Device Dossier
Chord-X Pre-Measured Loops - Suture, polytetrafluoroethylene
Device Dossier for Chord-X Pre-Measured Loops - Suture, polytetrafluoroethylene (Suture, polytetrafluoroethylene, Class III, sponsor Device…
- GMDN category: Suture, polytetrafluoroethylene
- Sponsor: Device Technologies
Intended purpose
The expanded polytetrafluoroethylene sutures are intended for the repair or replacement of chordae tendinae.
Functional description
Chord-X Pre-Measured Loops is an artificial chordal replacement prosthesis configured from nonabsorbable, monofilament suture made from expanded polytetrafluoroethylene (ePTFE). The suture is undyed and contains no additives. Configured with pre-measured, pre-knotted ePTFE suture loops with double-armed taper point needles attached. 2 PTFE pledgets are for papillary attachment, 3 chordal suture loops for the leaflet, and 1 suture pair with an attached pledget for the papillary muscle.