13.1 Inclusion Criteria

Patients must meet all of the following criteria to be considered for inclusion in this clinical

investigation:

1. 21 years of age or older.

2. Presence of severe degenerative mitral regurgitation with isolated mid-segment

posterior leaflet prolapse by echocardiographic study.

3. Mitral leaflet coaptation surface sufficient to reduce mitral regurgitation without

undue leaflet tension, based on the judgment of the Echocardiographic Core Lab.

4. Competent to sign informed consent and able to return for follow-up and is

capable of participating in all testing associated with this clinical investigation.

13.2 Exclusion Criteria

Patients will be excluded if any of the following criteria apply:

1. Functional mitral regurgitation (FMR).

2. Evidence of anterior or bileaflet prolapse.

3. Severe mitral annular calcification (MAC).

4. Moderate or greater leaflet calcification.

5. Fragile or thinning apex (e.g. LV aneurysm).

6. Have undergone cardiac or peripheral vascular procedures within 30 days prior to

the trial procedure.

7. Planned cardiac or peripheral vascular procedures within 30 days after the trial

procedure.

8. Requirement for concomitant cardiac surgery.

9. Severe pulmonary hypertension (pulmonary artery systolic pressure > 60mmHg).

10. Severe aortic stenosis or insufficiency.

11. Severe tricuspid regurgitation. (Patients with mild or moderate tricuspid

regurgitation are not excluded.)

12. Left or right ventricular ejection fraction (LVEF or RVEF) <30% as measured by the

core lab.

13. Any history of endocarditis.

14. Contraindication to cardiac surgery, including hostile chest or history of

mediastinal radiation.

15. Previous structural heart intervention (e.g. any heart valve replacement or repair

procedures) with the exceptions of coronary artery bypass grafting (CABG) or

percutaneous coronary intervention (PCI).

16. Stroke within 30 days prior to index procedure.

17. ST segment elevation myocardial infarction (STEMI) requiring intervention within

30 days prior to index procedure.

18. Evidence of cirrhosis or hepatic synthetic failure (Child-Pugh Class B or higher, [or

MELD score of ≥ 13]).

20. Hemodynamic instability or cardiogenic shock at the time of enrollment (e.g.

requiring inotropic support or mechanical support devices).

21. History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3000 mcL) or

acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL).

22. Refuse blood products.

23. Planned treatment with any other investigational device or procedure through 1-

year follow-up, or who are currently participating in an investigational drug or

device trial.

24. Carotid stenosis ≥ to 80% at time of enrollment.

25. Rheumatic heart disease including rheumatic mitral stenosis.

26. Pregnant or lactating at the time of enrollment (women of childbearing age

should have negative pregnancy test within 72 hours of surgery) or planning

pregnancy within the next 12 months.

27. Concurrent medical condition with a life expectancy of less than 12 months in the

judgment of the Investigator.

28. Condition or conditions that, in the opinion of the Investigator, precludes

participation, including willingness to comply with all follow-up procedures.

29. Contraindication for transesophageal echocardiography (TEE), including

esophageal spasm, esophageal stricture, esophageal laceration, esophageal

perforation, esophageal diverticula (e.g. Zenker's diverticulum).

30. Echocardiographic evidence of intracardiac mass (e.g. left ventricular, atrial, or

appendage thrombus, myxoma, or vegetation).

31. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet

regimen.

Intra-operative exclusion criteria

32. No longer meets eligibility criteria based on intra-operative assessment.

19. Renal insufficiency CKD Stage 3b or worse (GFR < 45 ml/min/1.73 m2).