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C
L/P Mesh with
™
Low Profi le Polypropylene & ePTFE Mesh with Positioning System
Designed for Laparoscopic Ventral Hernia Repair
Includes:
Instructions for Use
Single Use
Do not Resterilize
Product Description
C
™ L/P Mesh with E
PS™ Positioning System (the device) is a non-absorbable sterile prosthesis,
OMPOSIX
CHO
with a pre-attached removable positioning system, designed for the reconstruction of soft tissue defi ciencies
during laparoscopic ventral hernia repair.
C
™ L/P Mesh is pre-sized to offer maximum ready-to-use benefi ts and its lower profi le facilitates
OMPOSIX
laparoscopic deployment. It is constructed of one layer of B
of knitted polypropylene monofi laments, and one layer of expanded polytetrafl 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 monofi lament. For
maximum performance, the edge of the polypropylene mesh layer is heat sealed to the ePTFE layer.
The E
PS™ Positioning System is made up of a thermoplastic coated nylon balloon with infl ation tube
CHO
which is pre-attached to the C
™ L/P Mesh with small connectors. Once inserted, the balloon is infl ated
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with the included infl 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
completely removed from the body. (See Section 4, Directions for Using C
Positioning System.)
All sizes of C
™ L/P Mesh with E
PS™ Positioning System are packaged with an Introducer Tool.
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CHO
The Introducer Tool consists of a metal tines/T-cap assembly which is used to roll C
E
PS™ Positioning System in order to facilitate laparoscopic introduction.
CHO
T-cap
Tines
Indications
C
™ L/P Mesh is indicated for use in the reconstruction of soft tissue defi ciencies, such as for the repair
OMPOSIX
of hernias and chest wall defects.
The E
PS™ Positioning System is intended to be used to facilitate the delivery of soft tissue prostheses
CHO
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
™ L/P Mesh with E
OMPOSIX
future growth will be compromised by use of such material.
3.
Do not use C
™ L/P Mesh with E
OMPOSIX
CHO
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
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
PS™ Positioning System.
CHO
8.
The E
PS™ Positioning System should not be used with any other hernia prosthesis aside
CHO
from those with which it comes pre-attached/packaged.
9.
C
™ L/P Mesh is the only permanent implant component of the device. The infl ation adapter
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and syringe are to be kept external to the patient and discarded after use. The E
ing System (including the balloon, all connectors, and infl 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
(including the infl 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.
PK3796862 BAW-35.indd 2
PK3796862 BAW-35.indd 2
E
PS
Positioning System
™
Introducer Tool
Infl ation Assembly
Non-absorbable
B
Soft Mesh layer
®
ARD
ePTFE layer
E
PS™ Positioning System
CHO
®
Soft Mesh, which has a large pore design
ARD
PS™ Positioning System is
CHO
™ L/P Mesh with E
OMPOSIX
™ L/P Mesh with
OMPOSIX
Inflation
Tube
PS™ Positioning System in infants or children whereby
CHO
PS™ Positioning System for the reconstruction of cardiovas-
™ L/P Mesh with E
OMPOSIX
PS ™ Position-
CHO
PS ™ Positioning System
CHO
Precautions
1.
Please read all instructions prior to use.
2.
Only physicians qualifi 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 suffi 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
only
orientation sutures.
If transfascial sutures are to be used for fi xation, place sutures after removing the E
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
™ L/P Mesh (that contains the E
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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
Mesh with E
PS™ Positioning System along the long axis with the polypropylene on the outside and insert
CHO
into the abdomen through the recommended minimum trocar as per the table below. Do not force the device
through the trocar. If the C
™ L/P Mesh with E
OMPOSIX
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
Mesh Size
(REF)
PS™
CHO
0144680
6.2" x 8.2" / 15.9 cm x 21.0 cm
0144610
6.2" x 10.2" / 15.9 cm x 26.1 cm
0144790
7.2" x 9.2" / 18.4 cm x 23.5 cm
0144810
8.2" x 10.2" / 21.0 cm x 26.1 cm
0144113
10.2" x 13.2" / 26.1 cm x 33.7 cm
0144114
10.2" x 14.2" / 26.1 cm x 36.2 cm
* 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
™ L/P Mesh with E
OMPOSIX
ducer Tool from the sterile pouch. Set infl 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
logo and dark shaded areas on the device represent the long axis). Ensure that
®
ARD
the device is centered on the tines and that the infl 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 infl 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 suffi cient visualization of the device and the surrounding
anatomy.
Fig. 1
Fig. 2
7.
As the device is being deployed through the trocar, rotate the tines handle in the direction that the device
PS™
CHO
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
PS™ Positioning System eliminates the need for transfascial
CHO
CHO
PS™ Positioning System) must always be positioned
CHO
PS™ Positioning System will not easily deploy down
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# of Mesh
Recommended Minimum
Description
Connectors
Trocar Size*
4
Ellipse
4
Oval
4
Ellipse
4
Ellipse
8
Ellipse
8
Rectangle
PS™ Positioning System (the device) and included Intro-
CHO
Fig. 3
Fig. 4
Fig. 7
Fig. 8
PS™ Positioning
™ L/P
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12 mm
12 mm
12 mm
12 mm
15 mm
15 mm
10/5/2011 1:01:24 PM
10/5/2011 1:01:24 PM
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