Composite mesh
<p>The Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists.</p>
| Device classification | Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving primary abdominal wall and incisional hernia surgeries. |
|---|---|
| Material composition |
|
| Pore size | 2.1 mm x 3.0 mm (white textile) |
| Sterilization method | Gamma radiation |
| Shelf life | 5 years |
Symbotex™ composite mesh should be hydrated in its original blister before being handled.
Yes, one or the other is necessary. However, the technique used to anchor the mesh (suture and/or tack) is left up to the practitioner.
| Item number | Size (cm) | Diameter (cm) | Units per box |
|---|---|---|---|
| SYM8OS | — | 8 | 1 |
| SYM9 | — | 9 | 1 |
| SYM12 | — | 12 | 1 |
| SYM15 | — | 15 | 1 |
| SYM20 | — | 20 | 1 |
| SYM1510 | 15 × 10 | — | 1 |
| SYM1510OS | 15 × 10 | — | 1 |
| SYM2520 | 25 × 20 | — | 1 |
| SYM1710E | 17 × 10 | — | 1 |
| SYM2012E | 20 × 12 | — | 1 |
| SYM2015 | 20 × 15 | — | 1 |
| SYM2015OS | 20 × 15 | — | 1 |
| SYM2515E | 25 × 15 | — | 1 |
| SYM2520OS | 25 × 20 | — | 1 |
| SYM3020 | 30 × 20 | — | 1 |
| SYM3020OS | 30 × 20 | — | 1 |
| SYM3420E | 34 × 20 | — | 1 |
| SYM3728 | 37 × 28 | — | 1 |
| SYM4024E | 40 × 24 | — | 1 |
| SYM4232 | 42 × 32 | — | 1 |
Parietex™ composite mesh is used for the reinforcement of tissues during surgical repairs including hiatal hernias.
Parietex™ optimized composite mesh is intended for the reinforcement of abdominal wall soft tissues where a weakness exists.
Refer to the indications for use for complete instructions.
† Based on preclinical animal studies and benchtop studies. Animal data and benchtop testing are not necessarily indicative of human clinical outcomes.
‡ Based on preclinical animal studies. Animal data is not necessarily indicative of human clinical outcomes.
§ If the mesh is not cut (refer to instructions for use). Particular attention should be paid not to cut the green marking. It may no longer be centered and lose its functions if the mesh is trimmed.
◊ Not applicable for SYM-OS codes. Except in cases where transfacial sutures are used as well as meshes in open approach.
¶ Based on surgeon feedback and that 4/6 answers good or very good clinging effect.
# Tissue reinforcement and integration are indirectly assessed in clinical studies by the reported low recurrence rates.
∆ Minimization of visceral adhesions are indirectly assessed in clinical studies by the absence of adhesion complications.
∞ Based on benchtop studies. Benchtop testing data is not necessarily indicative of human clinical outcomes.
†† Clinical outcomes expressed by low hernia recurrence rates and improvement in the quality of life.
‡‡ Except in cases where transfacial sutures are used as well as meshes in open approach. Based on surgeon feedback and that 4/6 answers good or very good clinging effect.