Device Dossier
GYNECARE TVT™ EXACT™ Continence System - Female stress urinary incontinence surgical mesh
Device Dossier for GYNECARE TVT™ EXACT™ Continence System - Female stress urinary incontinence surgical mesh (Female stress urinary incontinence surgical…
- GMDN category: Female stress urinary incontinence surgical mesh
- Sponsor: Endotherapeutics
Intended purpose
The GYNECARE TVT EXACT Continence System is intended to be used as a pubo-urethral sling for treatment of female Stress Urinary Incontinence, resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Functional description
Continence System Trocar Sheath/Implant Assembly consists of one piece blue(Phthalocyanine blue,colour 74160) PROLENE™ Polypropylene Mesh (tape)approx 1.1x45cm, covered by clear plastic sheath held between two white trocar sheaths,which are bonded to implant & implant sheath.Trocar Shaft fit inside white Trocar Sheaths,used to position system from vaginal incision up through abdominal wall.Rigid Catheter Guide is nonsterile reusable available separately,intended to facilitate placement TVT EXACT