Mitroflow DL Post Approval Study- North America

The purpose of this clinical investigation is to evaluate the safety and efficacy of the
Mitroflow DL valve when used to replace diseased or dysfunctional native or prosthetic aortic
heart valves. The study will be conducted in a minimum of 15 centers in the United States.
Patients will be evaluated at each of the following time intervals:preoperative, at implant,
in the early postoperative period, at 1 year (between 11 and 13 months postoperatively), and
annually for 8 years. The duration of the study is anticipated to be 8 years.

Inclusion Criteria:

1. Patients is indicated for Mitroflow DL implantation according to the Instructions for
Use (IFU).

2. Patient or patient's legal representative is willing to sign the informed consent.

3. Patient's preoperative evaluation indicated the need for native or prosthetic aortic
valve replacement

4. Any patient amenable to aortic valve replacement with a biological prosthesis should
be enrolled in the study, even in conjuction with valve repair, coronary artery bypass
grafting and other procedures

5. Patient is able to return for all follow-up evaluations for the duration of the study
(geographically stable).

Exclusion Criteria:

1. Patient is contra-indicated for Mitroflow DL implantation according to the
Instructions for Use.

2. The patient has a pre-existing valve prosthesis in the mitral, pulmonary, or tricsupid
position.

3. Patient requires a double or triple valve replacement (repair is not considered an
exclusion).

4. Patient has active endocarditis or myocarditis.

5. Patient is pregnant or lactating.

6. Patient is participating in a concomitant research study of an investigational
product.