Feasibility Study of the Tendyne Mitral Valve System for Use in Subjects With Mitral Annular Calcification

Inclusion Criteria:

1. Heart Team determines subject is not a suitable candidate for conventional surgical
treatment due to degree of Mitral Annular Calcification (MAC) present and, the subject
will likely benefit from transcatheter valve implantation

2. Severe, symptomatic mitral regurgitation (as defined in the 2017 ACC expert Consensus
Decision Pathway on the Management of MR)

3. New York Heart Association (NYHA) Functional Classification ≥ II (if Class IV, patient
must be ambulatory)

4. Age 18 years or older at time of consent

5. Not a member of a vulnerable population per the investigator's judgment

6. The subject or the subject's legal representative has been informed of the nature of
the study and agrees to its provisions, including complying with study required
testing and follow-up visits, and has provided written informed consent

Exclusion Criteria:

1. Presence of Left Ventricle or Left Atrium thrombus

2. Subject has a chest condition that prevents transapical access

3. Left Ventricular Ejection Fraction (LVEF) less than 25% assessed by echocardiogram

4. Left Ventricular End Diastolic Dimension (LVEDD) > 7.0 cm

5. Severe mitral stenosis not amenable to balloon valvuloplasty or transcatheter therapy

6. Prior intervention with permanently implanted mitral device (e.g. MitraClip)

7. Mitral pathoanatomy and Left Ventricular Outflow tract (LVOT) anatomy deemed not
suitable for Tendyne mitral valve implantation

8. Any planned cardiac surgery or intervention that is 30 days prior and 30 days post
that is not concomitant with the Tendyne procedure

9. Cardiac resynchronization therapy (CRT) device or implantable pulse generator (IPG)
implanted within three months of planned implant procedure

10. Myocardial Infarction (MI) within 30 days prior to the planned implant procedure

11. Symptomatic, or ischemia-associated coronary artery disease (e.g., active ischemia)
amenable to revascularization and thus requiring stenting or Coronary Artery Bypass
Grafting (CABG)

12. Cerebrovascular accident (CVA) within six months prior to the planned implant
procedure

13. Unresolved severe symptomatic carotid stenosis (>70% by ultrasound)

14. Cardiogenic shock or hemodynamic instability requiring inotropes or mechanical support
devices within 1 month prior to planned implant procedure

15. Severe tricuspid regurgitation or severe right ventricular dysfunction

16. Hypertrophic or restrictive cardiomyopathy, constrictive pericarditis or any other
structural heart disease causing heart failure other than dilated cardiomyopathy of
either ischemic or non-ischemic etiology

17. Any of the following: leukopenia, acute anemia, thrombocytopenia, history of bleeding
diathesis, or coagulopathy if cannot be adequately treated

18. History of endocarditis within 6 months of planned implant procedure

19. Active systemic infection requiring antibiotic therapy

20. Known hypersensitivity or contraindication to procedural or post-procedural
medications (e.g., contrast solution, anti-coagulation therapy) which cannot be
adequately managed medically

21. Subject unable or unwilling to take anticoagulation with warfarin for a minimum of 6
months following Tendyne valve implantation

22. Known hypersensitivity to nickel or titanium

23. Subject is undergoing hemodialysis due to chronic renal failure ( > Stage 4 Chronic
Kidney Disease (CKD))

24. Subject has pulmonary arterial hypertension (fixed PAS >70mmHg) Note: If PAS > 70mmHg,
site must provide documentation PAS is not fixed in order to be eligible

25. Forced Expiratory Volume during the first second (FEV1) < 50% of predicted or < 1L

26. Subject refuses blood transfusions

27. Subject has Chronic Obstructive Pulmonary Disease (COPD) requiring continuous home
oxygen therapy or chronic outpatient oral steroid use

28. Pregnant, lactating, or planning pregnancy within next 12 months Note: Female subjects
of childbearing age should be instructed to use safe contraception (e.g. intrauterine
devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches
hormonal vaginal devices, injections with prolonged release)

29. Currently participating in an investigational drug or another device trial that has
not reached its primary endpoint Note: Trials requiring extended follow-up for
products that were investigational, but have since become commercially available, are
not considered investigational trials

30. Subjects with non-cardiac co-morbidities that are likely to result in a life
expectancy of less than 12 months