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CryoValve SG Pulmonary Human Heart Valves are indicated for the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic pulmonary valves. They may also be used in the replacement of native pulmonary valves when the Ross Procedure is performed. Pulmonary heart valve allografts are used to repair both congenital and acquired valvular lesions.

The CryoValve SG Pulmonary Human Heart Valve (CryoValve SG) is a human pulmonary heart valve aseptically recovered from donated human tissue from qualified donors. The valve is dissected, treated with an antimicrobial solution, and treated through the SynerGraft® (SG) process to remove the cells and cellular debris that have not already been removed during the postmortem period, harvesting, and the antimicrobial process. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below -135°C.

CryoValve SG is distributed in two anatomic configurations: pulmonary valve and conduit, and pulmonary valve.

Implantation of the CryoValve SG Pulmonary Human Heart Valve reduces the risk for induction of HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to the standard processed pulmonary human heart valve. Data have not been provided to evaluate the effect of reduced HLA class I and class II alloantibodies on the long-term durability, or long-term resistance to rejection by the patient, of the CryoValve SG.

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