DynaMesh®-SIS direct
DynaMesh®-SIS direct, DynaMesh®-SIS direct soft and DynaMesh®-SIS direct visible implants are intended to be used as a midurethral sling for the surgical treatment of stress urinary incontinence caused by a hypermobile urethra and/or intrinsic sphincter deficiency. The devices permanently reinforce the soft tissue of the pelvic floor.
DynaMesh®-SIS directProduct RangeUse and PropertiesVideosFurther Product Information
Transobturator Tape Position: Outside-In
DynaMesh®-SIS direct, DynaMesh®-SIS direct soft and DynaMesh®-SIS direct visible are positioned using the outside-in technique in a transobturator tape position.
Several reusable instruments are available separately to position the device:
DynaMesh®-IST01
DynaMesh®-IST01/ DynaMesh®-IST02/ DynaMesh®-IST03:
Instrument set consisting of two instruments for transvaginal access for transobturator positioning of DynaMesh®-SIS direct, DynaMesh®-SIS direct soft and DynaMesh®-SIS direct visible using the outside-in technique.
DynaMesh®-IVT01
DynaMesh®-IVT01:
Instrument for transvaginal access for transobturator positioning of DynaMesh®-SIS direct, DynaMesh®-SIS direct soft and DynaMesh®-SIS direct visible using the outside-in technique.
| DynaMesh®-SIS direct |
01 cm x 50 cm | PV211050F1/F3 |
| DynaMesh®-SIS direct soft | 01 cm x 50 cm | PV411050F1/F3 |
| DynaMesh®-SIS direct visible |
01 cm x 50 cm | PV471050F1/F3 |
| FX = X unit(s)/box (e.g. F3 = 3 unit(s)/box) |
| Product | DynaMesh®-SIS direct (1) DynaMesh®-SIS direct soft (2) DynaMesh®-SIS direct visible (3) |
| Surgical Treatment | Stress Urinary Incontinence (SUI) |
| Surgical Approach | Transvaginal |
| Surgical Technique | TOT – Transobturator – Outside-In |
| Fixation | None |
| Smooth Warp-Knitted Selvedges |
 |
| Shape Stability |
[TR12, TR13] |
| Defined Elasticity |
[TR10] |
| Visible Technology |
 (1) (2) / (3) |
| Materials | – Polyvinylidene fluoride (PVDF) (CAS 24937-79-9) > 99% (w/w) (1) – (3) – Phthalocyanine green (CAS 1328-53-6) < 1% (w/w) (1) (2) – Triiron tetraoxide (CAS 1317-61-9) < 1% (w/w) (3) |
| 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, TR11] |
| Klinge’s Mesh Classification | Class 1a [102P, TR11] |
 |
Applicable |
 |
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 |
