Heart failure occurs when the heart is not pumping enough blood as well as it should to support other organs in the body. This disease is the second leading cause of death in the US and in Europe, and causes repeated and extended hospitalizations. One out of every five patients dies within the year following diagnosis. Critical heart failure (HF) with short life expectancy affects 13% of the total HF population in Europe and the US.
1. AHA – Task Force. Heart disease and stroke statistics. Circulation 2012;125:e2-e220
The impetus for FineHeart’s 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 therapy until HF is advanced enough to warrant device-based intervention. Patients with Ejection Fraction below 35% and wide QRS complexes are eligible for cardiac resynchronization therapy (CRT), which has been shown to reduce mortality and hospitalizations [2,3], yet more than 40% of all HF patients do not respond to CRT at all.
Patients who continue to be symptomatic on optimized medical therapy and who have failed to respond to CRT are evaluated for left ventricular assist device (LVAD) placement, either as destination therapy (DT) or bridge to transplant (BTT). However, those traditional solutions fail to propose a large scale circulatory assistance.
2. Cleland JG, Daubert JC, Erdmann E et al.: The effect of cardiac resynchronization on morbidity and mortality in heart failure. N. Engl. J. Med. 352(15),1539–1549 (2005)
3. Bristow MR, Saxon LA, Boehmer J et al.: Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart failure. N. Engl. J. Med. 350(21),2140–2150 (2004).
Currently available LVADs are large, cause substantial myocardial damage, are subject to infection and thrombosis risk, and are therefore used in a small proportion of the HF population – those who are Class IV on the New York Heart Association (NYHA) scale, yet still well enough to handle the open-heart implantation that is required for most LVADs.
In order to better treat the advanced HF population, the FineHeart team has developed the Implantable Cardiac Output Management System (ICOMS) – a novel system that is a hybrid between an electrical and a mechanical device.
The ICOMS is a pulsatile smart pump, fully implantable and wirelessly powered, synchronized to heart’s innate contraction. The goal is to initially address NYHA Class IV patients and ultimately to expand to the NYHA Class III population in whom ICOMS could potentially slow progression of HF and in some, possibly lead to recovery by allowing the myocardium to rest and recover.