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The Simplici-T™ Annuloplasty System is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis.

The Simplici-TTM Annuloplasty System is a single use, permanent, flexible, implantable device intended for the repair of a patient's mitral and tricuspid valves. The Simplici-T™ Annuloplasty Band is a 100 mm long band, constructed from a double velour polyester fabric wrapped around a small radiopaque silicone marker strip. Two locking running stitches run the entire 100mm band length creating a flat, low profile. A whipstitch on the side closes the band together. Implantation of the band is aided with the disposable band holder. The band is released from the holder by depressing the thumb trigger found on the handle of the holder. By depressing the thumb trigger, the holder bottom fingers push the band off of pins attached to the holder top. The device is sterilized by Steam Sterilization and has a One-year shelf life. The device is packaged on a holder in double aseptic pouches and shipped within a shelf-carton that includes instructions for use and product traceability labels.

The CG Future® Annuloplasty Band is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

The CG FUTURE Band is a single use, permanent, semi-rigid, implantable device intended for the repair of a patient's mitral valve. The CG FUTURE Band consists of a partial band of polyester fabric covering a formed, metallic (MP35N) wire stiffener material with eyelets formed at both ends. The stiffener element is over-molded with LSR silicone. The band is marked at three locations (the two trigone locations and the center) with green-colored suture. Two trigone markers identify the eyelets in the stiffener to facilitate anchoring of the stiffener into the trigones by the surgeon with sutures. The individual band size (26, 28, 30, 32, 34, 36, and 38mm) represents the widest, straight-line distance as measured at the inside of the fabric-covered band. The band is designed for implantation in the mitral position only. The CG FUTURE Band is used with associated accessories that include a holder, sizers and a handle. Implantation of the band is aided with the disposable band holder. The band is released from the holder by cutting suture at two points. The CG FUTURE Band sizer set is used to assess appropriate band size. The sizers cover all seven sizes of the CG FUTURE Band and are marked with the band size and the trigone locations. The sizers are reusable and are provided non-sterile. The reuseable annuloplasty handle, which is available in two lengths, interfaces with both the holder and the sizers.

The Duran Band (Model H607H), Duran Ring and Band (Models 610R and 610B), the Duran AnCore Ring and Band (Models 620R and 620B) and the Duran AnCore Ring and Band with Chordal Guide (Models 620R and 620B) are indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Note: The Chordal Guide feature of the Duran AnCore Ring/Band with Chordal Guide (Models 620R and 620B) is indicated only for chordal replacement surgery of pathological mitral valves.

The Duran product family (including the Duran products listed in Section II -DEVICE IDENTIFICATION), consist of permanent, implantable, flexible annuloplasty rings or bands made of polyester fabric with a 3-mm cross-section. A silicone marker, impregnated with barium sulfate enables radiographic visualization. The individual ring and band sizes range from 23mm to 35mm, in two-millimeter increments. The Duran products are used with associated accessories that include a holder, handle and sizers. The ring or band is provided on a holder to facilitate implantation of the device. The sizers are used to assess appropriate ring or band size and the handle interfaces with the holder to allow for proper positioning of the ring or band.