Prospective, non-randomized, open label clinical study to assess the feasibility of the Bioabsorbable pulmonary valved conduit in subjects undergoing Right Ventricular Outflow Tract (RVOT) reconstruction
This is a multi-center prospective, single-arm, non-randomized, open label study to assess feasibility of the Xeltis Bioabsorbable Pulmonary Valved Conduit in subjects requiring Right Ventricular Outflow Tract correction or reconstruction due to congenital heart malformations.
Are you Eligible? (Inclusion Criteria)
- 2-21 years of age
- Patient requiring RVOT reconstruction, suitable for 16 mm or 18 mm valved conduit.
- Male or female