Hiatal Hernia
HIATUS
DynaMesh®-HIATUS implants are intended for the surgical treatment of axial and/or paraoesophageal hiatal hernias, if a high risk of recurrence is expected with hiatoplasty using a simple suture technique. The devices permanently reinforce the soft tissue of the diaphragm in the region of the oesophageal hiatus.
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Defined Stability
Constriction of the mesh in the region of the hiatus may reduce the distance between the mesh implant and the oesophagus. DynaMesh®-HIATUS implants have rectangular pores and defined stability with a maximum elongation of only 8% [TR50, TR51].
Effective Porosity
All DynaMesh®-HIATUS implants have an effective porosity [TR51]. DynaMesh®-HIATUS implants are made of PVDF. PVDF has good biocompatibility, reducing the foreign body reaction compared to other materials such as polypropylene [1A, 2A, 4A, 68A, 100A, TR1].
DynaMesh®-HIATUS implants show little mesh shrinkage [51].
Smooth Warp-Knitted Selvedges
All DynaMesh®-HIATUS implants have smooth warp-knitted
selvedges.
| [#] | 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 |
When selecting and cutting the device, ensure that the mesh implant adequately overlaps the hernial orifice on all sides.
| DynaMesh®-HIATUS | 07 cm x 12 cm | PV610712F1/F3 |
| DynaMesh®-HIATUS | 08 cm x 13 cm | PV610813F1/F3 |
| FX = X unit(s)/box (e.g. F3 = 3 unit(s)/box) |
| Product | DynaMesh®-HIATUS |
| Surgical Treatment | Hiatal Hernias |
| Surgical Approach | Minimally Invasive / Open |
| Surgical Technique | Cruroplasty with mesh reinforcement |
| Fixation | Suture* / Tissue Adhesives / Tacks* |
| Defined Stability |
 [TR50] |
| Smooth Warp-Knitted Selvedges |
|
| Visible Technology |
|
| Materials | – Polyvinylidene fluoride (PVDF) (CAS 24937-79-9) > 99% (w/w) – Triiron tetraoxide (CAS 1317-61-9) < 1% (w/w) |
| Polymer (Monofilament) | PVDF |
| Biocompatibility |
[TR1] |
| Ageing Resistance |
[2A, 5VIT, 27A, 52VIT, 93A, 101] |
| Effective Porosity |
High effective porosity reduces inflammation and the risk of excessive scar formation. [103p, TR51] |
| Klinge’s Mesh Classification | Class 1a [102P, TR51] |
| * Traumatic fixation may only be used if injuries to the pericardium, aorta or vena cava can be ruled out with total certainty. |
|
Applies to all product sizes |
| [#] | 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 |
