The study design is a multi-center, prospective, non-randomized study of up to 70 implanted subjects (US) with no site representing more than 30% of the implanted subjects. The subjects will include those subjects who have previously undergone placement of a conduit between the right ventricle and pulmonary artery and now present with a dysfunctional RVOT conduit requiring treatment for moderate or severe pulmonary regurgitation and/or RVOT conduit obstruction.