Device Dossier
GYNECARE TVT™ Obturator System - Female stress urinary incontinence surgical mesh
Device Dossier for GYNECARE TVT™ Obturator System - Female stress urinary incontinence surgical mesh (Female stress urinary incontinence surgical mesh,…
- GMDN category: Female stress urinary incontinence surgical mesh
- Sponsor: Endotherapeutics
Intended purpose
The GYNECARE TVT Obturator Device is intended to be used in women as a sub-urethral sling for the treatment of stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Functional description
Procedural kit:1 TVT Obturator device, 2 TVT Helical Passers, 1 Atraumatic Winged Guide. Obturator device,consist one piece blue(phthalocyanine blue,colour 74160)PROLENE Polypropylene Mesh aprox 1.1x45cm covered by plastic sheath with overlap in middle.White plastic tubes attached each end sheath/mesh & accommodates Helical Passers. HPs assembled to device,used to deliver mesh implant via trans-obturator inside-out approach.Atraumatic Winged Guide facilitates passage of HPs thru dissection tract