The mitral valve is the heart valve that separates the left atrium from the left ventricle. It is composed of two leaflets that act as a check valve between the left atrium and the left ventricle, imposing a one-way flow of blood. It opens to allow blood to flow from the left atrium into the heart’s left ventricle. The mitral valve may fail to close completely due different pathologies. Therefore, the blood does not longer simply flows towards the aorta, but back through the diseased valve into the left atrium. This leak is known as mitral insufficiency or mitral regurgitation.

Mitral Regurgitation is the most common cardiac valve disease in developed countries. The disease prevalence increases with age and affects almost 10% of the population aged above 75 both in Europe and the US. In the USA it affects almost 6 million people and is the leading cause of valvular heart disease in the country. Moderate to severe mitral regurgitation is associated with 20% mortality at 1 year and 50% at 5 years. Severe mitral regurgitation which may be primary/organic (due to the elements of the valve apparatus) or secondary/functional (provoked by a deformation of the cardiac ventricular cavities, for example as a consequence of an infarct) frequently encounter a poor prognosis in absence of surgical treatment.

Several factors underlie this dynamic, including an increased number of patients with mitral insufficiency problems, an aging population, the evolution of minimally invasive device technology, the inclusion of patient populations that are currently untreated, regulatory approvals of devices, and more widespread knowledge of mitral regurgitation problems. Increased spending by payment and reimbursement systems for cardiac devices and valves is also a growth driver, particularly in developed countries. ICELAND targets the Mitral valve Repair (TMVre) market. This is a worldwide market that affects ≈10% of the population over the age of 75, a market that is naturally growing due to the aging of the population.