CorMatrix Cor TRICUSPID ECM Valve Replacement Study

CorMatrix Cardiovascular, Inc. has developed a device for heart valve replacement, the
CorMatrix® Cor ECM® Tricuspid Valve, which can be implanted to replace dysfunctional
tricuspid heart valves. This Early Feasibility Study is proposed to obtain initial insights
into the ability to successfully implant the Tricuspid Valve, the clinical safety of the
device, and whether the device performs its intended use. The study is a multi-center,
prospective, single-arm, Early Feasibility Study (EFS) of subjects receiving the Cor
TRICUSPID ECM Valve or Cor PEDIATRIC Tricuspid ECM Valve. The study will be conducted at up
to 8 sites.

Up to 15 subjects will undergo tricuspid valve replacement (TVR) with the CorMatrix ECM Valve
for the surgical management of tricuspid valve disease. The cohort will include up to 10
adult patients and up to 5 pediatric patients.

Inclusion Criteria:

1. Patient with a regurgitant or absent tricuspid valve requiring surgical treatment
including those patients having concomitant cardiac procedures

2. Male or female

3. Patient/authorized legal guardian understands the nature of the procedure, is willing
to comply with associated follow-up evaluations, and provides written informed consent
and the pediatric patient (if applicable) provides written assent (if able) prior to
procedure

4. Patient/patient's authorized legal guardian is geographically stable (or willing to
return for required study follow-up) and understands and is willing to fulfill all of
the expected requirements of this clinical protocol

5. Children with congenital disease where the Cor PEDIATRIC Tricuspid ECM Valve would be
the physiological right-sided valve

Exclusion Criteria:

1. Tricuspid annulus too small (< 10mm) to accommodate the Cor Tricuspid ECM Valve

2. Left ventricular ejection fraction (LVEF) < 25%

3. Mean pulmonary pressure > 50mm Hg or pulmonary vascular resistance greater than 6
Woods Units

4. Emergency cardiac procedure. An example would be a person requiring resuscitation and
in cardiogenic shock. An unscheduled or unplanned emergency surgery

5. Cardiac transplant patient

6. Acute transmural myocardial infarction (MI) within 7 days of enrollment that results
in cardiogenic shock

7. Patients with a single ventricle where the Cor Tricuspid ECM Valve would be the
systemic AV valve

8. Documented primary coagulopathy or uncorrected platelet disorder, including
thrombocytopenia (absolute platelet count <30k). Patient can be enrolled regardless of
these parameters if in the opinion of the Investigating Surgeon the coagulopathy can
be adequately reversed by transfusions. An example would be the reversal of
thrombocytopenia by transfusion of platelets

9. Documented evidence of intrinsic hepatic disease (defined as liver enzyme values
(aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin)
that are > 5 times the upper limit of reference range within 30 days of enrollment,
except in association with acute/reversible decompensation as determined by the
Investigator)

10. Documented evidence of significant renal dysfunction (serum creatinine > 4.0mg/dl or
GFR< 30 on the modified Schwartz formula)

11. Stroke within 30 days prior to enrollment

12. Major or progressive non-cardiac disease (liver failure, renal failure, cancer (CA))
that has a life expectancy of less than one year

13. Known cancer (cancer-free <1 year; does not include non-metastatic basal cell
carcinoma or cervical carcinoma) and/or undergoing treatment including chemotherapy
and radiotherapy

14. Hematological disorders (e.g., aplastic anemia) or patients taking bone marrow
suppressant drugs

15. Known sensitivity to porcine materials

16. Contraindication to anticoagulation/antiplatelet therapy (aspirin (ASA) and/or Plavix)

17. Patients who are pregnant (method of assessment Investigator's discretion)

18. Patients who are currently enrolled in another investigational study or registry that
would directly impact the treatment or outcome of the current study, without CorMatrix
written approval