Self-expandable stented valve with glutaraldehyde-fixed cardiac xenograft treated by novel anticalcification protocols including immunologic modification for perventricular pulmonic valve implantation

Method Porcine cardiac xenografts were treated by decellularization, immunologic modification with alpha-galactosidase, space filler, GA fixation in organic solvent, and detoxification. The nitinol (Nikel-Titanium, shape memory alloy) frame is comprised of a braided wire that reverts to its original shape and locks the valve into position as deployed. We manufactured the stented valve with the porcine cardiac xenografts mounted on a nitinol frame. The stented valves were implanted in ovine pulmonary valve position via perventricular approach, and durability was evaluated for 18 months after implantation.