First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation

Inclusion Criteria: * Subject is aged less than 9 years at the time of the index procedure * Subject presents with hemodynamically significant discrete aortic coarctation or pulmonary artery stenosis requiring catheter-based intervention * Subject meets angiographic eligibility criteria at the time of the index procedure as assessed by the interventional cardiologist * Subject's legally authorized representative has provided written informed consent prior to any study-related procedures * Subject's physician has determined that catheter-based intervention is clinically indicated * Target vessel anatomy is suitable for stent implantation as assessed by the operator Exclusion Criteria: * Subject has complex aortic arch hypoplasia or long segment coarctation not amenable to stent therapy * Subject has a known allergy or hypersensitivity to zinc or silver * Subject has active systemic infection at the time of the index procedure * Subject has a contraindication to cardiac catheterization or general anesthesia * Subject has previously received a stent at the target vessel segment * Subject has a comorbid condition that in the opinion of the investigator would preclude safe participation in the study or confound study results * Subject is currently enrolled in another investigational device or drug study that has not completed its primary endpoint * Subject has a life expectancy of less than 12 months in the opinion of the investigator