A new porcine bioprosthesis: design rationale and early clinical experience.

The Medtronic Intact valve is a third-generation porcine bioprosthesis produced using a leaflet fixation process which imposes virtually zero hydrostatic pressure. This fixation method provides optimal preservation of the original leaflet structure and integrity and should result in an improvement in durability compared to conventional preservation techniques. The biomechanical basis for this hypothesis is presented along with early experience with 118 patients (125 valves). There have been no complications related to primary valve failure and the incidence of other valve related events is acceptable.