| CryoValve® SG Pulmonary Human Heart Valve |
The Ideal Valve™ For RVOT Reconstruction & The Ross Procedure
The First And Only Decellularized Human Heart Valve Cleared By The FDA.
The SynerGraft® (SG) process virtually eliminates the presence of allogeneic donor cells,2 while maintaining the structural integrity of the tissue matrix. 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 (PRA) measured at up to one year, compared to the standard-processed pulmonary human heart valves. 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. PRA Results–SynerGraft Process Vs Standard Process Class I Alloantibodies After Implant 1 Brown J, Elkins R, Clarke D, Tweddell J, Huddleston C, Doty J, Fehrenbacher J, Takkenberg J. Performance of the CryoValve SG human decellularized pulmonary valve in 342 patients relative to the conventional CryoValve at a mean follow-up of four years. J Thorac Cardiovac Surg 2010;139:339-48. 2 Elkins R, Dawson P, Goldstein S, Walsh S, Black K. Decellularized human allografts. Ann Thorac Surg 2001;71:S428-32. |




