Method of Processing Collagen-based Tissue for Bioprosthetic Devices

A bioprosthetic heart valve assembly having a plurality of leaflets, wherein each of the plurality of leaflets is a collagen-based pericardial tissue that is made by a method comprising:

• a) harvesting a pericardial tissue from a host animal;
• b) cleaning the harvested tissue;
• c) fixing the cleaned tissue using glutaraldehyde;
• d) treating the fixed tissue with a solution consisting of 20% to 70% alcohol and 0.1% to 1% polysorbate 20 in pH 7.0-7.5 buffered saline at 30° C. to 60° C., wherein the alcohol is either ethanol or isopropanol;
• e) treating the treated tissue from step (d) with 0.1% to 1.0% detergent solutions containing one or more of the following detergents:
• Sodium Deoxycholate (SDC), Sodium dodecyl sulfate (SDS), 3-[N,N-Dimethyl(3-myristoylaminopropyl) ammonio]propanesulfonate, Amidosulfobetaine-14 (ASB-14), 3-[(3-cholamidopropyl) dimethylammonio]-1-propanesulfonate (CHAPS);
• and
• f) treating the treated tissue from step (e) using 65% to 75% alcohol, wherein the alcohol is either ethanol or isopropanol.