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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.

SAFYRE VS and SAFYRE T are to be permanently implanted in women, for the treatment of stress urinary incontinence grades II and III (due to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.

PROMEDON's Slings, SAFYRE VS and SAFYRE T, are manufactured with biocompatible silicone elastomers and polypropylene. Each sling is a permanent implant and is offered as a single use sterile product. Safyre consists of a monofilament polypropylene mesh between two silicone columns that are made of multiple coneshaped soft tissue anchors. These units are the basis of the self anchoring system. The polypropylene mesh lies on the mid-urethra and the interconnective tissue grows among its pores, between the vaginal flap and the urethra, which leads to integration of the implant without a loss of vascularization between the bladder and the vagina. The two columns are fixed to the abdominal fascia or the obturator muscle. This self . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . enough to keep the sling in its place when there is an important muscular activity, such as coughing or other strains. SAFYRE VS consists of a sling and a pair of single-use surgical instruments to facilitate its vaginal or suprapubic implantation ; while SAFYRE T is made up of the same sling, only varying in length with respect to the model VS, and a needle intended for the transobturator technique. Both are supplied with the surgical instruments to aid implantation.

Safyre Sling is to be permanently implanted in women, for the treatment of stress urinary incontinence grades II and III (due to bladder hypermobility and/or Intrinsic Sphincter Deficiency) acting as a urethral support.

PROMEDON's Sling, SAFYRE, is manufactured with biocompatible silicone elastomers and polypropylene. It is a permanent implant and is offered as a single use sterile product. Safyre consists of a pierced polypropylene mesh between two silicone columns that are made of multiple cone-shaped soft tissue anchors. The e units are the basis of the self anchoring system. The polypropylene shilles on the mid-urethra and the interconnective tissue grows among me the perforations between the vaginal flap and the urethra, which leads to internation of the implant without a loss of vascularization between the bladder and the vagina. The two columns are fixed to the abdominal fascia. This self anchoring is enough to keep the sling in its place when there is an important muscular activity, such as coughing or other strains.