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The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Aris Transobturator Kit consists of the Aris implantable midurethral support sling and disposable introducers. The Aris sling and introducers are indicated for the surgical treatment of all types of stress urinary incontinence (SUI) and for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The Supris Retropubic Kit consists of the Supris implantable midurethral support sling and disposable introducers for placement using a "top-down" or "bottom-up" retropubic surgical approach. The Supris sling and introducers are indicated for the surgical treatment of female stress urinary incontinence (SUI), resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Coloplast Altis Single Incision Sling (SIS) System includes one implantable single incision midurethral sling and two Altis introducer needles. The Altis Single Incision Sling System is provided sterile (ethylene oxide sterilization) and is for single use only. The Altis Single Incision Sling is an implantable, synthetic, knitted, low-elasticity, monofilament polypropylene, single incision midurethral sling. The mesh sling body measures approximately 7.75 cm long by 1.1cm wide. The Altis sling assembly is connected on each end to an anchor. One end of the sling assembly is connected to a short length of USP size 1 polypropylene monofilament suture connected to a static (non-tensioning) polypropylene anchor. The other end of the sling connects to a longer length of suture with a dynamic (tensioning) polypropylene/polyurethane anchor. The dynamic anchor is intended to allow intraoperative adjustment and tensioning of the sling, resulting in urethral support during instances of increased abdominal pressure, thereby preventing urine leakage. The Altis sling is non-absorbable and is intended to be permanent. The Altis introducers are helical-type instruments (one right), used to assist in the surgical placement of the Altis Single Incision Sling a transobturator technique, via a single incision vaginal approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Altis Single Incision Sling System in accordance with the Instructions for Use. The Coloplast Aris Transobturator Sling System includes an implantable midurethral sling and disposable introducer needles. The Aris sling and Aris introducers are provided sterile (ethylene oxide sterilization) and are for single use only. The Aris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Aris sling is non-absorbable and intended to be permanently implanted. Aris introducers (helical pair and flat curve) are instruments used to assist in the correct surgical placement of the Aris sling via the transobturator approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Aris sling. The Coloplast Supris Retropubic Sling System includes an implantable midurethral sling and disposable introducer needles. The Supris sling and Supris introducers are provided sterile (ethylene oxide sterilization) and are for single use only. The Supris sling is a synthetic, knitted, low-elasticity, midurethral sling made from monofilament polypropylene. The Supris sling is non-absorbable and intended to be permanently implanted. The Supris introducers are instruments used to assist in the correct surgical placement of the Supris sling via a retropubic approach. The introducers are manufactured from polycarbonate (handles) and medical grade stainless steel (needles). These introducers are only to be used with the Supris sling.

The Altis® Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Coloplast Altis Single Incision Sling (SIS) System includes an implantable, non-absorbable, single incision mid-urethral sling and disposable introducer needles for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Altis sling is knitted to 1.1 cm width using a 0.08mm (nominal) diameter polypropylene filament and is 7.75 cm long. The Altis sling and Altis introducers are provided sterile (ethylene oxide sterilization) and are for single-use only.

The Desara One mid-urethral mesh implant is intented for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The Desara One introducer is intended for the placement of the Desara One single incision mesh implant.

Desara® One Single Incision Sling System

The Altis Single Incision Sling System is indicated for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The Altis System is a single-incision mini-sling.. The sling material is manufactured using the commercialized Aris polypropylene mesh (K050148). Altis sling is made of a 0.08mm (nominal) diameter monofilament polypropylene mesh, knitted into a sling 1.1 cm wide by 7.75 cm long. One end of the sling assembly connects to a short length of USP size 1 monofilament polypropylene suture and to a polypropylene static (non-tensioning) anchor. The second side of the sling assembly terminates to a longer section of USP size 1 monofilament polypropylene suture. This suture is then positioned through the second anchor that is dynamic with an integrated tensioning system. The tensioning capability is accomplished by threading the suture through a polyurethane tensioning collar which is assembled onto the anchor. The anchor/suture assembly wraps around the anchor, resulting in a gap between the anchor and the collar providing constant pressure on the suture, preventing it from moving on its own, or during a pelvic stress event. Tensioning is achieved by pulling on the suture loop, thus applying increased tension of the sling to the urethra until desired support is achieved. The Altis anchors perform an acute mechaning the desired position and tension through the acute post-operative tissue healing and in-growth phase, The Altis sling assembly is packaged with two (2) helical type introducers (one right, one left) that are used to place the sub-urethral sling. The Altis introducers are designed with the appropriate curvature and length to reach the obturator foramen through a single vaginal incision. The tip of the needle is designed to fit into the anchors to facilitate placement into the obturator foramen during the surgical implant procedure. The sling assembly pouch and introducers are placed in a tray sealed with a Tyvek lid. The Altis system (implant plus introducers) is provided sterile (ethylene oxide) and is for single use only.

