Aortic or Mitral Valve Replacement With the Biocor and Biocor Supra

The clinical investigation is a multi-center, prospective, non-randomized, observational,
FDA-required post-approval study designed to further evaluate the safety and effectiveness of
the Biocor and Biocor Supra Valves.

Inclusion Criteria:

- Requires aortic or mitral valve replacement (heart surgery such as bypass is allowed
at the same time)

- Legal age

- Signed informed consent prior to surgery

- Willing to complete all follow-up requirements

Exclusion Criteria:

- Pregnant or nursing women

- Already have had a valve replaced other than that for the scheduled replacement

- Needs another valve replaced

- Cannot return for required follow-up visits

- Have active endocarditis

- Acute preoperative neurological event (such as a stroke)

- Renal dialysis

- History of substance abuse within one year or is a prison inmate

- Participating in another study

- Had the Biocor or Biocor Supra valve implanted but then the device was explanted

- Life expectancy less than five years