Kasık Fıtığı
ENDOLAP 3D
DynaMesh®-ENDOLAP 3D ve DynaMesh®-ENDOLAP 3D görünür implantlar, kasık veya femoral fıtıkların cerrahi tedavisi için tasarlanmıştır ve fıtık defekti alanındaki kasık bölgesindeki yumuşak dokuyu kalıcı olarak köprülemek ve güçlendirmek için kullanılır.
Paylaş
3D Shape
The device is a preformed three-dimensional mesh with a green central longitudinal marking, a green edge marking and centrally attached green filament ends.
Standardised Positioning
The device must be placed in such a way that the central green longitudinal marking is aligned with the inguinal ligament, the green central filament ends are located in projection to the junction of the inferior epigastric blood vessels to the external iliac blood vessels, and the green edge marking points dorsocaudally. The green filament ends must point to the user.
Varying Pore Size
The pore size of the device varies laterally to the longitudinal marking.
When selecting and cutting the device, sufficient defect overlap must be ensured to minimise the likelihood of the hernia recurring.
| DynaMesh®-ENDOLAP 3D | 09 cm x 14 cm | PV130914F1/F3 |
| DynaMesh®-ENDOLAP 3D | 10 cm x 15 cm regular | PV131015F1/F3 |
| DynaMesh®-ENDOLAP 3D | 12 cm x 17 cm | PV131217F1/F5 |
| DynaMesh®-ENDOLAP 3D visible | 09 cm x 14 cm | PV120914F1/F3 |
| DynaMesh®-ENDOLAP 3D visible | 10 cm x 15 cm | PV121015F1/F3 |
| DynaMesh®-ENDOLAP 3D visible | 12 cm x 17 cm | PV121217F1 |
| FX = X unit(s)/box (e.g. F3 = 3 unit(s)/box) |
| Product | DynaMesh®-ENDOLAP 3D (1) DynaMesh®-ENDOLAP 3D visible (2) |
| Surgical Treatment | Inguinal Hernias / Femoral Hernias |
| Surgical Approach | Laparoscopic / Endoscopic |
| Surgical Technique | TAPP / TEP |
| Mesh Position | Preperitoneal (Posterior) |
| Fixation | (None)* / Sutures / Tissue Adhesives / Tacks |
| Green Central and Edge Marking |  |
| Visible Technology |  (1) /  (2) |
| Materials | – Polyvinylidene fluoride (PVDF) (CAS 24937-79-9) > 99% (w/w) (1) (2) – Phthalocyanine green (CAS 1328-53-6) < 1% (w/w) (1) (2) – Triiron tetraoxide (CAS 1317-61-9) < 1% (w/w) (2) |
| Polymer (Monofilament) |
PVDF
|
| Biocompatibility | [TR1] |
| Ageing Resistance |
[2A, 5VIT, 27A, 52VIT, 93A, 101] |
| Tear Propagation Resistance | [TR21] |
| Effective Porosity |
High effective porosity reduces inflammation and the risk of excessive scar formation. [103P, TR23] |
| Klinge’s Mesh Classification | Class 1a [102P, TR23] |
| * Based on current knowledge, with the exception of large direct inguinal hernias (European Hernia Society classification: M3), it appears possible to dispense with any form of fixation. |
|
Applies to all product sizes |
|
Does not apply |
| [#] | Reference “#”(see “References”) |
| [TR#] | Internal test report (see “internal test report references”) |
| Limitations | “A” animal trial, “B” bench test, “VIT” in-vitro trial, “P” published results based on the analysis of human mesh explants, “PB” published results mainly based on bench tests |
