AMEND TS Early Feasibility Study

Objective: The purpose of this clinical investigation, the AMEND TS Early Feasibility Study, is to evaluate the safety and functionality of the AMEND Trans-Septal System for annuloplasty as treatment of mitral regurgitation. Device Description: The AMENDTM Trans-Septal System consists of a semi-rigid annuloplasty ring (implant), a delivery system (catheter), and accessories (Stage, Introducer sheath). The device is delivered through a catheter using a trans-septal approach and implanted in the beating heart on the atrial surface of the mitral valve annulus similar to surgical annuloplasty rings. Indications for Use: The device is indicated to treat patients with mitral regurgitation using a percutaneous direct annuloplasty approach Number of subjects and sites: Up to fifteen (15) subjects will be enrolled to the study procedure in up to 7 investigational centers in the U.S. and Canada Study Population: Subjects with symptomatic moderate-to-severe (3+) or severe (4+) functional mitral regurgitation that is anatomically amenable to transcatheter mitral annuloplasty. Study Duration: 5 years