European Markets for Heart Valve Repair and Replacement Products

The basic parts of a native heart valve include a stationary annulus and flap-likecusps (or leaflets), which open and close with the flow of blood through the valve. An annulus is a ring of fibrous tissue at the base of the heart valve that surrounds the valve opening and supports the valve cusps. The mitral valve has two leaflets,while the aortic, pulmonary, and tricuspid valves have three leaflets. The proper functioning of the valve is dependent on a complex interaction of the annulus, the leaflets and, in the case of the tricuspid and mitral valves, the subval vularapparatus. The subvalvular apparatus consists of thin, fibrous strands called the chordae tendineae (or heartstrings) that attach the free edges of the valve leaflets to papillary muscles located on the ventricular wall and prevent the valve from being pushed open by the powerful pressure of blood being forced from the ventricle during contraction.

Heart valves act like a system of one-way doors to direct the flow of blood through the heart. Oxygen-depleted blood returns from the body to the “right” heart where it flows into the right atrium, through the open tricuspid valve, and into the right ventricle; the tricuspid valve then closes to stop blood from flowing backward into theright atrium. From the right ventricle, the oxygen-depleted blood is pumped through the pulmonary valve and into the lungs to take up oxygen. Oxygen-rich blood returns from the lungs to the “left” heart, where it flows into the left atrium, through the open mitral valve, and into the left ventricle; the mitral valve then closes to stop blood from flowing backward into the left atrium. From the left ventricle, the oxygen-rich blood is pumped through the aortic valve and on to the rest of the body,where it distributes its load of oxygen and then is returned to the right heart to beginthe cycle again. 

When one (or more) of the four heart valves does not close, closes incorrectly or incompletely, or becomes narrowed, blood flow through the heart is compromised, less oxygenated blood is pumped throughout the body, and the heart must work harder to compensate. Heart valve disorders may be congenital or acquired. Patients with congenital valvular disorders may be born with a heart valve that is the wrong size, or the valve leaflets may be malformed, not attached correctly, or simplymissing. Acquired heart valve disorders usually are the result of degenerative or calcific processes, infection (endocarditis), is chemia due to heart attack/failure, or trauma.  In cases of valvular narrowing or stenosis, blood flow through the heart valve is impeded, with a resulting reduction in the quantity of blood delivered to the chamber or vessel lying beyond the valve. In cases of valvular regurgitation (also known as insufficiency or incompetence), blood leaks backward through an improperly closed valve; depending on which valve is affected, the condition is calledaortic, mitral, pulmonary, or tricuspid regurgitation.  A patient may have a valve that exhibits both valvular stenosis and valvular regurgitation. 

It is expected that between the years 2010 and 2020, the population in the EuropeanUnion (EU) will increase from approximately 502 million to an estimated 511 million,and that by the year 2020, 20.2% of the population will be age 65 or older. The growing pool of older people living in the EU with heart valve disorders such asage-related aortic valve degeneration and symptomatic mitral valve regurgitation willcontinue to boost demand for heart valve repair/replacement procedures in theregion for the foreseeable future.