastric bleeding, thrombosis risk, and are therefore used in a limited fraction of the HF population, those who are Class IVb on the New York Heart Association (NYHA) scale, yet still well enough to handle the open heart implantation that is required for most LVADs.
Value: FineHeart has developed the ICOMS since 2010: it is a minimally-invasive left ventricular pump implantable on a beating heart in a closed chest, with no percutaneous electrical connection. The device is targeted for the treatment of NYHA Class IV patients (similar to conventional LVADs today) as well as NYHA Class III patients due to its very small size, the simplicity of the surgical procedure and the absence of percutaneous external battery connections. The three main objectives of the ICOMS are:
1. To ensure at least a 30% increase in cardiac output when the device is synchronized to heart contraction (for NYHA Class III patients)
2. To ensure a continuous 5l/min of cardiac output if necessary such as conventional cardiac pumps on the market (for severe NHYA Class IVb patients)
3. To improve the patient’s quality of life while reducing overall healthcare costs. Among its key innovations, FineHeart has developed and patented an original propeller which confers several distinct yet closely related advantages:
a) Greater efficiency
b) Smaller size (allowing for minimally invasive implantation)
c) Lower overall power consumption (allowing for transcutaneous energy transfer)
d) Lower shear stress (leading to lower hemolysis rates).
The surgical technique to implant the ICOMS is very similar to the one used for TAVI and is familiar to most cardiothoracic surgeons: the device is implanted in a beating heart via a mini-left thoracotomy and anchored in the apex of the left ventricle through a proprietary dedicated delivery system.
Investigational Medical device not cleared for Human Use.