A synthetic three-leaflet valve.

To increase durability and decrease calcification tendencies, the reduction of mechanical leaflet stress is of prime importance. In order to achieve this for a three-leaflet valve, the leaflets of a new design of prosthesis (the J-3) are manufactured in a medium open, almost flat shaped position, whereby the stent posts are expanded by a cone-shaped mold. Owing to this design, the leaflets have stable closed and open positions, the transition succeeds with low opening pressure. Valves are manufactured by dip-coating in polyurethane. Hydrodynamic evaluation of this polyurethane valve shows minimum pressure drop and very low energy losses compared with other commercially available valves. Very low shear stresses in the flow field downstream of the valve are observed by laser-Doppler-anemometry. In durability tests, prototypes have reached lifetimes equivalent to 17 years. For comparative testing of durability and biocompatibility, six bioprostheses and seven J-3 valves were implanted in mitral position of growing Jersey calves. While animal tests are encouraging, they also reveal necessary manufacturing improvements.