Unique two-sheet design

The bioprosthesis is attained by the unique two-sheet design: a tricusp shaped pericardium sheet is sutured to a second flat sheet using thread coated with a thin film of turbostratic carbon (Carbofilm™). The commissural areas, designed to absorb and distribute the mechanical stress during leaflet motion, present a unique cross-stitch suturing pattern. The two sheets are superimposed in a flat position so when the leaflets open they recover their original cylindrical configuration, hence, they are completely stress-free.

The elastic chain

The unique design creates a chain of smooth linkages with decreasing elasticity and represents the ideal condition for minimizing the concentration of tensional stress, especially during the closure phase. The presence of the second pericardium sheet (pericardial lining) is significant and makes the valve unique in that:
•its use contributes to the elastic chain
•it avoids contact and abrasion between the three leaflets and the fabric covered stent (synthetic material).

The fixation process

The bioprosthesis is constructed from glutaraldehyde-treated bovine pericardium.
Simultaneous in-depth tissue fixation and shaping are achieved by means of a fluidic, hence atraumatic system at low pressure. The detoxification process is then applied to the valve.