PERIGON Pivotal Trial

Inclusion Criteria:

   1. Patient has moderate or greater aortic stenosis or regurgitation, and there is
   clinical indication for replacement of their native or prosthetic aortic valve with a
   bioprosthesis, with or without concomitant procedures, which are limited to any of the
   following:

   i. LAA ligation ii. CABG iii. PFO closure iv. Ascending aortic aneurysm or dissection
   repair not requiring circulatory arrest v. Resection of a sub-aortic membrane not
   requiring myectomy

   2. Patient is geographically stable and willing to return to the implanting site for all
   follow-up visits

   3. Patient is of legal age to provide informed consent in the country where they enroll
   in the trial

   4. Patient has been adequately informed of risks and requirements of the trial and is
   willing and able to provide informed consent for participation in the clinical trial

Exclusion Criteria:

   1. Patient has a pre-existing prosthetic valve or annuloplasty device in another position
   or requires replacement or repair of the mitral, pulmonary or tricuspid valve

   2. Patient has had previous implant and then explant of the Model 400 aortic valve
   bioprosthesis

   3. Patient presents with active endocarditis, active myocarditis or other systemic
   infection

   4. Patient has an anatomical abnormality which would increase surgical risk of morbidity
   or mortality, including:

      - Ascending aortic aneurysm or dissection repair requiring circulatory arrest

      - Acute Type A aortic dissection

      - Ventricular aneurysm

      - Porcelain aorta

      - Hostile mediastinum

      - Hypertrophic obstructive cardiomyopathy (HOCM)

      - Documented pulmonary hypertension (systolic >60mmHg)

   5. Patient has a non-cardiac major or progressive disease, with a life expectancy of less
   than 2 years. These conditions include, but are not limited to:

      - Child-Pugh Class C liver disease

      - Terminal cancer

      - End-stage lung disease

   6. Patient has renal failure, defined as dialysis therapy or GFR<30 mL/min/1.73 m2

   7. Patient has hyperparathyroidism

   8. Patient is participating in another investigational device or drug trial or
   observational competitive study

   9. Patient is pregnant, lactating or planning to become pregnant during the trial period

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

11. Patient has greater than mild mitral valve regurgitation or greater than mild
   tricuspid valve regurgitation as assessed by echocardiography

12. Patient has systolic EF<20% as assessed by echocardiography

13. Patient has Grade IV Diastolic Dysfunction

14. Patient has documented bleeding diatheses

15. Patient has had an acute preoperative neurological deficit or myocardial infarction
   and has not returned to baseline or stabilized ≥30 days prior to enrollment

16. Patient requires emergency surgery