Congenital Heart Disease (CHD) affects approximately
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1,300,000
Newborns each year (globally)
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
TxGuard™ technology is designed to grow with the patient, thus reducing the risk of repetitive surgeries and alleviating the financial and emotional burden for families.
Unique Technology TxGuard technology is patented to be used for cardiovascular patches, valve conduit for CHD, and TAVR applications. It uses unique materials that are stable against enzymes and can slowly regenerate when implanted. TxGuard material exhibits high resistance to calcification as compared to glutaraldehyde x-linked tissues, which are currently used. TxGuard pulmonary conduit showed no tissue overgrowth, dilation, calcification, or thrombosis when implanted in sheep for a month-long period.
Soft Tissue Material One of the common procedures during complex surgeries is soft tissue repair. The pericardium is intended for use as surgical patch material for augmenting the patient’s own tissue to assist in closure following open-heart surgery, Intra-cardiac defects, septal defects and annulus repairs, cardiac and vascular reconstruction and repairs, peripheral vascular reconstruction and repairs, great vessel reconstruction and repairs, and suture-line buttressing. It is also used in urologic surgery, ophthalmology, abdominal hernias, and trachea repair.
Transcatheter aortic valve replacement (TAVR) is expanding rapidly as an alternative to surgery in newborns with severe symptomatic aortic stenosis (AS) who are at high risks for surgical valve replacement. However, these valves still use tissue material with glutaraldehyde crosslinked pericardium that was developed 50 years ago. We have a new treatment for these tissues that prevent calcification and keeps valves pliable for extended periods.