en
C
™
L/P
Mesh with
E PS
™
Positioning System
Low Profi le Polypropylene & ePTFE Mesh with Positioning System
Designed for Laparoscopic Ventral Hernia Repair
Includes:
Introducer Tool
Infl ation Assembly
Instructions for Use
Single Use
Do not Resterilize
Non-absorbable
only
Product Description
C
OMPOSIX
™ L/P Mesh with E
CHO
PS™ Positioning System (the device) is a non-absorbable sterile prosthesis,
with a pre-attached removable positioning system, designed for the reconstruction of soft tissue de
fi
ciencies
during laparoscopic ventral hernia repair.
B
ARD
®
Soft Mesh layer
ePTFE layer
E
CHO
PS™ Positioning System
C
OMPOSIX
™ L/P Mesh is pre-sized to offer maximum ready-to-use bene
fi
ts and its lower pro
fi
le facilitates
laparoscopic deployment. It is constructed of one layer of B
ARD
®
Soft Mesh, which has a large pore design
of knitted polypropylene mono
fi
laments, and one layer of expanded polytetra
fl
uoroethylene (ePTFE). The
ePTFE sheet is extruded and expanded to impart a low porosity. The mesh surface allows for tissue ingrowth
while the ePTFE minimizes tissue attachment. The layers are stitched together with PTFE mono
fi
lament. For
maximum performance, the edge of the polypropylene mesh layer is heat sealed to the ePTFE layer.
The E
CHO
PS™ Positioning System is made up of a thermoplastic coated nylon balloon with in
fl
ation tube
which is pre-attached to the C
OMPOSIX
™ L/P Mesh with small connectors. Once inserted, the balloon is in
fl
ated
with the included in
fl
ation assembly to help facilitate laparoscopic deployment, including unrolling, position-
ing, and placement of the mesh. Once initial mesh
fi
xation is complete the E
CHO
PS™ Positioning System is
completely removed from the body. (See Section 4, Directions for Using C
OMPOSIX
™ L/P Mesh with E
CHO
PS™
Positioning System.)
All sizes of C
OMPOSIX
™ L/P Mesh with E
CHO
PS™ Positioning System are packaged with an Introducer Tool.
The Introducer Tool consists of a metal tines/T-cap assembly which is used to roll C
OMPOSIX
™ L/P Mesh with
E
CHO
PS™ Positioning System in order to facilitate laparoscopic introduction.
Indications
C
OMPOSIX
™ L/P Mesh is indicated for use in the reconstruction of soft tissue de
fi
ciencies, such as for the repair
of hernias and chest wall defects.
The E
CHO
PS™ Positioning System is intended to be used to facilitate the delivery of soft tissue prostheses
during laparoscopic hernia repair.
Contraindications
1. Literature reports there is a possibility for adhesion formation when the polypropylene is placed in direct
contact with the bowel or viscera.
2. Do not use the C
OMPOSIX
™ L/P Mesh with E
CHO
PS™ Positioning System in infants or children whereby
future growth will be compromised by use of such material.
3. Do not use C
OMPOSIX
™ L/P Mesh with E
CHO
PS™ Positioning System for the reconstruction of cardiovas-
cular defects.
Warnings
1. This device is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior
to use.
2. This device has been designed for single use only. Reuse, resterilization, reprocessing and/or
repackaging may compromise the structural integrity and/or essential material and design char-
acteristics that are critical to the overall performance of the device and may lead to device failure
which may result in injury to the patient. Reuse, reprocessing, resterilization, or repackaging may
also create a risk of contamination of the device and/or cause patient infection or cross infection,
including, but not limited to, the transmission of infectious diseases from one patient to another.
Contamination of the device may lead to injury, illness, or death of the patient or end user.
3. Ensure proper orientation; the solid white surface (ePTFE) of C
OMPOSIX
™ L/P Mesh with E
CHO
PS™
Positioning System must be oriented against the bowel or sensitive organs. Do not place the
polypropylene mesh surface against the bowel. There is a possibility for adhesion formation
when polypropylene mesh is placed in direct contact with the bowel or viscera.
4. The use of any permanent mesh or patch in a contaminated or infected wound could lead to infec-
tion,
fi
stula formation and/or extrusion of the prosthesis.
5. If an infection develops, treat the infection aggressively. Consideration should be given regarding
the need to remove the prosthesis. An unresolved infection may require removal of the prosthesis.
6. To prevent recurrences when repairing hernias, it is recommended that the prosthesis be large
enough to extend at least 3 to 5 cm beyond the margins of the defect.
7. Do not apply sharp, heat emitting, or ultrasonic tools (such as scissors, needles, tackers, diather-
mic tools, etc.) to the E
CHO
PS™ Positioning System.
8. The E
CHO
PS™ Positioning System should not be used with any other hernia prosthesis aside
from those with which it comes pre-attached/packaged.
9. C
OMPOSIX
™ L/P Mesh is the only permanent implant component of the device. The in
fl
ation adapter
and syringe are to be kept external to the patient and discarded after use. The E
CHO
PS ™ Position-
ing System (including the balloon, all connectors, and in
fl
ation tube) is to be removed from the
patient and appropriately discarded as it is not part of the permanent implant.
10.
Discard Introducer Tool and all components of the E
CHO
PS ™ Positioning System
(including the in
fl
ation adapter and syringe) after use. This product may be a potential
biohazard. Handle and dispose in accordance with accepted medical practice and
applicable local, state and federal laws and regulations.
