AMEND TS Early Feasibility Study

Inclusion Criteria:

1. Patient age >21

2. The patient will benefit from isolated mitral valve annuloplasty for mitralregurgitation without the need for concomitant cardiovascular surgical proceduressuch as coronary artery bypass or another valve reconstruction or replacement

3. Symptomatic functional MR≥3+

4. NYHA functional capacity ≥2

5. LV Ejection Fraction > 30%, LVEDD < 68 mm

6. The subject meets the anatomical eligibility criteria for available implant size(s)

7. The subject is at high risk for mitral valve surgery as assessed by the center'sheart team for mitral procedures.

8. The subject has been stable and on a stable pharmacological regimen for heartfailure for at least 1 month prior to inclusion

9. Femoral vein access and transseptal device access is determined to be feasible bythe implanting investigator

10. The patient is willing to comply with study procedures and is available to return tothe implant center for follow-up visits

11. Informed consent documentation signed and dated confirming that the patient has beenadequately informed of all aspects related to his/her participation in the clinicalstudy and is willing to participate.

Exclusion Criteria:

1. The patient has mitral incompetence where an annuloplasty ring will not contributeto its repair

2. Cardiac or non-cardiac major or progressive disease, which in the investigator'sdiscretion produces an unacceptable increased risk to the patient.

3. Life expectancy of less than 12 months

4. The subject is non-operable and is not eligible for TEER, to allow bailout

5. Heavily calcified mitral annulus or leaflets

6. Previous or active endocarditis.

7. Active infection

8. A previously implanted prosthetic aortic valve or mitral intervention

9. Cardiovascular intervention within 30 days prior to study procedure

10. GFR <30 ml/min

11. The patient has had an ischemic coronary event within 30 days prior to studyprocedure

12. The patient has clinically significant coronary artery disease requiring re-vascularization

13. The subject is contraindicated to general anesthesia

14. The subject is unable to take anti-platelet or anti-coagulant medications

15. A known allergy to nickel

16. Severe allergy to contrast media

17. Significant right ventricle dysfunction

18. Left atrial thrombus

19. A cerebral vascular event (CVA or TIA) within the past 12 months

20. A mitral valve anatomy which may preclude proper AMEND™ treatment

21. Pulmonary systolic hypertension (estimated SPAP > 70 mmHg at rest), determined byechocardiography

22. Pregnant (for women in the reproductive age, blood HCG test result positive) orlactating patient

23. Drug or alcohol abuse

24. Participation in concomitant research studies of investigational products

25. Any planned cardiac surgery or interventions within the next 7 months

26. Implant or revision of any rhythm management device (cardiac resynchronizationtherapy (CRT) or cardiac resynchronization therapy device (CRT-D)) or implantablecardioverter defibrillator within the prior month

27. Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support ormechanical hemodynamic support

28. Status 1 heart transplantation or prior orthotopic heart transplantation

29. Subjects in whom transesophageal echocardiography is contraindicated or high risk