Study to Assess Safety of the Pulmonary Valved Conduit (PV-001) in Subjects Undergoing Right Ventricular Outflow Tract Reconstruction

"The Bioabsorbable Pulmonary Valved (PV) Conduit (PV-001) is a polymer-based medical device, with a total length of 8 cm with inner diameters of 16 or 18 mm. The valve itself is formed by three leaflets, incorporated within the conduit wall.~The PV conduit is used for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) in patients with any of the following congenital heart malformations:~* Tetralogy of Fallot~* Truncus Arteriosus~* Pulmonary Atresia~* Transposition of Great Arteries with Ventricular Septal Defect (VSD)~* Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes~The PV conduit can also be used for replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits."