Autus Valve Pivotal Study

Inclusion Criteria:

Candidates must meet all of the following inclusion criteria to be considered for enrollment in this study.

1. Age 18 months to 16 years.

2. Male or female.

3. Subject has a native or repaired right ventricular outflow tract.

4. Subject has been recommended for surgical pulmonary valve replacement by treatingclinical team (cardiologist and cardiac surgeon).

5. Subject has at least one of the following echocardiographic findings:

6. Severe pulmonary stenosis (defined as RV to PA peak instantaneous gradient ≥60mmHg);

7. Moderate or greater pulmonary regurgitation;

8. Moderate or greater pulmonary stenosis plus moderate or greater pulmonaryregurgitation.

9. Subject's body size is suitable for implantation of a study device ranging from 12.7to 22 mm (internal diameter).

10. Subject and parent/legal representative, where appropriate, are willing to provideinformed written consent.

11. Subject and parent/legal representative, where appropriate, and treating physicianagree that the subject will return for, and comply with, all required studyassessments and follow-up visits.

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions are met:

1. Subject requires valve replacement in a non-pulmonary position.

2. Subject has a prosthetic valve at other valve position or will need a prostheticvalve at other valve position (i.e., anticipate additional valve replacements neededwithin 3 years).

3. Subject has pulmonary arterial hypertension (defined as mean PA pressure ≥25 mmHg).

4. Subject has pulmonary atresia and major aortopulmonary collaterals.

5. Subject has significant peripheral pulmonary artery stenosis.

6. Subject has an active infection requiring current systemic antibiotic therapy (iftemporary illness, subject may be a candidate 4 weeks after discontinuation ofantibiotics).

7. Subject has active endocarditis or a history of infective endocarditis.

8. Subject has renal insufficiency as determined by a serum creatinine (S-Cr) level ≥2.5 mg/dL within 60 days prior to the Screening Visit, or has end-stage renaldisease.

9. Subject has leukopenia (defined as a white blood cell (WBC) count <3.5 x 103/µL)

10. Subject has acute or chronic anemia (defined as hemoglobin (Hgb) <10.0 g/dl or 6mmol/L).

11. Subject has thrombocytopenia (defined as platelet count <50 x 103/µL.

12. Subject has a known hypersensitivity to anticoagulants and antiplatelet drugs.

13. Subject has a known autoimmune disease or receives immunosuppressant and/orimmunostimulant drugs that the Investigator or Eligibility Screening Committee (ESC)believes may negatively affect study outcomes.

14. Subject needs emergency cardiac or vascular surgery or intervention.

15. Positive pregnancy test prior to valve implant procedure in female subjects who havehad their first menses.

16. Subject has, in the opinion of the Investigator, a life expectancy of less than 5years.

17. Subject or parent/legal representative refuses blood transfusions.

18. Subject has medical, social or psychosocial factors that, in the opinion of theInvestigator or ESC, could impact safety or compliance with study procedures.

19. Subject is participating in an investigational study of a new drug, biologic ordevice at the time of study screening.