Development of a cardiac valve substitute: the Smeloff-Cutter prosthesis.

Several criteria were used for the development of the Smeloff-Cutter prosthesis: (a) the valve must permit adequate pulsatile forward flow with minimal gradients and regurgitation; (b) materials used must be inert or compatible with tissue and blood; (c) the prosthesis must be durable; (d) attachment must be easy and secure; (e) the valve must be nonhemolytic and nonthrombogenic; (f) its geometry must not impinge on surrounding structures; (g) testing must be in vitro as well as in vivo; and (h) its use must result in an acceptable long-term clinical response. Application of these criteria to the design of the Smeloff-Cutter valve is described.