INSPIRIS RESILIA Valve in Pulmonary Position

Inclusion Criteria:

1. pulmonary valve disease requiring pulmonary valve replacement of their native orprosthetic valve, equal to or greater than five years of age.
2. Patients and/or patient´s legal representatives must provide written informed consentas approved and required by the respective institutional review board and agree to itsprovisions.
3. The patient has completed all preoperative investigations.

Exclusion Criteria:

1. Requires emergency surgery
2. Has acute myocardial infarction (MI) within 30 days prior to screening date
3. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transientischemic attack (TIA) within six months prior to screening date
4. Has hemodynamic or respiratory instability requiring inotropic support, mechanicalcirculatory support, or mechanical ventilation within 30 days prior to screening date
5. Has active endocarditis/myocarditis or endocarditis/myocarditis within three monthsprior to screening date
6. Has renal insufficiency as determined by creatinine level ≥ 2.5 mg/dL within 60 daysprior to screening visit or end-stage renal disease
7. Has documented:
8. leukopenia (WBC < 3.5x 103/µL),
9. acute anemia (Hgb<10.0 g/dL or 6 mmol/L), or
10. thrombocytopenia (platelet count < 50x 103/µL) accompanied by history of bleedingdiathesis or coagulopathy within 60 days prior screening date
11. Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism 10.Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation 11. RVOTaneurysm unless treated during pulmonary valve replacement surgery 12. Has prior organtransplant or is currently an organ transplant candidate 13. Was previously implanted withstudy trial device 14. Previously implanted with an aortic, mitral, or tricuspidbioprosthetic valve or mechanical valve 16. Has presence of non-cardiac disease limitinglife expectancy to less than 12 months 17. Is currently or has recently participated (within six weeks) in another investigational drug or device trial 18. Positive urine orserum pregnancy test in female subjects of child-bearing potential and/or nursing mothers
12. Currently incarcerated or unable to give voluntary informed consent 21. Documentedhistory of substance (drug or alcohol) abuse within the last five years prior to screeningdate