This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification. Subjects satisfying the study criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.
CRITERIA LIST/ QUALIFICATIONS:
Severe, symptomatic mitral regurgitation
NYHA ≥ II (if Class IV, patient must be ambulatory)
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