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Chord-X Pre-Measured Loops for Mitral Chordal Replacement are indicated for the repair or replacement of chordae tendinae.

The device is a non-absorbable monofilament ePTFE suture using 4 Chord-X ePTFE sutures in a looped configuration provided in the following sizes and meeting the USP standards: 2-0 Suture with 22mm Taper Point Needle (3/8 Circle and 1/2 Circle) and 18mm Taper Point Needle (3/8 Circle and 1/2 Circle) with adjustable loop lengths of 0, 12mm, 16mm, 20mm, and 24mm. Also, 3-0 Suture with 22mm Taper Point Needle (3/8 Circle and 1/2 Circle) and 18mm Taper Point Needle (3/8 Circle and 1/2 Circle) with adjustable loop lengths of 0, 12mm, 16mm, 20mm, and 24mm. All configurations are supplied with two (2) 0.118 X 0.276 X 0.059 inches (3 X 7 X 1.5 mm) pledgets. All suture strands used in the construction of the prosthesis are 32 inches in length. The loops are made simply as a convenience for the surgeon who currently must tie these at the operating table as described in the medical literature (Gillinov AM, Banbury MK. Pre-Measured Artificial Chordae for Mitral Valve Repair. Ann Thorae Surg 2007;84:2127-2129.) It eliminates a step in the operation. They are provided as sterile, single use products and contain no dyes or additives.