Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve

This is a prospective, non-randomized, multi-center trial. Up to 950 subjects will be
enrolled at up to 35 centers in the US. After replacement of their aortic heart valve with
the EDWARDS INTUITY valve system, each patient will have routine follow-up tests at the
following intervals: discharge, 3 months, 1 year, and annually thereafter for a minimum of
five years.

Inclusion Criteria:

- Inclusion Criteria - Subjects will be required to meet all inclusion criteria:

1. Male or female, age 18 years or older

2. Has aortic stenosis or stenosis-insufficiency of an aortic valve requiring a
planned replace-ment as indicated in the preoperative evaluation

3. Is scheduled to undergo planned aortic valve replacement with or without
concomitant coronary bypass surgery

4. Provide written informed consent

5. Geographically stable and agrees to attend follow-up assessments until all
subjects have completed 5 years of follow up

Exclusion Criteria:

- Exclusion Criteria - Subjects will not be eligible for trial participation if any of
the following criteria are present:

1. Pure aortic insufficiency

2. Requires emergency surgery

3. Previous aortic valve replacement

4. Had prior mitral, tricuspid or pulmonic valve surgery, which included implant of
a bioprosthetic valve, mechanical valve, or annuloplasty ring that will remain in
situ

5. Requires multiple valve replacement/repair

6. Requires a surgical procedure outside of the cardiac area (e.g., vascular
endarterectomy, vascular bypass, tumor removal)

7. Aneurysm of the aortic root and/or ascending aorta requiring surgical
intervention

8. Active endocarditis/myocarditis or endocarditis/ myocarditis within 3 months
prior to the scheduled AVR surgery

9. Myocardial infarction (MI) within thirty (30) days prior to valve replacement
surgery

10. Renal insufficiency as determined by creatinine ≥ 2.5 mg/dL at screening or
end-stage renal disease requiring chronic dialysis

11. Hyperparathyroidism

12. MRI or CT-scan confirmed cerebrovascular accident (CVA), or transient ischemic
attack (TIA) within 6 months (180 days) of the procedure

13. Presence of non-cardiac disease limiting life expectancy to less than 12 months

14. Hypertrophic obstructive cardiomyopathy (HOCM)

15. Left ventricular ejection fraction ≤ 25%

16. Documented history of substance (drug or alcohol) abuse within the last 5 years

17. Echocardiographic evidence of an intra-cardiac mass, thrombus, or vegetation

18. Hemodynamic or respiratory instability requiring inotropic support, mechanical
circulatory support, or mechanical ventilation within 30 days prior to the
procedure

19. Pregnancy, lactation, or planning to become pregnant;

20. Currently incarcerated or unable to give voluntary informed consent

21. Leucopenia (WBC < 3.5x 103/µL), or acute anemia (Hgb < 10.0 gm/dL or 6 mmol/L),
or thrombocytopenia (platelet count < 50x 103/µL), or history of bleeding
diathesis or coagulopathy

22. History of myxomatous disease/connective tissue disorders (e.g., Marfan's
Syndrome)

23. Current or recent participation (within 6 weeks prior to surgery) in an
investigational drug or device trial

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Intra-operative Exclusion Criteria

24. Anatomic variances which contraindicate implant of the trial valve, such as:

1. anomalous coronary arteries

2. annular deformation or extensive calcification of the annulus or aortic root
which cannot be removed

3. significant calcium on the anterior mitral leaflet

4. pronounced septal calcification

5. position of coronary ostia relative to Model 8300ACD valve that would result
in obstruction of blood flow

25. Available devices are not suitably sized for the subject's annulus