Device Dossier
GYNECARE TVT™ ABBREVO™ Continence System - Female stress urinary incontinence surgical mesh
Device Dossier for GYNECARE TVT™ ABBREVO™ Continence System - Female stress urinary incontinence surgical mesh (Female stress urinary incontinence…
- GMDN category: Female stress urinary incontinence surgical mesh
- Sponsor: Endotherapeutics
Intended purpose
GYNECARE TVT™ ABBREVO™ Continence System is intended for use in women as a sub-urethral sling for the treatment of SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Functional description
Procedural kit:TVT ABBREVO Implant Assembly(Mesh implant & sheath,Polyethylene Tube Receptacles/Helical Passers,Placement Loop with attached Polypropylene Button,Positioning Lines & Atraumatic Winged Guide. Curved HPs preassembled to implant assembly to deliver mesh implant via trans-obturator insideout approach.Atraumatic Winged Guide facilitates passage of HPs thru dissection tract, marked with Insertion Zone-aids surgeon’s assessment of inserted depth. IZ indicates distance 3-4cm from tip WG.