Feasibility of a Mitral Annuloplasty With the Capability for Peri- and Postoperative Adjustment

Abstract

Surgical repair with implantation of a mitral annuloplasty ring is the gold standard treatment for mitral regurgitation. However, outcomes are variable and recurrent mitral regurgitation is not uncommon. A REshapeable Mitral Annuloplasty DevIce (REMADI) is proposed, which consists of a fully encapsulated low melting temperature alloy. The alloy is solid and rigid at body temperature and provides traction force to shape the annulus. When heated using a noncontact method, the alloy melts and the REMADI becomes malleable. The REMADI is engaged with the mitral valve annulus using anchors which automatically deploy upon contact. A passive beating porcine heart model was used to demonstrate the feasibility of the REMADI device, which was deployed, engaged, and used to reduce the diameter of the mitral valve annulus.