PERIGON Pivotal Trial

This is a prospective, interventional, non-randomized, worldwide, multi-center trial, with
each site following a common protocol. A maximum of 1300 subjects will be implanted at a
maximum of 40 sites in the US, Europe and Canada. The trial will include male and female
patients of legal age to provide informed consent in the country where they enroll in the
trial, requiring replacement for a diseased, damaged, or malfunctioning native or prosthetic
aortic valve. Patients will be followed and assessed after implant for up to 5 years.

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