T-cap
Tines
Inflation
Tube
Precautions
1. Please read all instructions prior to use.
2. Only physicians quali
fi
ed in the appropriate surgical techniques should use this device.
3. Visualization should be maintained throughout the course of the entire procedure. Additionally,
laparoscopic removal of the balloon device must be performed under suf
fi
cient visualization of the device
and surrounding anatomy, to ensure safe and proper device removal.
4. Do not trim the mesh. This will affect the interface between the mesh and positioning system.
Instructions for Use
Note on Transfascial Sutures:
The E
CHO
PS™ Positioning System eliminates the need for transfascial
orientation sutures.
If transfascial sutures are to be used for
fi
xation, place sutures after removing the E
CHO
PS™ Positioning
System from the body and after completing all mechanical
fi
xation.
1) Surface Orientation
It is extremely important that this product be oriented correctly to function as intended. The solid white (ePTFE)
surface of C
OMPOSIX
™ L/P Mesh (that contains the E
CHO
PS™ Positioning System) must always be positioned
against those surfaces where minimal tissue attachment is desired, i.e., against bowel or other visceral struc-
tures. The solid white (ePTFE) surface is designed with low porosity to minimize tissue attachment to the pros-
thesis. It is still recommended to pull down omentum wherever possible beneath the device to further mitigate
the risk of visceral adhesion. The polypropylene mesh side offers the same tissue ingrowth characteristics of
polypropylene mesh alone. Therefore, this side should face the surface where tissue ingrowth is desired. The
polypropylene mesh surface should never be placed against the bowel or other visceral structures.
2) Trocar Size Recommendations
Using the Introducer Tool (See Section 3, Directions for Using the Introducer Tool) roll the C
OMPOSIX
™ L/P
Mesh with E
CHO
PS™ Positioning System along the long axis with the polypropylene on the outside and insert
into the abdomen through the recommended minimum trocar as per the table below. Do not force the device
through the trocar. If the C
OMPOSIX
™ L/P Mesh with E
CHO
PS™ Positioning System will not easily deploy down
the trocar, remove the trocar and insert through the next largest available size trocar or through the trocar
incision site and reinsert trocar.
Product Code
(REF)
Mesh Size
# of Mesh
Connectors
Description
Recommended Minimum
Trocar Size*
0144680
6.2” x 8.2” / 15.9 cm x 21.0 cm
4
Ellipse
12 mm
0144610
6.2” x 10.2” / 15.9 cm x 26.1 cm
4
Oval
12 mm
0144790
7.2” x 9.2” / 18.4 cm x 23.5 cm
4
Ellipse
12 mm
0144810
8.2” x 10.2” / 21.0 cm x 26.1 cm
4
Ellipse
12 mm
0144113
10.2” x 13.2” / 26.1 cm x 33.7 cm
8
Ellipse
15 mm
0144114
10.2” x 14.2” / 26.1 cm x 36.2 cm
8
Rectangle
15 mm
* If a proximal cap is available on the trocar, removing the proximal cap can help facilitate deployment.
Deployment capability may vary depending on rolled patch size and graspers/trocars used.
3) Directions for Using the Introducer Tool
1. Remove
the
C
OMPOSIX
™ L/P Mesh with E
CHO
PS™ Positioning System (the device) and included Intro-
ducer Tool from the sterile pouch. Set in
fl
ation assembly pouch aside.
2. Place the device lengthwise between the metal tines approximately 2.5 cm to 5 cm from the long edge
of the device (The B
ARD
®
logo and dark shaded areas on the device represent the long axis). Ensure that
the device is centered on the tines and that the in
fl
ation tube is lying
fl
at and facing the proximal end of
the tool in parallel to the rolling tines (Fig. 1).
3. Place T-cap on the end of the tines (Fig. 2).
4. Grasp the center of the device/tines to provide counter pressure against the device/tines. With one hand
roll the device, polypropylene side out, by turning the tines handle until the device is completely wrapped
around the tines. Ensure the in
fl
ation tube is not wrapped around the mesh (Fig. 3).
5. Remove the T-cap. Ensure the device is positioned such that at least ½ cm of the tines extends beyond
the mesh edge (Fig. 4).
6. Deliver the device through the trocar under suf
fi
cient visualization of the device and the surrounding
anatomy.
Fig. 1 Fig. 2 Fig. 3 Fig. 4
7. As the device is being deployed through the trocar, rotate the tines handle in the direction that the device
was rolled. This will keep the device tight around the tines, thus facilitating deployment (Fig. 5).
8. To release the device from the Introducer Tool, rotate the tines handle approximately ½ turn in the oppo-
site direction the device was rolled and partially slide the tines handle out of the device. Do not completely
remove the tines from the device until the device has passed through the trocar entirely (Fig. 6, Fig. 7).
Note:
If the tines are removed from the device before it is completely deployed through the trocar, use
the laparoscope to push the mesh through the trocar, or use a grasper from an opposing trocar location
to pull the mesh through.
9. Under visualization, continue to advance the device and tines though the trocar. Repeat the previous
steps and rotate the tines handle in the direction the device was rolled to completely deploy the patch
through the trocar (Fig. 8).
10. After the device has cleared the trocar, remove the tines from the trocar and discard appropriately.
Fig. 5 Fig. 6 Fig. 7 Fig. 8
PK3796862 BAW-35.indd 2
PK3796862 BAW-35.indd 2
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