MASA Valve Early Feasibility Study

Eligibility Criteria

• 1. At least one of the following: Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis.
• 2. Age \< 22 years
• 3. Patient is geographically stable and willing to return for 1 year follow-up for the trial.
• 4. Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.
• 5. The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.
• 1. Patient is in need of or has presence of a prosthetic heart valve at any other position
• 2. Patient has a need for concomitant surgical procedures (non-cardiac)
• 3. Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
• 4. Patient has an active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
• 5. Patient has an active endocarditis
• 6. Leukopenia, according to local laboratory evaluation of white blood cell count
• 7. Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
• 8. Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria
• 9. Severe chest wall deformity, which would preclude placement of the PV conduit
• 10. Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
• 11. Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
• 12. Patient has chronic inflammatory / autoimmune disease
• 13. Need for emergency cardiac or vascular surgery or intervention
• 14. Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
• 15. Currently participating, or participated within the last 30 days, in an investigational drug or device study
• 16. Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months
• 17. Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance