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The TVT device is intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI). The TVT device is intended to be used as a pubourethral sling indicated for treatment of stress urinary incontinence (SUI) for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The TVT Introducer, Rigid Catheter Guide and TVT abdominal Guides and Couplers accessories are intended to facilitate placement of the TVT device.

The Tension Free Vaginal Tape (TVT) System is comprised of three components; the device (TVT device) and its accessories (TVT Introducer and TVT Rigid Catheter Guide and TVT Abdominal Guides and Couplers). Each is available separately for use at the surgical site. The TVT device is composed of unpigmented or blue pigmented PROLENE polypropylene mesh (tape). The mesh is covered with a polyethylene sheath with a slit in the middle. Both the mesh and sheath are attached to two (2) stainless steel needles. The TVT Introducer (accessory) is made of stainless steel. It is composed of three (3) parts; handle, threaded shaft and rubber O-ring. The introducer functions to facilitate passage of the TVT device from the vagina to the abdominal skin. The TVT Rigid Catheter Guide is made of stainless steel and used to add rigidity to the Foley Catheter during the surgical procedure. The TVT AA (Accessory) Abdominal Guide is made of stainless steel and the couplers are made from polypropylene.