Magna Mitral - 23mm

This is a prospective, non-randomized, multi-site, descriptive study. A minimum of 15 and up
to 20 subjects will be implanted at a minimum of 2 and up to 8 participating investigational
sites within the US and internationally.

Inclusion Criteria:

1. Patient has mitral valve disease requiring surgical replacement

2. Patient has provided written informed consent prior to mitral valve surgery

3. Patient is expected to survive surgery and be discharged

4. Patient is willing to comply with specified follow-up evaluations

5. Patient is 13 years of age or older

Exclusion Criteria:

1. Patient has life expectancy < 12 months due to non-cardiac co-morbid conditions;

2. Patient has/had active endocarditis within the last 3 months

3. Patient requires replacement of a native or previously implanted prosthetic,
tricuspid, pulmonic or aortic valve;

4. Patient was previously enrolled and implanted in the study

5. Patient has/had prior aortic, tricuspid and/ or pulmonary valve surgery, which
included implantation of a bioprosthetic valve or mechanical valve that will remain in
situ

6. Patient has a body surface area (BSA) > 1.9m2

7. Female patients who are pregnant, planning to become pregnant, or lactating

8. Patient has a documented history of substance ( drug or alcohol) abuse

9. Patient is currently a prison inmate

10. Patient is currently participating in an investigational drug or another device study

11. Patient is undergoing renal dialysis for chronic renal failure or has
hyperparathyroidism

12. Patient has active myocarditis

13. Patient has had an acute preoperative neurological deficit, myocardial infarction, or
cardiac event and has not returned to baseline or stabilized > 30 days prior to the
planned v alve implant surgery

14. Patient has an abnormality such as an aortic aneurysm (e.g. due to cystic medial
necrosis or Marfan's syndrome), aortic dissection, or ventricular aneurysm that might
place