Congenital Heart Disease (CHD) affects approximately
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Of the 40,000 new patients found to have CHD each year in the US, primarily with conotruncal anomalies, 2,500 have a defect that requires a substitute, non-native conduit artery to replace structures that are congenitally absent or hypoplastic. Incidences of new CHD patients and the relative distribution of defects have not changed over time and remain a function of the birth rate.
Valve and conduit replacement procedures are required for medical situations such as the absence of pulmonary valve, aortic stenosis, double outlet right ventricle, extracardiac conduit, and pulmonary valve replacement. Most CHD patients will require a conduit and/or patch augmentation in the pulmonary circulation.
Current replacement materials have significant limitations, which result in the need for multiple re-interventions, ranging from interventional catheterizations with stent implantation to various operations for conduit replacement. These materials’ limitations are based on varying degrees of their thrombogenicity, durability, susceptibility to infection, and lack of growth potential.
- Any decellularized tissue (allograft, xenograft) can be physically stabilized so it retains its strength, pliability, and suture strength. It can be stored ready to use for two years.
- Immunogenic cellular materials are removed to make the scaffold less immunogenic.
- Antioxidant present in the tissue prevents oxidative damage to the tissue during remodeling.
- No in vitro bioreactor/stem cell manipulation required thus less stringent FDA requirement.
- TxGuard technology makes scaffold resistant to calcification and thrombosis.
- TxGuard promote remodeling of scaffold while reducing inflammatory response.
- Possibility of remodeling/growth especially for juvenile patients