COMMENCE Pulmonary: Clinical Evaluation of Edwards Pericardial Aortic Bioprosthesis (Model 11000A) for Pulmonary Valve Replacement

This is a prospective, Non-Randomized, Single Arm, Multicenter study. Up to one hundred (100)
pulmonary valve replacement (PVR) subjects at up to ten (10) clinical sites will be enrolled
to assess the safety and effectiveness of the Edwards Peri-cardial Aortic Bioprosthesis Model
11000A in the pulmonary position. The trial will include male and female subjects five year
and older requiring pulmonary valve replacement of their native or prosthetic valve. Subjects
will be followed for and assessed after implant for up to 5 years.

Inclusion Criteria:

1. Has pulmonary valve disease requiring pulmonary valve replacement of their native or
prosthetic valve

2. Is greater than or equal to 5 years of age

3. Subject and/or subject's legal representative has provided written informed consent

Exclusion criteria:

A subject meeting any of the following criteria shall be excluded:

1. Requires valve-in-conduit procedure

2. Requires emergency surgery

3. Has acute myocardial infarction (MI) within 30 days prior to screening date

4. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient
ischemic attack (TIA) within 6 months (180 days) prior to screening date

5. Has hemodynamic or respiratory instability requiring inotropic support, mechanical
circulatory support, or mechanical ventilation within 30 days prior to screening date

6. Has active endocarditis/myocarditis or endocarditis/myocarditis within 3 months prior
to screening date

7. Has renal insufficiency as determined by creatinine (S-Cr) level ~ 2.5 mg/dL within 60
days prior to screening visit or end-stage renal disease

8. Has documented leukopenia (WBC < 3.5x 103/I-lL), acute anemia (Hgb <10.0 g/dL or 6
mmol/L), or thrombocytopenia (platelet count < 50xl03/I-lL) accompanied by history of
bleeding diathesis or coagulopathy within 60 days prior to 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,
mechanical valve

15. Need for concomitant replacement of the aortic, mitral or tricuspid valves or
annuloplasty ring that will remain in situ

16. Has presence of non-cardiac disease limiting life expectancy to less than 12 months

17. Is Currently or has recently participated (within 6 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

19. Has left ventricular ejection fraction ≤20% as validated by diagnostic procedure prior
to screening date or planning to become pregnant during the participation in the trial

20. Currently incarcerated or unable to give voluntary informed consent

21. Documented history of substance (drug or alcohol) abuse within the last 5 years prior
to screening date

Intra-Op Exclusion Criterion:

22. Significant injury to the heart upon entry