Freedom SOLO Stentless Heart Valve Study

The SOLO clinical investigation is a prospective, non-randomized, multicenter trial of the
SOLO Freedom heart valve implanted in patients requiring aortic valve replacement.

Inclusion Criteria:

- The subject is male or female 18 years old or older.

- The subject or subject's legal representative is willing to sign the informed
consent.

- The subject which preoperative evaluation indicated the need for native or prosthetic
aortic valve replacement.

- Any subject amenable to aortic valve replacement with biological prosthesis should be
enrolled in the study, even in conjunction with valve repair, coronary artery bypass
grafting and other procedures.

- The subject is located in a geographic location that will enable the subject to
return to the study site for all follow-up examinations (i.e. geographically stable).

- Subject will be available to the investigator(s) for postoperative follow-up beyond
one year.

Exclusion Criteria:

- The subject has preexisting valve prosthesis in the mitral, pulmonary or tricuspid
position.

- The subject requires a double or multiple valve replacement (a valve repair is not
considered an exclusion criterion).

- The subject has a previously implanted SOLO valve, within the clinical study, that
requires replacement.

- The subject has active endocarditis or myocarditis.

- The subject is or will be participating in a concomitant research study of an
investigational product.

- The subject is a minor, drug abuser, alcohol abuser, prison inmate,
institutionalized, or is unable to give informed consent.

- The subject has a major or progressive non-cardiac disease that, in the
investigator's experience, results in a life expectancy of less than 1 year, or the
implant of the device produces an unacceptable increased risk to the subject.

- The subject is pregnant, planning to become pregnant or lactating.

- The subject has a congenital bicuspid aortic valve.

- The subject is known to be noncompliant or is unlikely to complete the study.

- The subject is undergoing renal dialysis for chronic renal failure or has been
diagnosed with hyperparathyroidism.

- The subject has had an acute preoperative neurological deficit, myocardial
infarction, or cardiac event that has not returned to baseline or stabilized ≥30 days
prior to the planned valve implant surgery.

- The subject has extensive calcification of the aortic root where removal of the
calcified tissue cannot be achieved.

- The subject has a significantly dilated aortic root that is not surgically corrected.

- The subject requires replacement of the aortic root / full root procedure.