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MEMO 3D™ device is intended for correction of mitral insufficiencies or stenoinsufficiencies. The use of the MEMO 3D™ device is indicated for correction of congenital or acquired mitral insufficiencies with dilatation and deformation of the mitral annulus. Type I insufficiencies, with no manifest lesions in the subvalvular apparatus, can be treated with the device on its own. For type II insufficiencies, characterized by valve prolapse sustained by elongation/breakage of the chordae tendineae and papillary muscles, and type III insufficiencies, characterized by partially immobilized leaflets due to the fusion/hypertrophy of the chordae tendineae. the device implantation must be accompanied by corrective valvuloplasty.

The MEMO 3D™ Semirigid Annuloplasty Ring is supplied as a sterile, non- pyrogenic, non-ferromagnetic ring pre-mounted on a disposable holder. The annuloplasty ring is manufactured by embedding a metallic inner core with medical grade silicone. The resulting silicone sheath, around the metallic core, is then encased within a tubular knitted fabric coated with Carbofilm™, which is a thin layer of turbostratic carbon. The fabric is then sewn along its length with Carbofilm™ coated polyester thread. The annuloplasty ring is attached to the disposable holder to maintain the shape of the ring during implantation and allow for measured plications of the mitral annulus. Suture guides are present on the holder to aid the surgeon during ring placement. The MEMO 3D™ annuloplasty ring is available in sizes 24mm through 38mm in two millimeter increments. A complete set of accessory instrumentation is to be available separately to properly size the annulus and implant the annuloplasty ring.