Device Dossier
Memo 4D Annuloplasty Ring - Mitral/tricuspid annuloplasty ring
Device Dossier for Memo 4D Annuloplasty Ring - Mitral/tricuspid annuloplasty ring (Mitral/tricuspid annuloplasty ring, Class III, sponsor BTC Cardio).…
- GMDN category: Mitral/tricuspid annuloplasty ring
Intended purpose
Memo 4D device is intended for correction of mitral insufficiencies or steno-insufficiencies. The use of the Memo 4D device is indicated for correction of congenital or acquired mitral insufficiencies with dilatation and deformation of the mitral annulus.
Functional description
The Memo 4D consists of a Nickel - Titanium alloy inner core enclosed in a sewing ring of silicone and knitted polyester fabric. The fabric is coated with Carbofilm™, a thin layer of turbostratic carbon. The ring exhibits flexibility to accommodate the three-dimensional annulus motion. To support the remodeling, the flexibility is maximal in the posterior curved portion and gradually decreases towards the anterior linear segment