On-X CHORD-X ePTFE SUTURE, Instructions For Use Manual

Page: 8 / 80

English
8
English
9
6.2.1. References:
Zussa, Claudio, Different
applications of ePTFE valve
chordae: surgical techniques.
J Heart Valve Disease , 1996;
5:356-361.
Frater, RWM, Gabbay, S, Shore, D,
et al. Reproducible replacement of
elongated or ruptured mitral valve
chordae.
Ann Thorac Surg , 1983;
35; 14-28.
Zussa, Claudio, Artificial Chordae
in Mitral Valve Surgery . Austin:
R.G. Landes Company, 1994: 159.
7. ADVERSE REACTIONS
Potential adverse effects associated
with the use of any suture include:
wound dehiscence, infection, and
localized transitory inflammatory
tissue reaction.
8. HOW SUPPLIED
Chord-X ePTFE Sutures for Chordae
Tendineae Repair or Replacement
are available as sterile strands in USP
2-0 and USP 3-0 with either 1/2 or
3/8 circular taper point needles and
without pledgets.
Chord-X ePTFE Sutures for Chordae
Tendineae Repair or Replacement
are supplied
STERILE unless the
integrity of the package has been
compromised. Do not use the