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The SiiS#1 Device is intended to be used as a pubourethral sling for treatment of Stress Urinary Incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. Indications (from labeling): The SiiS#1 device is intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The SiiS#1 Inserter, Sling Locater and Urethral Probe are available and intended to facilitate placement of the SiiS#1 device. The SiiS#1 Bladder-Neck Suspension Device is a sterile, single-use device intended to be used as a pubourethral sling for treatment of stress urinary incontinence (SUI), for female urinary incontinence resulting form urethral hypermobility and/or intrinsic sphincter deficiency. The SiiS#1 Bladder-Neck Suspension Device Inserter, and Sling Locator are provided and are intended to facilitate the placement of the SiiS#1 Bladder-Neck Suspension Device.

The SiiS#1 Tissue Suspension Device is a sterile single use device, consisting of one piece of undyed polyester tubular mesh approximately 6 mm diameter x 305 mm long (.250 x 12 inches) with both ends terminating in toggle type tissue anchors. The anchors and part of the mesh are held within a long needle inserter. Attached to the mesh creating a secondary sling is a sliding mesh approximately 80 mm long connected to the longer mesh with sliding locks. The sliding locks are advanced with the sling locator to shorten the length of the sling until desired length is achieved. Polyester tubular mesh is constructed of knitted filaments of extruded polyester strands identical in composition to that used in polyester non-absorbable surgical suture. The material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use. The SiiS#1 Inserter is provided sterile and single use. The inserter is made of stainless steel with an anodized aluminum handle. The tip of the inserter is constructed to accept the toggle anchors and part of the tubular mesh. The inserter is intended to facilitate the passage of the toggle anchors through the rectus fascia below the abdominal skin. The SiiS#1 Reusable Sling Locator is provided sterile and single use. The locator is made of polyacetal or equivalent and is intended to facilitate the position of the sliding sling on the longer suspender. It is connected and fixed to the longer suspender and interfaces with the sliding sling adjustment locks.