INSPIRIS RESILIA Valve in Pulmonary Position

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 transient ischemic attack (TIA) within six months prior to screening date
• •4. Has hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to screening date
• •5. Has active endocarditis/myocarditis or endocarditis/myocarditis within three months prior to screening date
• •6. Has renal insufficiency as determined by creatinine level ≥ 2.5 mg/dL within 60 days prior to screening visit or end-stage renal disease
• •7. Has documented:
• •1. leukopenia (WBC \< 3.5x 103/µL),
• •2. acute anemia (Hgb\<10.0 g/dL or 6 mmol/L), or
• •3. thrombocytopenia (platelet count \< 50x 103/µL) accompanied by history of bleeding diathesis or coagulopathy within 60 days prior screening date
• •9\. Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism 10. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation 11. RVOT aneurysm unless treated during pulmonary valve replacement surgery 12. Has prior organ transplant or is currently an organ transplant candidate 13. Was previously implanted with study trial device 14. Previously implanted with an aortic, mitral, or tricuspid bioprosthetic valve or mechanical valve 16. Has presence of non-cardiac disease limiting life 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 or serum pregnancy test in female subjects of child-bearing potential and/or nursing mothers 20. Currently incarcerated or unable to give voluntary informed consent 21. Documented history of substance (drug or alcohol) abuse within the last five years prior to screening date