Ajust® Helica! Adjustable Single-Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Ajust® Helical Adjustable Single-Incision Sling System is a sterile, single use procedure kit that consists of a mesh sling implant and instruments, flexible stylet and two helical shaped introducers, which aid in the placement of the mesh in the pelvic floor. The product is offered in a single kit and dispenser pack of 5 individual kits. The sling implant is composed of four primary components - polypropylene flat mesh, polypropylene tube mesh, polypropylene anchors and a polypropylene sling lock. The adjusting tab is only used during adjustment and is not part of the permanent implant. The flexible stylet is a thin, flexible, Nitinol wire that allows the stylet to conform and flex to follow the path of the tube mesh to push the sling lock into position. The stainless steel helical shaped introducers allow for placement of the anchors in the obturator membrane/muscle by rotation of the handle of the introducer.

The MiniArc® Pro Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The MiniAre Pro Sling System is designed to treat female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The sling is comprised of a piece of polypropylene monofilament mesh with polypropylene self-fixating tips (anchors), a mid-line mark, and elongation feedback system. The elongation feedback system is attached to the sling intraoperative adjustment/tensioning and allows for objective measurement of sling elongation during the implant procedure. The sling is intended to remain in the body as a permanent implant with the polypropylene self-fixating tips providing short-term fixation prior to tissue in-growth. The elongation feedback system is intended to be removed prior to closure of the vaginal incision. The delivery tool (needle) is designed to interface with the self-fixating tips and deliver it to the obturator internus muscle, retaining the self-fixating tip until it is selectively released by the physician.

Ophira™ Mini Sling System is intended to be used for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

Ophira™ Mini Sling System consists of a sterile polypropylene sling and a sterile retractable insertion guide for sling placement. The sling is composed of monofilament polypropylene mesh between two polypropylene fixation arms; the fixation arms have multiple fixation points along the arms, which is the basis of the autofixing system, i.e., the two fixation arms are self anchored to the internus transobturator muscle and, therefore, the sling needs no sutures. An easily identifiable mark in the center of the mesh sling helps to achieve a symmetrically centered location for the proper placement of the sling. The sling has a suture inserted onto each fixation arm to provide the ability to adjust tension, if necessary, during the procedure for optimum suburethral support. These sutures are removed once the implantation procedure is completed.

Desara Mini is intended to be used in females to position a suburethral mesh sling for treatment of Genuine Stress Urinary Incontinence (SUI) and mixed incontinence resulting from urethral hypermobility. The mesh is placed transvaginally using a reusable introducer (sold separately)

The Desara Mini is a sterile, single-use pubourethral sling. The device is comprised of monofilament polypropylene yarn, which is knitted into a mesh, two self-fixating tips and two guiding suture loops at each end of the device. The device contains a visible midline marker to assist the surgeon in placement of the device. The Desara Mini is available in one configuration and a reusable introducer is available separately.

The MiniArc Precise™ Single-Incision Sling System is intended for the placement of a sub-urethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD).

The MiniArc Precise Single-Incision Sling System (MiniArc Precise) is a modification of the currently commercialized device, MiniArc Single-Incision Sling System (MiniArc), which consist of one sterile mesh sling and one sterile surgical instrument · used for sub-urethral sling placement. The minor modifications to MiniArc for the development of the MiniArc Precise are as follows: Self-fixating tips on the mesh sling are for a "secure connection" (snap-fit) to 0 the delivery tool needle tip. Delivery tool has an actuating needle tip release mechanism for the mesh sling. ● Mesh slings center-length dimensions are modified and the mesh sling arms 0 are knit with reinforcement fibers. The MiniArc Precise is available in two configurations; each configuration contains one sterile mesh sling and one sterile delivery tool. The identical delivery tool is used with both configurations. The configurations are identified by the mesh sling option, either the short center-length mesh or the long center-length mesh. The mesh sling and mesh arms material for MiniAre Precise is the same knitted polypropylene monofilament material used in the predicate, MiniArc. MiniArc Precise uses the same surgical approach and the same mesh placement procedures as the predicate device. MiniArc. The MiniArc Precise device is for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). MiniArc Precise device is for single use only and is not to be re-sterilized.

The Ajust™ Adjustable Single Incision Sling is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

The Ajust™ Adjustable Single Incision Sling is for use in urological and gynecological procedures for the treatment of stress urinary incontinence in women. The sling is secured in the patient's tissue using two soft tissue anchors. An introducer is used to insert the anchors using a similar approach to a transobturator sling. The implant design allows independent adjustment of the mesh relative to the anchors, after which, the mesh is secured in place using a small locking mechanism.