en
DESCRIPTION
V
ENTRIO
™ ST Hernia Patch is a self-expanding bioresorbable coated, partially absorbable, sterile prosthesis,
containing 2 distinct layers stitched together with PTFE mono
fi
lament, forming a positioning pocket. The
top layer is mono
fi
lament polypropylene mesh and the bottom layer is S
EPRAMESH
™ IP Composite mesh.
S
EPRAMESH
™ IP Composite is co-knitted using polypropylene (PP) and polyglycolic acid (PGA)
fi
bers to result
in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a
bioresorbable, chemically modi
fi
ed sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene
glycol (PEG) based hydrogel (
see Figure 1
).
The fascial side of the mesh allows a prompt
fi
broblastic response through the interstices of the mesh, allowing
for tissue ingrowth into the mesh. The visceral side of the mesh is a bioresorbable coating, separating the mesh
from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement,
the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.
The device contains S
ORBA
F
LEX
™ Memory Technology, which provides memory and stability to the device,
facilitating ease of initial insertion, proper placement, and
fi
xation of the device. The S
ORBA
F
LEX
™ Memory
Technology is comprised of an extruded polydioxanone (PDO) mono
fi
lament that is contained within a
knitted polypropylene mesh tube. The extra large oval size patches contain two separate S
ORBA
F
LEX
™
PDO mono
fi
laments (
see Figure 1
). The S
ORBA
F
LEX
™ PDO mono
fi
lament fully degrades in vivo by means
of hydrolysis. The PDO mono
fi
lament has been found to elicit an in
fl
ammatory response during absorption.
Absorption is essentially complete in 6-8 months.
INDICATIONS
The V
ENTRIO
™ ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists,
in procedures involving soft tissue repair, such as for the repair of hernias.
CONTRAINDICATIONS
1. Do not use the V
ENTRIO
™ ST Hernia Patch in infants or children, whereby future growth will be compromised
by use of such mesh material.
2. Do not use the V
ENTRIO
™ ST Hernia Patch for the reconstruction of cardiovascular defects.
3. Literature reports that there may be a possibility for adhesion formation when the polypropylene is placed
in contact with the bowel or viscera.
WARNINGS
1. The device is supplied sterile. Inspect the packaging to be sure it is intact and undamaged prior to
use.
2. This device is for single use only. Do not resterilize or reuse any portion of the V
ENTRIO
™ ST Hernia
Patch. Product should be used once exterior foil pouch has been opened. Do not store for later use.
3.
Do not cut or reshape the V
ENTRIO
™ ST Hernia Patch, as this could impact its effectiveness.
Care should be taken not to cut or nick the S
ORBA
F
LEX
™ PDO mono
fi
lament during insertion or
fi
xation. If the S
ORBA
F
LEX
™ PDO mono
fi
lament is cut or damaged, additional complications
may include bowel or skin perforation and infection.
4. Follow proper folding techniques for all patches as described in these Instructions for Use as other
folding techniques may compromise the S
ORBA
F
LEX
™ PDO mono
fi
lament (
see Figure 2
).
5. Ensure proper orientation; the bioresorbable coated side of the prosthesis should be oriented
against the bowel or sensitive organs. Do not place the polypropylene mesh side against the bowel.
There may be a possibility for adhesion formation when the mesh is placed in direct contact with
the bowel or viscera.
6. To ensure a strong repair, the prosthesis should be secured with tacks or sutures through the
polypropylene mesh structure or full device. Suturing or tacking on edge of mesh alone is not
recommended.
7. The use of any permanent mesh or patch in a contaminated or infected wound could lead to
fi
stula
formation and/or extrusion of the prosthesis.
8. 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.
S
ORBA
F
LEX
™ PDO
Mono
fi
lament
Figure 1
Mono
fi
lament
Polypropylene Mesh
S
EPRAMESH
™ IP
Composite
Visceral Side
Fascial Side
V
ENTRIO
™
ST
Hernia Patch
Self-Expanding Bioresorbable Coated Permanent Mesh for Soft Tissue Reconstruction
with S
ORBA
F
LEX
™ Memory Technology
PK3794572 BAW-9.indd 2
PK3794572 BAW-9.indd 2
6/3/2011 8:48:09 AM
6/3/2011 8:48:09 AM
