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The Carpentier-Edwards Physio annuloplasty ring is intended for the correction of mitral valve insufficiency, or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve.

The Carpentier-Edwards Physio annuloplasty ring, Model 4450 is constructed of Elgiloy bands separated by polyester film strips and has a sewing ring margin that consists of a layer of silicone rubber covered with a woven polyester cloth.

The mitral annuloplasty ring conforms to the configuration of a normal mitral annulus. It is kidney-shaped with one long curved segment corresponding to the posterior leaflet annulus. A rectilinear portion corresponds to the anterior leaflet annulus. Transverse colored threads indicate the anterior and posterior commissures.

The ring exhibits characteristics of differential flexibility. While retaining stiffness, the annuloplasty ring is also flexible in the portion corresponding to the anterior leaflet. The flexibility is increased in the posterior regions of the ring. Along the annular plane the ring is stable with a saddle-shaped curve for apposition to the aortic root.

The design is intended to provide support after annuloplasty surgery. The ring maintains a fixed maximum annular dimension to prevent excessive distension of the natural valve annulus while adapting to the dynamic motion of the mitral annulus throughout the cardiac cycle.

The holder, designed to facilitate ring implantation, is manufactured from an amorphous polymer. The annuloplasty ring is mounted on the holder with three retaining sutures.

The handle, Model 1150, may be utilized in conjunction with the holder to facilitate ease of suture placement and implantation. The middle section of the handle is malleable, allowing the handle to be adjusted (bent) in a configuration convenient for use. The handle is packaged separately. The snap assembly of the handle and holder allows for connecting and disconnecting the two components at appropriate times during the surgical procedure.

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