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

DM-SIS-transobturatoric

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:

Diameter : 5 -7 cm

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:
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	[2^A, 5^VIT, 27^A, 52^VIT, 93^A, 101]
Effective Porosity	High effective porosity reduces inflammation and the risk of excessive scar formation. [103^P, TR11]
Klinge’s Mesh Classification	Class 1a [102^P, 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

Videos: DynaMesh^®-SIS direct & DynaMesh^®-SIS direct soft

Posted: 17. June 2020 | 0 comments

- Animation -

DynaMesh^®-SIS direct - Animation: SUI Treatment - Transobturator (out/in) - TOT 8/4

- Animation -

DynaMesh^®-SIS direct - Animation: SUI Treatment - Transobturator (out/in) - TOT

- Animation & Operation -
english

englishDynaMesh^®-SIS direct soft - OR-Video: Treatment of Stress and Mixed Urinary Incontinence

- Animation & Operation -
english

englishDynaMesh^®-SIS direct soft - OR-Video: TOT 8/4 - Surgical Treatment of Urinary Stress Incontinence

germanDynaMesh^®-SIS direct soft - OP-Video: TOT 8/4 - Chirurgische Behandlung der Belastungsinkontinenz

DynaMesh^® Catalogue

Posted: 19. March 2021 | 0 comments

Download as PDF (english)

Als pdf herunterladen (deutsch)

DynaMesh^®-SIS

DynaMesh®-SIS, DynaMesh®-SIS soft and DynaMesh®-SIS 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®-SISProduct RangeUse and PropertiesVideosFurther Product Information

Retropubic Tape Position
(Inside-Out)

DM-SIS-retrosymphysary

Transobturator Tape Position
(Outside-In or Inside-Out)

DM-SIS-transobturatoric

DynaMesh®-SIS, DynaMesh®-SIS soft and DynaMesh®-SIS visible are positioned using the inside-out technique in case of a retropubic tape position, and using the outside-in or inside-out technique in case of a transobturator tape position.

The devices have a thread at the ends of the tape that is attached to the surgical instrument.

Several reusable instruments are available separately to position the device:

DynaMesh®-ISR01:
Instrument for transvaginal access for retropubic positioning of DynaMesh®-SIS, DynaMesh®-SIS soft and DynaMesh®-SIS visible using the inside-out technique.

Diameter: 5-7 cm

DynaMesh®-IST01 / DynaMesh®-IST02 / DynaMesh®-IST03:
Instrument set consisting of two instruments for transvaginal access for transobturator positioning of DynaMesh®-SIS, DynaMesh®-SIS soft and DynaMesh®-SIS visible using the inside-out or outside-in technique.

DynaMesh®-IVT01:
Instrument for transvaginal access for transobturator positioning of DynaMesh®-SIS, DynaMesh®-SIS soft and DynaMesh®-SIS visible using the outside-in technique.

DynaMesh®-SIS	01 cm x 50 cm	PV211056F1/F3
DynaMesh®-SIS soft	01 cm x 50 cm	PV411056F1/F3
DynaMesh®-SIS visible	01 cm x 50 cm	PV471056F1/F3
	FX = X unit(s)/box (e.g. F3 = 3 unit(s)/box)

Product	DynaMesh®-SIS⁽¹⁾ DynaMesh®-SIS soft⁽²⁾ DynaMesh®-SIS visible ⁽³⁾
Surgical Treatment	Stress Urinary Incontinence (SUI)
Surgical Approach	Transvaginal
Surgical Technique	TVT – Retropubic – Inside-Out / 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	[2^A, 5^VIT, 27^A, 52^VIT, 93^A, 101]
Effective Porosity	High effective porosity reduces inflammation and the risk of excessive scar formation. [103^P, TR11]
Klinge’s Mesh Classification	Class 1a [102^P, 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