Jotec On-X Life CHORD-X Mode D'emploi

CHORD-X™ CHORDAL SIZER
INSTRUCTIONS FOR USE
1. DESCRIPTION
The Chord-X™ Chordal Sizer (see Figure
1) is designed to assist the surgeon in
determining the proper length of chordal
replacement prostheses needed to repair
the mitral valve. It may be used to help the
surgeon select a preconfigured prosthesis,
or to easily configure the correct size using
straight suture material, during mitral valve
repair.
2. INDICATIONS
Chord-X™ Chordal Sizer is indicated for
sizing or configuring chordal replacement
prostheses during mitral valve repair.
3. CONTRAINDICATIONS
None known.
4. PRECAUTIONS AND WARNINGS
Successful use of this device requires
appropriate training and experience in
cardiac surgical techniques including
mitral valve repair. The replacement
of chordae tendinae requires accurate
sizing to ensure satisfactory functioning
of the valve mechanism post repair or
replacement. Chordae tendinae replaced
with sutures that are either too long or too
short can result in failure to correct valvular
incompetence.
The device has been sterilized using gamma
irradiation. It is provided sterile unless
the integrity of the package has been
compromised. Do not use the device if the
package has been compromised. Do not re-
sterilize. Do not Reuse. Reuse may result in
infection, serious injury, or patient death.
On-X Life Technologies, Inc.
1300 East Anderson Lane, Bldg. B, Austin Texas 78752 U.S.A.
TEL: (512) 339-8000 FAX: (512) 339-3636
WEB: www.onxlti.com EMAIL: onx@onxlti.com
JOTEC GmbH, a fully owned subsidiary of CryoLife, Inc.
Lotzenäcker 23
72379 Hechingen. GERMANY
102122 02 H English
(2020-12)
5. RECOMMENDED TECHNIQUES
Note: These instructions only cover the sizing
step of chordae tendineae repair. Please
see the Chord-X ePTFE Suture or Chord-X
Pre-Measured Loops Instructions for Use for
further instruction.
Use the blue leaflet hook to support the
•
edge of the leaflet in the planned position.
Use the thumb-slide to extend the
•
papillary hook to the planned site of
attachment to the papillary muscle as
shown in Figure 2.
The leaflet hook may be rotated to any
•
desired angle relative to the papillary
hook to improve visibility. Rotate the
leaflet hook by using the grips at the base
of the barrel.
The colors of scale match the label colors
•
for the corresponding Chord-X Pre-
Measured Loops prostheses.
The scale number indicates the size of
•
chordal loops produced by tying suture
around the two hooks. The scale is
accurate to ±1mm. Rotate the barrel so
that the leaflet hook is aligned with the
papillary hook prior to tying loops. After
tying, pull the papillary hook back to
remove tied loops from the hooks.
Once the artificial chordae tendineae are
•
in place, a saline test is recommended to
verify that the chordal loop size is correct
and that the valve is competent.
Gamma CXCS
Papillary Hook
Leaflet Hook
Barrel
Grips for
Barrel Rotation
Thumb-Slide
12
Scale
mm
16
mm
20
Figure 1:
Chordal Sizer
Free Edge of
Mitral Leaflet
Planned Site of
Papillary Muscle
Attachment
Figure 2:
Sizing
English