AMENDTM Mitral Valve Repair System, Annuloplasty Ring Applied in a Transcatheter Method

AMEND I Study - for the Valcare Medical AMEND TM Mitral Valve Repair System

A multi center study to evaluate the safety of the AMENDTM Mitral Valve Repair System and its ability to reduce mitral regurgitation. AMEND device is an annuloplasty ring implanted in a minimally invasive trans-catheter method.

Inclusion Criteria:

• Patient age ≥18
• The patient requires mitral valve annuloplasty for mitral regurgitation without the need for concomitant cardiovascular surgical procedures
• NYHA functional capacity ≥2
• The subject is high risk to undergo a mitral valve surgery as assessed by the center heart team
• The patient is willing to comply with study procedures and is available to return to the implant center for follow-up visits.
• The patient is willing to provide Informed consent

Exclusion Criteria:

• Cardiac or non-cardiac major or progressive disease, which in the investigator's discretion produces an unacceptable increased risk to the patient.
• Life expectancy of less than twelve months.
• Heavily calcified annulus or leaflets.
• Previous or active endocarditis.
• Active infection.
• A previously implanted prosthetic mitral valve or annuloplasty ring/band.
• The patient is contraindicated to general anesthesia.
• Pregnant (urine HCG test result positive) or lactating patient.
• Drug or alcohol abuse.
• Participation in concomitant research studies of investigational products that will interfere with the study.