A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)

A Clinical Study of the CardiAQ™ Transcatheter Mitral Valve Implantation (TMVI) System (Transapical Delivery System)

The purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System.

The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.

Key Inclusion Criteria:

• NYHA Classification ≥ III
• Left Ventricular Ejection Fraction ≥ 30%
• Mitral regurgitation ≥ Grade 3+
• Subject meets anatomical eligibility criteria for the investigational device