GYNECARE TVT™ Device Tension Free Vaginal Tape - Female stress urinary incontinence surgical mesh

Intended purpose

The GYNECARE TVT Device is intended to be used as a pubo-urethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Functional description

Device is a sterile, single-use device, consisting of one piece of blue (Phthalocyanine blue, colour 74160) PROLENE™ Polypropylene Mesh (tape) approx 1.1 x 45 cm, covered by a plastic sheath cut & overlapping in the middle, held between two stainless steel needles bonded to mesh & sheath with plastic collars. The Sheath, needles, collars are cut & removed after mesh is placed. Reusable accessories(supplied separately),facilitate placement of device during procedure.