Abstract: The present invention concerns a tissue-engineered medical device, as well as a method for the production said medical device, comprising the following steps: providing a polymer scaffold comprising a mesh comprising polyglycolic acid, and a coating comprising poly-4-hydroxybutyrate; application of a cell suspension containing preferably human cells to the polymer scaffold; placement of the seeded polymer scaffold in a bioreactor and mechanical stimulation by exposure to a pulsatile flux of incremental intensity, thereby forming an extracellular matrix; mounting of the graft on a conduit stabilizer and incubation in cell culture medium; decellularisation of the graft in a washing solution; nuclease treatment of the graft; and rinsing of graft. The invention further comprises and various steps of quality control of the tissue-engineered medical device.

Abstract: The present invention concerns a tissue-engineered medical device, as well as a method for the production said medical device, comprising the following steps: providing a polymer scaffold comprising a mesh comprising polyglycolic acid, and a coating comprising poly-4-hydroxybutyrate; application of a cell suspension containing preferably human cells to the polymer scaffold; placement of the seeded polymer scaffold in a bioreactor and mechanical stimulation by exposure to a pulsatile flux of incremental intensity, thereby forming an extracellular matrix; mounting of the graft on a conduit stabilizer and incubation in cell culture medium; decellularisation of the graft in a washing solution; nuclease treatment of the graft; and rinsing of graft. The invention further comprises and various steps of quality control of the tissue-engineered medical device.

Abstract: Various inserts, called shapers and spacers, are provided for controlling tissue engineered heart valve (TEHV) leaflet geometry during culture. These inserts will prevent TEHV leaflet retraction during culture, be able to control the leaflet geometry during culture, enable culturing TEHV leaflets with a larger coaptation area, control the height of the coaptation area, maintain TEHV leaflet curvatures, and/or enable possibilities to culture TEHV leaflets in open configuration.