Extra-anatomic bypass or vascular shunts divert blood flow. In congenital heart disease, these surgical procedures are critical for management. Children born with one functional ventricle or cardiac pumping chamber require two to three major cardiac surgery procedures for palliation. The management goal is to divert systemic venous return (deoxygenated blood) from the heart directly to pulmonary artery circulation such that the single ventricle can pump oxygenated blood returning to the heart from the lungs to the body. These multiple surgical procedures carry significant morbidity and mortality, as well as incur substantial hospital costs secondary to lengthy hospital stays. A minimally invasive transcatheter approach would revolutionize the management of these children with congenital heart disease. No commercial alternatives exist for off-label medical use. Children born with ?single ventricle physiology? represent 7.7% of congenital heart disease diagnosed in childhood and have a birth incidence of approximately 4?8 per 10,000. In the United States, this represents approximately 2,000 children born each year. The commercial market is small enough to discourage the early development costs of a transcatheter cavopulmonary bypass endograft. There is a considerable unmet need for a purpose-built cavopulmonary anastomosis device.
