The aim of this new three-leaflet valve development was to design a leaflet with minimum membrane stresses during performance. This is achieved by manufacturing the valve leaflets shaped almost flat in a medium opening position. Thus, the leaflets have two stable positions, one with maximum opening area and the other with favorable stress distribution in the closed position. The transition between the two end positions is achieved through a two-dimensional rolling motion without buckling and with minimum membrane stresses (bulge forces). The manufacturing technique is dip-coating in polyurethane. Hydrodynamic evaluation of the J-3 valve in steady and pulsatile flow showed minimum pressure drop compared to other commercially available valves. Laser-Doppler-anemometry studies indicated very low shear stresses in the flow field downstream of the valve. In durability tests prototypes have reached lifetimes of up to 17 years. In conclusion, the J-3 valve shows superior hydrodynamic performance thereby reducing potential thrombus formation. Minimization of stresses within the valve leaflets through design could reduce calcification.

The novel sewing ring concept consists of a detachable ring snap connection between valve housing or stent and suture cuff. The suture cuff itself is a memory metal ring of nickel-titanium (NiTi) that is embedded within a textile fabric torus. After a special training program the ring can assume two geometric shapes when alternately cooled and heated. Due to this physical property, the sewing ring can be safely fixed within a groove of the housing or stent by changing between room and physiological temperature. This allows the surgeon first to implant the sewing ring followed by arbitrary positioning and final fixation of the valve by the shape-memory effect. Additional advantages are an increased stiffening of the valve base for minimizing potential leaflet dysfunction, and reduced time and risk of implantation, particularly when a reoperation is necessary.